Oncology

Brain Stem Cells Against Cancer?

2007-11-06T07:27:00.000-08:00

Gliomas are a group of brain tumors where the most common type is also the most aggressive one. Chemotherapy and radiation have little effect on malignant gliomas, and patients survive only about a year after being diagnosed. But research at Lund University in Sweden provides hope that it may be possible in the future to develop stem cells from the brain into a new way to treat gliomas.

Neural stem cells have been shown to have the ability to recognize signals from tumor cells in the brain and migrate there. If stem cells are injected into a part of the brain in laboratory animals with a glioma in another part of their brain, the stem cells migrate over to the tumor area.

This has spawned the idea of having stem cells transport drugs or immune stimulants to the tumor. This was the principle the Lund scientists wanted to test. But as it turned out, no extra assistance was needed: the stem cells themselves had the ability to combat the tumor.

"We were truly amazed when we saw this effect! To be sure about the phenomenon, we ran several experiments with other stem cells, and it was confirmed that certain neural stem cells actually have an anti-tumor effect," says Karin Staflin. She is describing the findings in her dissertation, which she will soon defend.

It is as yet unknown just why this happens. One plausible reason is that both normal neural stem cells and glioma cells are immature, not fully mature cells. They are therefore more like each other than any other types of cells in the brain, which may enable them to 'speak' to each other and influence each other. The research team at Lund has also shown that stem cells can cure colon cancer in lab animals.

"Cells in aggressive malignant cancer forms are often characterized as being more immature than their environment. This may be what enables neural stem cells to affect intestinal cancer cells," says Karin Staflin.

Many years of research remain before the newly discovered principle is ready to be tested on humans. First, researchers need to learn to understand the mechanisms better and identify the factors in neural cells which make them so effective. The notion is still new, but it does provide a glimmer of hope for a cure for a thus far incurable disease.

The dissertation is titled Neural progenitor cells in malignancy and injury of the brain: A Trojan horse for gliomas?

The Swedish Research Council

The Swedish Research Council bears national responsibility for developing the country's basic research towards attainment of a strong international position. The Council has three main tasks: research funding, science communication and research policy. Research is the foundation for the development of knowledge in society, and the basis of high-quality education. Research is also crucial as a means of enhancing welfare through economic, social and cultural development.

http://www.vr.se

Brain Stem Cells Against Cancer?

2007-05-07T11:05:00.001-07:00

Researchers Urge Monitoring Of Bone Health During Chemotherapy

2007-05-07T09:04:00.001-07:00

In laboratory tests on mice, researchers found that a medication often used to reduce toxic side effects of chemotherapy induced bone loss and helped tumors grow in bone. So the researchers at Washington University School of Medicine in St. Louis are recommending increased awareness of bone health during cancer treatments.

The medication studied is a growth factor commonly used to help cancer patients recover healthy blood counts after chemotherapy, which can destroy white blood cells. Low levels of white blood cells leave patients susceptible to infection.

"This growth factor encourages bone breakdown, and any therapy that decreases bone density could potentially enhance tumor growth in bone," says senior author Katherine Weilbaecher, M.D., assistant professor of medicine and of cell biology and physiology. "But there are things that can be done to counteract this. Physicians should carefully monitor their cancer patient's bone health with regular bone density scans (DEXA) and prescribe medications to prevent bone loss when needed. And patients should consume enough calcium and vitamin D and get sufficient exercise to maintain strong bones."

Weilbaecher and her colleagues found that when they gave mice an eight-day course of the growth factor, called granulocyte colony-stimulating factor (G-CSF), the mice lost bone mass and experienced increased bone tumor growth when injected with cancer cells. Their study will appear in an upcoming issue of the journal Blood and is now available online.

G-CSF is known by the trade names Neupogen, Neulasta and Granocyte. Clinical use of G-CSF has recently increased because by speeding blood cell regrowth it allows patients to undergo more intensive chemotherapy regimens in which anticancer agents are given at more frequent intervals. Studies have suggested these dose-dense therapies could prolong survival in women with breast cancer.

"We are not at all advocating ending G-CSF use," says Weilbaecher, an oncologist with the Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital. "G-CSF seems to have significant benefits for some cancer patients."

Although G-CSF had a strong effect on bone metastasis in the experimental mice, early clinical trials in humans using G-CSF with chemotherapy have so far shown no adverse effects on survival and no increase in bone metastasis. In fact, breast-cancer patients undergoing dose-dense chemotherapy with G-CSF support tend to have a longer disease-free period than those getting standard dosing without G-CSF.

"It's possible that women on G-CSF-supported chemotherapy could do even better if we paid more attention to skeletal health," says lead author Angela Hirbe, an M.D./Ph.D. student in Weilbaecher's lab. "Strengthening the skeleton would not only help prevent osteoporosis and fractures but also might give patients a survival advantage."

In the laboratory mice studied, G-CSF increased the number and activity of bone cells called osteoclasts, which resorb bone material as part of the normal process of bone turnover. The resulting loss of bone density created a favorable environment for bone tumor growth.

When the researchers injected melanoma or breast cancer cells into mice, those getting G-CSF developed a two-fold increase in tumor burden, a measure of the size and severity of tumors, compared to those that did not receive G-CSF.

Interestingly, mice treated with a bisphosphonate, an anti-osteoporosis agent that inhibits osteoclasts, were resistant to the effects of G-CSF on bone tumor growth. Weilbaecher is currently investigating bisphosphonates as a means to prevent tumor metastasis to bone in breast cancer patients.

"We used G-CSF as a tool to understand the implications for tumor growth when osteoclast activity is revved up," Weilbaecher says. "But G-CSF isn't unique in its effect. For example, antihormone therapies used to treat breast and prostate cancer also can decrease bone mineral density. We would like to see clinical trials instigated to study the effects of such cancer therapies on bone health and tumor metastasis."

Hirbe AC, UluÃ§kan -, Morgan EA, Eagleton MC, Prior JL, Piwnica-Worms D, Trinkaus K, Apicelli A, Weilbaecher K. Granulocyte colony-stimulating factor enhances bone tumor growth in mice in an osteoclast-dependent manner. Blood Dec 27, 2006 (advance online publication).

Funding from the National Cancer Institute supported this research.

Washington University School of Medicine's full-time and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children's hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked fourth in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children's hospitals, the School of Medicine is linked to BJC HealthCare. Siteman Cancer Center is the only NCI-designated Comprehensive Cancer Center within a 240-mile radius of St. Louis. Siteman Cancer Center is composed of the combined cancer research and treatment programs of Barnes-Jewish Hospital and Washington University School of Medicine.

Washington University in St. Louis
One Brookings Dr., Campus Box 1070
St. Louis, MO 63130
United States
http://www.wustl.edu/

High-Power MRI Helps Surgical Team Predict Outcomes In Unusual Tumor Cases

2007-05-07T08:04:00.001-07:00

A Mayo Clinic surgical team has found that using a 3-Tesla MRI in surgical decision making provides a new level of capability to predict surgical outcomes that improves patient care by minimizing the potential for unsuccessful tumor-removal surgeries. The Mayo Clinic report appears in the December issue of the Journal of Neurosurgery.

In their report, Mayo physicians describe a case study of five patients. Four had neurofibromatosis, a condition with a predisposition to nerve-related tumors. All patients suffered from growths called "sciatic notch dumbbell-shaped" tumors. The tumors were benign, but resulted in neurologic dysfunction and disabling pain.

"In the past, if surgeons couldn't tell prior to surgery where the exact location of the large tumor was in relation to the sciatic nerve, it meant they couldn't predict in which cases surgery could be performed safely," explains Robert Spinner, M.D., the lead neurosurgeon on the Mayo Clinic team.

The team used an advanced magnetic resonance imaging (MRI) system performed on a 3-Tesla magnet to help identify suitable candidates for a difficult tumor-removal surgery. A Tesla is a unit of magnet strength. A 3-Tesla is one of the strongest commercially available.

Significance of the Mayo Clinic Case Study

A standardized surgical approach for safe and complete removal of sciatic notch dumbbell-shaped tumors has been problematic for at least three reasons. These tumors are:

-- relatively rare and therefore hard to study

-- anatomically difficult to reach and remove without injuring the main sciatic nerve

-- difficult to visualize before surgery with enough detail to distinguish tumor boundaries from nerve

The current Mayo Clinic report begins to change this situation by documenting a new multidisciplinary approach for obtaining the desired favorable surgical outcomes.

Surgeons need an accurate picture of how and whether they can remove a tumor while protecting a nerve. Otherwise, patients may be exposed to the risks of surgery without achieving surgical benefits if the tumor is inoperable because complete removal would damage a nerve. "Our experience demonstrates the advantages of predictive imaging at the outset," says Dr. Spinner. "With an integrated team of surgeons from three specialties, and an experienced radiologist specializing in advanced peripheral nerve imaging using the 3-Tesla MRI, we have devised an approach that minimizes unsuccessful tumor-removal surgeries."

About the Study

With the 3-Tesla MRI images, Mayo Clinic surgeons from three specialties -- neurosurgery, colorectal and orthopedic surgery -- obtained sufficiently detailed pictures of the tumor and nerve relationship before surgery in all five cases to accurately predict which patients would benefit from surgery. In three cases the tumor was predicted to be distinct from the main sciatic nerve, and the tumor was safely removed. All three patients experienced relief from pain and had no recurrent growth one year after surgery. In the other two cases, the tumor was predicted to be so entwined in the nerve that surgery would have damaged the nerve. Those patients did not undergo surgery.

Dr. Spinner said the team will continue to refine the approach to improve the care that these patients receive. "This new technology allows a multidisciplinary approach to be performed safely in these rare tumors that were once considered unresectable," he says. "In addition, the same techniques that we have developed have tremendous applications to many patients who have peripheral nerve tumors in more common locations."

Collaboration

Other members of the Mayo Clinic team included: Toshiki Endo, M.D.; Kimberly Amrami, M.D.; Eric Dozois, M.D.; Dusica Babovic-Vuksanovic, M.D.; and Franklin Sim, M.D.

Mayo Clinic
200 First St. SW
Rochester, MN 55902
United States
http://www.mayoclinic.com/

Blog Carnival Edit

2007-05-07T08:02:00.000-07:00

Cancer blogs carnival

Vahid Chaychi presents Coping with Depression When You Have Cancer posted at Cancer and Health Topics.

Andrea Dickson presents The Cost of Tanning posted at Wise Bread - Living large on a small budget.

Vahid Chaychi presents HPV (cause of cervical cancer) Vaccine Causes Controversy posted at Healthoma.com.

See the top online resources for prostate... posted at Prostate cancer treatment

Newly Released Prisoners At High Risk For Death

2007-05-07T07:05:00.001-07:00

Prisoners who have been recently released from prison have a high death rate, especially in the first two weeks after release, a new study finds. The findings will be published in the Jan. 11 issue of The New England Journal of Medicine.

The study was conducted by Ingrid Binswanger, MD, of the University of Colorado at Denver and Health Sciences Center's School of Medicine, Marc Stern, MD, health services director of the Washington State Department of Corrections, and other researchers at the University of Washington and Harborview Medical Center in Seattle. Binswanger conducted the research while taking part in the Robert Wood Johnson Clinical Scholars Program at the University of Washington and the VA Puget Sound Health Care System.

In the first study of its kind in the U.S., Binswanger analyzed data from 30,237 inmates released from prison between 1999 and 2003 in Washington state. The sample represented almost all prisoners released during that time. Of those individuals, 443 died during an average follow-up time of 1.9 years.

The death rates of the released prisoners were compared to the death rates of other Washington residents of the same age, gender, and race. The study found that newly released prisoners were 12.7 times as likely to die in the two weeks following their release compared to other state residents in the same demographic groups. Over the whole study, the former inmates were 3.5 times more likely to die than other state residents. The death rate among former inmates was considerably higher than the death rate among inmates in prison.

"These striking findings suggest that former inmates are at high risk for death following their release from prison," said Binswanger. "These results, along with findings from studies done in other countries, underscore the need for novel programs to reduce the risk of death in former inmates."

The leading causes of death were drug overdose, cardiovascular disease, homicide and suicide. Nearly one quarter of the deaths were a result of drug overdose, and half of these deaths resulted from cocaine. After cocaine, most overdose deaths were caused by methamphetamine and opiates like heroin. Lung cancer represented half of all the cancer deaths in this population.

Younger individuals tended to die from overdose, homicide and suicide, whereas older individuals tended to die from cardiovascular disease and cancer. Binswanger recommends programs targeted by age to address this difference.

"The U.S. has exceptionally high rates of incarceration," said Binswanger. "When a released prisoner dies, it may have an impact beyond his own life, affecting families and communities. These findings suggest that we need programs and policies targeted at decreasing the risk of death as former inmates transition back into their communities."

Binswanger is a physician researcher and an assistant professor in the Division of General Internal Medicine at UCDHSC's School of Medicine. Her research focuses on health, the criminal justice system, and vulnerable populations.

The School of Medicine faculty work to advance science and improve care as the physicians, educators and scientists at University of Colorado Hospital, The Children's Hospital, Denver Health, National Jewish Medical and Research Center and the Veterans Administration Medical Center. The School is part of the University of Colorado at Denver and Health Sciences Center, one of three universities in the University of Colorado system. For more information, visit the Web site at http://www.uchsc.edu or the UCDHSC Newsroom at http://www.uchsc.edu/news.

University of Colorado at Denver and Health Sciences Center
Mail Stop F-413 PO Box 6508
Aurora, CO 80045-0508
United States
http://www.uchsc.edu/

Study Shows Potential Of Targeted Microbubbles Using Peregrine's VTA Technology To Identify Which Cancer Patients Would Benefit

2007-04-16T16:56:00.001-07:00

Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing targeted therapeutics for the treatment of cancer and hepatitis C virus (HCV) infection, today announced publication of a study demonstrating that microbubbles targeted to tumor blood vessels can be used to monitor patient response to anti-angiogenesis therapy, identifying at an early stage which cancer patients are benefiting from the treatment. This information could allow oncologists to modify patient treatment regimens soon after starting therapy, so that non-responders could be switched to other therapies that might be more effective for them. The potential of the approach is enhanced by the fact that the targeted microbubbles are "read" using ultrasound technology, which is widely available in most physicians' offices and is minimally invasive, safe and cost-effective.

The research, the results of which appear in the January 1, 2007 issue of Clinical Cancer Research, was conducted by scientists at the University of Texas Southwestern Medical Center and funded by Peregrine. The published article demonstrates the potential of Peregrine's Vascular Targeting Agent (VTA) technology platform for imaging and diagnosis of solid tumors using agents targeted to tumor blood vessels. Patents covering Peregrine's VTA technology platform have been exclusively licensed from the UT Southwestern Medical Center. The "personalized medicine" made feasible by this approach has the potential to increase the efficacy of cancer regimens, reduce side effects from ineffective treatments and improve the overall cost effectiveness of cancer therapy.

Anti-angiogenesis agents such as Avastin(R) treat cancer by preventing the formation of tumor blood vessels, thereby "starving" tumors. They are increasingly being used in combination with chemotherapy agents as cornerstones of cancer therapy, yet not all patients actually respond to the approach (the patient response rate in two recent studies ranged from 26% to 35%). The ability to determine which cancer patients are responding to anti-angiogenesis treatment early in the process could enable oncologists to ensure that each patient was receiving the therapy that is most effective for their specific condition, while reducing the risk of side effects from ineffective treatments and also enabling the health care system to avoid large expenditures on regimens that ultimately produce little therapeutic benefit.

"We believe this study demonstrating the potential utility of targeted microbubbles could be a breakthrough in developing cost-effective methods for monitoring the effectiveness of anti-angiogenesis therapies which may have great clinical and commercial significance," said Steven W. King, president and CEO of Peregrine. "This technology could have potential not only for evaluating the effectiveness of currently approved agents such as Avastin(R) but also for assessing new anti-angiogenesis approaches currently in clinical development, and eventually for evaluating the effectiveness of anti-angiogenic agent cocktails, which are likely to be developed as more products in this class are approved. We look forward to continuing our collaboration with the researchers at UT Southwestern to advance this technology toward human clinical studies in order to fully evaluate its potential."

The UT Southwestern researchers, led by Dr. Rolf Brekken, tested the targeted microbubble approach in several mouse models of pancreatic cancer, a particularly aggressive and lethal disease. The microbubbles are tiny lipid or albumin shells filled with an inert gas that have a well-established safety record as contrast agents for ultrasound imaging applications, and they are currently widely used in cardiovascular medicine.

In the reported studies, Dr. Brekken and his colleagues linked the microbubbles to antibodies that target them to specific markers on tumor blood vessels. The microbubbles were then administered to tumor-bearing animals and ultrasound images of the tumor were recorded. The ultrasound images identified the number of tumor blood vessel markers that were present before and after treatment with several anti-angiogenic agents, including Avastin and 2C3, a novel anti-angiogenic antibody in preclinical development by Peregrine. A decrease in the number of tumor blood vessel markers indicated that the treatment was working as intended. The researchers determined that measurements of tumor blood vessel markers made using the microbubble approach correlated well with measurements made using conventional invasive techniques.

"These encouraging results indicate that targeted microbubble contrast agents could be a robust and accessible method for increasing the utility and cost-effectiveness of anti-angiogenic cancer treatments," said Dr. Brekken, assistant professor of surgery and pharmacology, a researcher at the Nancy B. and Jake L. Hamon Center for Therapeutic Oncology Research and Effie Marie Cain Research Scholar in Angiogenesis Research at UT Southwestern. "The ability to rapidly monitor and modify therapy would be valuable for patients, physicians and the larger healthcare system. The clinical development of contrast agents is typically faster than for therapeutics, and clinical trials of this approach could be feasible within 12 to 18 months. We look forward to working with Peregrine to advance this potentially important new approach."

The article, "Monitoring Response to Anticancer Therapy by Targeting Microbubbles to Tumor Vasculature," is published in Clinical Cancer Research 2006:12(23) January 1, 2007.

About Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing five separate clinical trials in cancer and HCV infection in the U.S. and India with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.

Safe Harbor Statement:

Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that use of targeted microbubbles to monitor patient response to anti-angiogenesis therapy may not be as effective when used in connection with human patients. It is important to note that the company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the Company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2006, and the quarterly report on Form 10-Q for the quarter ended October 31, 2006. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

Peregrine Pharmaceuticals, Inc.
http://www.peregrineinc.com

Aida Pharmaceuticals Receives Approval And Commences Phase II Trials Of Potential Cancer Treatment

2007-04-16T16:16:00.001-07:00

Aida Pharmaceuticals, Inc. (OTC Bulletin Board: AIDA), one of mainland China's leading pharmaceutical companies, today announced that the State Food and Drug Administration (SFDA) of China has officially approved the commencement of Phase II clinical trials of the genetic cancer treatment Rh-Apo2L,the Category A biopharmaceutical currently in development phase by the Company's subsidiary Shanghai Qiaer Biotechnology Co., Ltd.

Aida Pharmaceuticals previously announced its plans to begin Phase II trials throughout mainland China this year. These trials will take place in approximately 20 hospitals in major metropolitan candidate areas including Beijing, Tianjin, Shanghai, Hangzhou, Nanjing, Suzhou, Fuzhou, Hefei, Jinan, Chengdu, Changsha, Wuhan, Dalian and Guangzhou. The Phase II trials will analyze the effect of Rh-Apo2L on two types of tumors chosen from the following cancers: advanced inert lymphoma, malignant melanoma, soft tissue sarcoma, pancreatic cancer, kidney cancer, non-small cell lung cancer and colorectal cancer. The trials will analyze the specific efficacy of Rh-Apo2L in approximately 100 patients. Additionally, the Company will continue to analyze the dosage and effectiveness of the drug as well as other drugs' interactions with Rh-Apo2L.

Chairman of Aida Pharmaceuticals, Jin Biao stated, "This approval will allow us to contiguously move forward with our development plans for Rh-Apo2L. This potentially revolutionary cancer treatment has received a great deal of attention this year including awards and grants from the state and federal governments. Last quarter, Aida announced plans to build a GMP certified manufacturing facility for Rh-Apo2L. The facility will be built in the Jianggan Hi-Tech development zone in Hangzhou, China. We remain on track to break ground on the project early this year and we anticipate the phase I construction to be completed by year-end 2007. This facility will have the final capacity to produce up to eight million doses of Rh-Apo2L. We believe that we have the resources and man power to finish Phase II and Phase III trials in order to bring Rh-Apo2L to market by 2008. In its first year of production, pending all necessary approvals and allowances, we believe Rh-Apo2L will generate potential EBITDA of $50 million on potential sales of $75 million."

About Rh-Apo2L:

Rh-Apo2L is Category A, anti-tumor biological agent researched and developed by Shanghai Qiaer Biotechnology Co., Ltd., a newly acquired subsidiary of Aida Pharmaceuticals. Rh-Apo2L is a broad spectrum genetic cell apoptosis (cell- killing) agent, which the Company expects to be used for the treatment of a variety of cancerous tumors. Research and Development of Rh-Apo2L is sponsored and supported by several national and municipal funds. One patent of Rh-Apo2L has been granted by Chinese Patent Bureau, two additional patents are currently in process.

About Aida Pharmaceuticals:

Aida Pharmaceuticals is a product-focused pharmaceuticals company engaged in the formulation, clinical testing, registration, manufacture, sales and marketing of advanced pharmaceutical and genetic products in mainland China. The Company's mission is to discover, develop and market meaningful new therapies that improve human health. Aida Pharmaceuticals, in operation since March 1999, is headquartered in Hangzhou, China with manufacturing, distribution and sales points throughout mainland China. Aida is GMP certified in China and ISO9002 certified for quality assurance and ISO14000 certified for ecologically-friendly practices. Aida is now producing and marketing a patented prescription drug in China: Etimicin Sulfate. It is the first antibiotic developed in China and is regarded as a category "A" drug by the State Food and Drug Administration of China.

Safe Harbor Statement:

Under the Private Securities Litigation Reform Act of 1995: This press release includes certain "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995. These statements are based on Aida Pharmaceuticals, Inc.'s management's current expectations and are subject to risks and uncertainties and changes in circumstances. All forward-looking statements included in this press release are based upon information available to Aida Pharmaceuticals, Inc. as of the date of the press release, and it assumes no obligation to update or alter its forward looking statements whether as a result of new information, future events or otherwise. These forward-looking statements may relate to, among other things, plans and timing for the introduction or enhancement of our services and products, clinical trial results, statements about future market conditions, supply and demand conditions, and other expectations, intentions and plans contained in this press release that are not historical fact. Further information on risks or other factors that could affect Aida Pharmaceuticals, Inc.'s results of operations is detailed in its filings with the United States Securities and Exchange Commission available at http://www.sec.gov.

Aida Pharmaceuticals, Inc
http://www.aidapharma.com/

Curing Kids' Cancer Announces 2006 Pediatric Cancer Research Grants

2007-04-16T14:56:00.001-07:00

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins has been named the primary recipient of the 2006 grants from Curing Kids' Cancer, the charity that raises money for leading edge pediatric cancer research through kids' sports teams and school children.

A $100,000 grant was given to Johns Hopkins for research into new targeted therapies for acute lymphoblastic leukemia, the most common childhood cancer. The project, led by Dr. Curt Civin, is part of the combined efforts at the Johns Hopkins Kimmel Cancer Center and the National Cancer Institute.

"We are thrilled to help fund this promising research at Johns Hopkins," said Grainne Owen, co-founder of Curing Kids' Cancer. "We are determined to help the doctors find cures for childhood cancers -- turning it from a killer disease into just another curable childhood illness -- in our lifetime."

"We're honored to receive this grant from Curing Kids' Cancer," said Dr. Civin. "We're especially honored because the money was raised by children who want to help other children diagnosed with cancer."

The Aflac Cancer Center & Blood Disorders Service of Children's Healthcare of Atlanta was awarded a $20,000 grant to fund pediatric clinical trials and research to get new drugs "from the bench to the bedside."

Curing Kids' Cancer also awarded a $10,000 grant to Baylor College of Medicine/Texas Children's Cancer Center to support Dr. Jason's Shohet's research towards developing novel treatments for neuroblastoma at Texas Children's hospital. Neuroblastoma is a disease in which malignant cancer cells form in nerve tissue of the adrenal gland, neck, chest, or spinal cord. Neuroblastoma most often begins during early childhood, usually in children younger than 5 years old. The average five-year survival rate for children with neuroblastoma is 30 percent.

Smaller grants were also awarded to Palmetto Heath Children's Hospital, Columbia, SC, and Los Angeles Children's Hospital to fund clinical trials of new drugs, conduct research and develop innovative treatment options for pediatric cancer patients.

Curing Kids' Cancer has two national grassroots programs -- Coaches Curing Kids' Cancer and Teachers Curing Kids' Cancer. Both programs urge parents and children to donate money to pediatric cancer research in the name of their coach or teacher rather than buying gifts. Details of the programs are available at http://www.curingkidscancer.org.

The grant to Johns Hopkins was made by Curing Kids' Cancer based on the advice and recommendations of the charity's Medical Advisory Board, consisting of 14 top pediatric oncologists and researchers from the United States and Canada. Members of the board who applied for a grant did not review the grant applications or vote for the awards.

About Curing Kids' Cancer

Inspired by nine-year-old Killian Owen's battle with leukemia, Curing Kids' Cancer Inc. is a unique, national grassroots movement which aims to raise both awareness and money to find cures for all types of childhood cancer. Our programs fund the development of cutting edge therapies which will revolutionize childhood cancer treatment by replacing traditional chemotherapy. Our objective is to turn this killer disease into a curable one in our lifetime. Details are available at http://www.curingkidscancer.org.

Curing Kids' Cancer
http://www.curingkidscancer.org

New Treatment For Schistosomiasis (Bilharzia)

2007-04-16T14:16:00.001-07:00

A significant reduction in parasite burden and pathology by a vinyl sulfone cysteine protease inhibitor suggests a new direction for chemotherapy of human schistosomiasis.

Citation: Abdulla M, Lim KC, Sajid M, McKerrow JH, Caffrey CR (2007) Schistosomiasis mansoni: Novel chemotherapy using a cysteine protease inhibitor. PLoS Med 4(1): e14.

PL EASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT

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About PLoS Medicine

PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org/

About the Public Library of Science

The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource. For more information, visit http://www.plos.org/ CONTACTS:

Conor Caffrey
Sandler Center for Basic Research in Parasitic Diseases
Department of Pathology
QB3-Byers Hall, 1700 4th Street
San Francisco, CA 94158-2330 United States of America

Andrew Hyde
Public Library of Science

Non-prescription Compound Found In Chillies Destroys Cancer Tumours Safely

2007-04-16T12:50:00.001-07:00

UK scientists have shown that capsaicin, the chemical that burns your mouth when you eat chillies and an active ingredient of over the counter drugs, can kill cancer cells with little or no harmful side-effects.

The study is published in the journal Biochemical and Biophysical Research Communications.

The team that conducted the research came from the Universities of Nottingham in England and Cardiff, in Wales, and was led by Dr Timothy Bates, who is a member of the Medical Research Council (MRC) College of Experts.

The researchers believe that capsaicin, and other similar compounds, attack the mitochondria of cancerous cells, causing them to "switch off" and die (apoptosis, or cell death) without harming surrounding tissue. Mitochondria are organelles (tiny granules of tissue with their own DNA) that live inside the cells of our bodies and convert nutrients into ATP - the chemical fuel that feeds our cells with energy.

Dr Bates, who is an international expert in anti-cancer drug development and mitochondrial research in particular, said this discovery might explain the low incidence of cancer in countries where they eat a lot of chillies like Mexico and India.

From a development view this discovery is exciting for two reasons. First, because capsaicin and related compounds already exist in food that is eaten regularly, they are already safe, readily available and not unknown. Secondly, and perhaps more importantly as far as development costs and timescales go, these compounds have already been approved for use in a range of drugs such as skin ointments to treat psoriasis and neuralgia. Converting their use to treat cancer would be much cheaper and quicker compared to starting from scratch with a new compound.

Dr Bates and his colleagues tested the capsaicin on H460 human lung cancer cells, which is recognised as the "gold standard" for new anti-cancer drugs. However, they also tested similar compounds on pancreatic cancer cells and found the same effect - the tumour cells died off leaving the surrounding tissue intact. This is a very exciting result because pancreatic cancer has a five-year survival rate of less than one per cent and is currently one of the most stubborn cancers to treat.

The study that led to this discovery is the first to emerge from a newly formed Nottingham UK-China Collaboration on Complementary and Alternative Medicine (NUKCAM). The collaboration has members from the University of Nottingham and the Chinese National Academy of Sciences, for example Professor De-An Guo, who is head of the Shanghai Research Centre for the Modernization of Traditional Chinese Medicine. Prof Guo is working with Dr Bates to discover why traditional Chinese medicines are successful in treating cancer and other diseases.

Traditional Chinese Medicine (TCM) is considered an alternative medicine in the west. But in China it is an important part of the public health care system.

The last twenty or so years have seen an increasing interest on the part of the West and China to come together and explore this wealth of knowledge that dates back thousands of years. The main thrust of joint projects, like this one, is to examine the theories and uses of TCM using western scientific methods and tools.

Another important milestone in this East-West collaboration will be when The World Health Organization's (WHO) initiative to to standardize TCM nomenclature reaches conclusion. It is said to be in its final phases, and there is a paper on this by Tony Reid in the The Journal of Chinese Medicine.

As lovers of Sichuan food and dishes will know, chillies do feature prominently in the Chinese diet, and apart from adding fire and flavour are believed by local followers of Chinese medicine to help ward off the ills caused by their damp and muggy climate.

University of Nottingham, UK

English version of The Journal of Chinese Medicine.

Written by: Catharine Paddock
Writer: Medical News Today

AstraZeneca Announces Recentin(R) As Global Trademark For Novel Cancer Treatment, AZD2171

2007-04-16T12:10:00.001-07:00

AstraZeneca today announced RECENTIN™ as the global trademark for AZD2171, its oral, highly potent and selective vascular endothelial growth factor (VEGF) signalling inhibitor. AZD2171 is currently in Phase II/III development for advanced non-small cell lung cancer (NSCLC) and advanced colorectal cancer (CRC) - as well as a wide-ranging signal search programme in other tumours.

Ian Triggs, Global Brand Strategy Director for AZD2171 commented:
"The announcement of a brand name represents a key milestone in the development of AZD2171"

Dr Nick Botwood, Global Medical Director for AZD2171, added:
"Pre-clinical data shows this compound is a potent suppressor of angiogenesis - an established approach in anti-cancer treatment. More importantly, early clinical trial data has also shown encouraging anti-tumour activity with AZD2171 and a side effect profile that appears to be predictable and manageable. The ongoing trial programme will be important to establish how AZD2171 may add to the treatment options currently available to patients."

VEGF is a key driver of angiogenesis - the formation of new blood vessels. By inhibiting VEGF receptors, AZD2171 hinders angiogenesis, thus preventing the blood supply that tumours need to grow and spread. There are three VEGF receptors involved in tumour angiogenesis, (VEGFR-1, VEGFR-2, VEGFR-3).

AZD2171 inhibits all three,1 in particular VEGFR-2, the predominant receptor through which VEGF exerts its effect on angiogenesis.

RECENTIN™ is a trademark of the AstraZeneca group of Companies.

Ongoing clinical trials with AZD2171

The anti-tumour efficacy of AZD2171 is being evaluated in an extensive ongoing clinical development programme including studies in lung and colorectal cancer.

Lung cancer

Lung cancer remains the biggest cause of cancer death worldwide. Over 1.35 million new cases of lung cancer are diagnosed every year and nearly 1.2 million people die as a result of this disease - more than breast, colon and prostate cancer combined.2 A Phase II/III study, BR-24, being coordinated by the National Cancer Institute of Canada (NCIC), is comparing the efficacy of AZD2171 plus 'doublet' chemotherapy (paclitaxel and carboplatin) to 'doublet' chemotherapy alone in patients with advanced NSCLC.

Colorectal cancer

Colorectal cancer is the third most commonly reported cancer worldwide, with around 945,000 new cases and 492,000 deaths annually.3 It is ranked second in terms of both incidence and mortality in more developed countries.3

The Horizon Study Programme is ongoing to evaluate AZD2171 in patients with advanced colorectal cancer.

-- Horizon III is a Phase II/III randomised, double-blind, international multi-centre investigation of AZD2171 in combination with FOLFOX compared to bevacizumab (Avastin(R)) in combination with FOLFOX, in patients with previously untreated metastatic colorectal cancer.

-- Horizon II, a randomised, double-blind Phase III study will compare AZD2171 plus standard chemotherapy with standard chemotherapy alone in patients with first line advanced colorectal cancer.

-- Horizon I, a Phase II study, will evaluate AZD2171 in combination with FOLFOX compared to bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer.

About AZD2171

AZD2171 is a once-daily, orally available, highly potent and selective VEGF signalling inhibitor that inhibits all three VEGF receptors.1 The preclinical profile of AZD2171 indicates that it has the potential to be the 'best in class' VEGF signalling inhibitor.1

AZD2171 has shown encouraging signs of anti-tumour activity in a clinical development programme, which has included over 700 patients to date. Phase I data indicate that AZD2171 is generally well tolerated, with the most common dose related adverse events being diarrhoea, hoarseness, headache and hypertension.4

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

www.aztrazeneca.com

References

1 - Wedge SR, Kendrew J, Hennequin LF, Valentine PJ, Barry ST, Brave SR, Smith NR, James NH, Dukes M, Curwen JO, Chester R, Jackson JA, Boffey SJ, Kilburn LL, Barnett S, Richmond GH, Wadsworth PF, Walker M, Bigley AL, Taylor ST, Cooper L, Beck S, Jurgensmeier JM, Ogilvie DJ. Cancer Research 2005, 65: 4389-4400.

2 - Ferlay J, Bray F, Pisani P, et al. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide IARC CancerBase No. 5. version 2.0, IARCPress, Lyon, 2004.

3 - Stewart BW and Kleihues P (Eds): World Cancer Report. IARCPress. Lyon. 2003.

4 - Drevs J, Medinger M, Mross K, Zirrgiebel U, Strecker R, Unger C, Puchalski TA, Fernandes N, Roberston J, Siegert P. Proceedings from ASCO 2005, Abs 3002.

Young Single Men Are More Likely To Bank Sperm Before Testicular Cancer Treatment

2007-04-16T11:19:00.001-07:00

A quarter of men with testicular cancer banked their sperm before treatment, but only six per cent of those actually used the sperm to father a child, according to a study published in the January issue of the urology journal BJU International.

Researchers from the Vanderbilt University Medical Centre in Nashville, USA, surveyed 129 males treated at the institution over a ten-year period.

They discovered that 31 of the men (24 per cent) chose to bank their sperm before treatment, at an average cost of US $358. Maintenance fees added an average of US $243.86 a year.

Despite the cost, only two of the men use their banked sperm to father a child, one said he might use it in the future and a further 12 had children naturally.

Men who banked their sperm had an average age of 26 - ten years younger than those who didn't. They were less likely to have children at the time of diagnosis and more likely to have children after treatment.

And single men were twice as likely to bank their sperm (44 per cent) as married men (21 per cent).

The most common reasons given for not banking sperm were that they didn't want to have children, or more children, that they or their partner were infertile or they had already had a vasectomy.

38 per cent of all the men who took part in the survey hadn't had children at the time of diagnosis. 45 per cent of the men who had banked their sperm had children after treatment, compared with 14 per cent of the men who hadn't banked their sperm.

"As most men treated for testicular cancer are young and the survival rate exceeds 90 per cent, the issue of after-treatment fertility is important" says lead author Christopher R Girasole.

"Revolutionary techniques such as in vitro fertilisation and intracytoplasmic sperm injection make pregnancy possible with even the lowest quality of sperm.

"However, up to a quarter of men don't produce usable sperm after treatment.

"These factors probably explain why most urologists, radiation oncologists and medical oncologists offer sperm banking before therapy for testicular cancer.

"However, our survey shows that sperm banking costs are relatively high and usage is relatively low. We feel that patients should be counselled on both the costs and benefits of sperm banking before they receive treatment for testicular cancer."

The males who took part in the survey ranged from 14 to 76 years of age. The youngest man to bank his sperm was 18 and the oldest was 43.

###

* Sperm banking: use and outcomes in patients treated for testicular cancer. Girasole et al. BJU International. Volume 99, pages 33-36 (January 2007).

* Established in 1929, BJU International is published 12 times a year by Blackwell Publishing and edited by Professor John Fitzpatrick from University College Dublin, Ireland. It provides its international readership with invaluable practical information on all aspects of urology, including original and investigative articles and illustrated surgery. www.bjui.org

Contact: Annette Whibley
http://www.blackwellpublishing.com/

Tracing Agent, Ultrasound Combo Helps Test Cancer Therapy's Effectiveness

2007-04-16T11:07:00.001-07:00

An inexpensive tracing agent used in combination with ultrasound can pinpoint how effectively drugs targeting pancreatic cancer work, researchers at UT Southwestern Medical Center have demonstrated for the first time.

The study, involving human pancreatic tumor cells implanted in mice, opens a new avenue for real-time imaging of a patient's response to cancer therapies. It appears in the Jan. 1 issue of the journal Clinical Cancer Research.

The UT Southwestern research team focused on pancreatic cancer because it is one of the deadliest cancers, characterized by extensive local invasion and metastasis to the liver, said Dr. Rolf Brekken, assistant professor of surgery and pharmacology and the study's senior author. The five-year survival rate ranges from only 1 percent to 4 percent for patients diagnosed with the most severe form of cancer of the pancreas called pancreatic andenocarcinoma.

"The current best therapy - including surgery, radiation and chemotherapy - has done little to alter cancer-related deaths of these patients, emphasizing the need for more effective treatment," said Dr. Brekken, a researcher at the Nancy B. and Jake L. Hamon Center for Therapeutic Oncology Research at UT Southwestern.

The research team examined how pancreatic tumor cells respond to an experimental anti-cancer agent that targets vascular endothelial growth factor (VEGF), a protein responsible for triggering the development of blood vessels that deliver nutrients and oxygen to tumors, enabling them to grow and spread. Drugs that target VEGF are in a class called anti-angiogenic agents that are designed to choke tumor growth by reducing the number of blood vessels feeding the cancer.

"In general, it has been difficult to assess whether anti-angiogenic drugs are having an impact on tumors in human patients," said Dr. Brekken. "The sooner we can measure the effectiveness of the treatment, the earlier we can intervene to change anti-cancer agents if a particular drug has no effect. This could be a lifesaving approach in patients with rapidly fatal disease."

To find the answer, the UT Southwestern team resorted to an inexpensive and commonly used contrast, or tracing agent, called microbubbles. Each tiny bubble measures about one to two microns in diameter - about a hundredth the width of a human hair - and consists of albumin, sugar and an inert gas. Microbubbles are used routinely in echocardiography, for example, allowing cardiologists to see how efficiently and how much blood the heart pumps.

UT Southwestern researchers linked the microbubbles to a targeting agent that delivered the imaging agent to proteins or protein complexes on the surface of tumor blood vessels. They found that the ultrasound signal from the microbubbles decreased in mice that received therapy. The harmless microbubbles remained in the bloodstream and allowed researchers to use ultrasound to get a crisp picture of what was occurring on blood vessels inside the tumor, Dr. Brekken said.

In one of the studies reported, the researchers observed that blocking VEGF activity achieved a 40-percent reduction in mean tumor size after four treatments over a two-week period, a significant controlling of tumor growth, Dr. Brekken said. Importantly, the reduction in tumor size was predicted by the decrease in signal observed non-invasively with the targeted microbubbles.

"Ultrasound is a safe technology and most physicians have an ultrasound machine in their office," Dr. Brekken said. "In addition, this monitoring technology would neither require radiation nor the injection of toxic substances for imaging purposes.

"We are the first group to show that this technique can be used to monitor the effectiveness of an anti-cancer agent," he said.

The monitoring method developed by Dr. Brekken and his colleagues would need to obtain approval from the U.S. Food and Drug Administration before it could be used in humans. Microbubbles will have to be engineered for human patients and these microbubbles will need to be linked to anti-cancer agents using chemicals acceptable to the FDA for use in humans.

###

The research was supported by a grant from Peregrine Pharmaceuticals Inc, a biopharmaceutical company that has an exclusive license from the University of Texas System for the anti-VEGF agent that Dr. Brekken and other UT Southwestern researchers developed and are testing in several preclinical studies. Dr. Brekken also is a consultant to and has equity interest in the company.

Other UT Southwestern researchers contributing to the study included Juliet Carbon, a senior research associate at the Hamon Center; lead author Dr. Grzegorz "Greg" Korpanty, formerly a researcher at the Hamon Center and now a resident in internal medicine at Mater Misericordiae University Hospital in Dublin, Ireland; and Dr. Jason Fleming, former associate professor of surgery at UT Southwestern and now a surgical oncologist at the University of Texas M.D. Anderson Cancer Center. A researcher from Baylor University Medical Center in Dallas also participated.

About UT Southwestern Medical Center

UT Southwestern Medical Center, one of the premier medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. Its more than 1,400 full-time faculty members - including four active Nobel Prize winners, more than any other medical school in the world - are responsible for groundbreaking medical advances and are committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in 40 specialties to nearly 89,000 hospitalized patients and oversee 2.1 million outpatient visits a year.

The UT Southwestern Harold C. Simmons Comprehensive Cancer Center combines the highest standards of individual care with innovative programs for cancer diagnosis, treatment and prevention based on UT Southwestern's internationally recognized research coupled with the most sophisticated equipment and advanced technologies available. The expertise of the physicians in the Simmons Cancer Center extends to virtually every cancer in every age group, from breast, urologic, gynecologic, lung, gastrointestinal, head and neck, brain, and skin to lymphomas, leukemia, and bone marrow transplantation.

Contact: Toni Heinzl
UT Southwestern Medical Center

Turning Green Gunk To Anti-Cancer Gold

2007-04-16T10:28:00.001-07:00

Combining synthetic chemistry techniques with a knowledge of the properties and actions of enzymes, scientists have been able to produce an exciting class of anti-cancer drugs originally isolated from blue-green algae.

This accomplishment is expected to make it possible to produce enough of the promising drugs for use in clinical trials.

In a study featured on the cover of the January issue of the journal ACS Chemical Biology, a scientific team lead by University of Michigan Life Sciences Institute Research Professor David H. Sherman and researcher Zachary Q. Beck found the trick to turning the green gunk into gold - cancer fighting gold.

"It was simply too difficult to use the native blue-green algae for high-level production using traditional fermentation approaches," said Sherman. But the compound, called cryptophycin 1, held so much promise as an anti-cancer drug that organic chemists got busy trying to find ways to make a synthetic form of the compound in large enough quantities for clinical trials.

Developing an efficient synthetic route to natural product compounds and their analogs is often an essential step in drug development. With drugs such as penicillin and tetracycline, it can easily be done, but cryptophycins present more of a challenge. Sherman's team realized that with all cryptophycins, the most difficult step came very late in the synthesis, at the point at which a key part called an epoxide - a highly strained, three-membered ring oxygen-containing group, crucial for the drug's anti-cancer activity - becomes attached to the molecule.

The epoxide group can be attached in two configurations, designated as alpha and beta. Scientists have known for several years that the beta configuration was absolutely required for the anti-cancer properties of the drug, but were unable to devise efficient synthetic strategies that favored that configuration.

Sherman's team accomplished this by isolating the entire set of biosynthetic genes and key enzymes and developing a new, efficient method to manufacture the broad class of cryptophycin natural products, including important analogs with clinical potential. This included characterization of an enzyme, cytochrome P450, that always introduces the epoxide in the desired beta configuration.

Sherman, who is also the John G. Searle Professor of Medicinal Chemistry in the College of Pharmacy, believes that this approach will allow effective new cryptophycin analogs with low levels of side effects to be created for clinical trials.

"This issue represented an exciting target that offered not only an interesting scientific problem, but the potential to do something of practical importance in creating a promising anti-cancer drug," he said.

"Biosynthetic Characterization and Chemoenzymatic Assembly of the Cryptophycins. Potent Anticancer Agents from Nostoc Cyanobionts" by Magarvey N. A.; Beck Z. Q.; Golakoti T. ; Ding Y. ; Huber U. ; Hemscheidt T. K.; Abelson D. ; Moore R. E.; Sherman D. H. appeared online Dec.15 and is the cover story in the print version of ACS Chemical Biology January, 2007.

Related Links:

ACS chemical biology

U-M Life Sciences institute

Contact: Robin Stephenson
University of Michigan

Homing Nanoparticles Pack Multiple Assault On Tumors

2007-04-16T10:11:00.000-07:00

A collaborative team led by Erkki Ruoslahti, M.D., Ph.D., of the Burnham Institute for Medical Research at UC Santa Barbara (Burnham) has developed nanoparticles that seek out tumors and bind to their blood vessels, and then attract more nanoparticles to the tumor target. Using this system the team demonstrated that the homing nanoparticle could be used to deliver a "payload" of an imaging compound, and in the process act as a clotting agent, obstructing as much as 20% of the tumor blood vessels. These findings are pending publication in the Proceedings of the National Academy of Sciences and will be made available at the journal's website during the week of January 8, 2007.

The promise of nanomedicine is based on the fact that a particle can perform more functions than a drug. Multifuncionality is demonstrated in the current study, in which researchers from Burnham, UC San Diego, and Massachusetts Institute of Technology designed a nanoparticle that combined tumor-homing, self-amplification of the homing, obstructing tumor blood flow, and imaging.

Using a screening technique developed previously in Ruoslahti's laboratory, the group identified a peptide that homed to the blood vessels, or vasculature, inside breast cancer tumors growing in mice. The peptide was comprised of five amino acids: Cysteine-Arginine-Glutamic acid-Lysine-Alanine, abbreviated CREKA.

The researchers then demonstrated that the CREKA peptide recognizes clotted blood, which is present in the lining of tumor vessels but not in vessels of normal tissues. They used a special mouse strain that lacks fibrinogen, the main protein component of blood clots, to show this: tumors growing in these fibrinogen-deficient mice did not attract the CREKA peptide, whereas the peptide was detected in the tumors of a control group of normal littermates.

Having confirmed clotted blood as the binding site for CREKA, the team constructed nanoparticles from superparamagnetic amino dextran-coated iron oxide (SPIO); such particles are used in the clinic to enhance MRI imaging. They coupled the CREKA peptide to the SPIO particles to give the particles a tumor-homing function and programmed an additional enhanced imaging functionality into their nanoparticle by making it fluorescent.

Initially, CREKA-SPIO's tumor homing ability was impeded by a natural defense response, which activates the reticuloendothelial system (RES)--white blood cells which together with the liver and spleen comprise a protective screening network in mice (and humans). The investigators devised "decoy" molecules of liposomes coated with nickel, which diverted the RES response that would have otherwise been directed toward CREKA-SPIO. The use of decoy molecules extended the half-life of CREKA-SPIO in circulating blood five-fold, which greatly increased the nanoparticle's ability to home to tumors.

The CREKA-SPIO that accumulated in the tumor enhanced blood clotting in tumor vessels, creating additional binding sites for the nanoparticles. This "self amplification" of the tumor homing greatly enhanced the investigators' ability to image the tumors. It also contributed to blocking as much as 20% of the blood vessels in the tumor. While occluding 20% of tumor vessels was not sufficient to reduce the rate of tumor growth, it is a promising target for future studies.

"Having identified the principle of self-amplification, we are now optimizing the process, hoping to obtain a more complete shut-down of blood flow into the tumor to strangle it," says Ruoslahti. "We are also in the process of adding a drug delivery function to the particles. These two approaches are synergistic; the more particles we bring into the tumor, the greater the obstruction of the blood flow and more of the drug is delivered into the tumor."

###

Co-authors on this publication include: Dimitri Simberg, Tasmia Duza, Markus Essler, Jan Pilch, Lianglin Zhang, Austin Derfus, contributing from Dr. Erkki Ruoslahti's laboratories at Burnham Institute for Medical Research and Burnham Institute for Medical Research at UC Santa Barbara; Michael Sailor, Ji Ho Park, Austin Derfus, and Robert Hoffman, from University of California, San Diego; Sangeeta Bhatia, from Massachusetts Institute of Technology; and Meng Yang and Robert Hoffman from AntiCancer, Inc., San Diego, California.

This work was supported with funding from the National Institutes of Health.

Dr. Erkki Ruoslahti is Distinguished Professor and former President and CEO at Burnham. He recently founded the "Vascular Mapping Center" at Burnham-UC Santa Barbara, which aims at developing applications for vascular "zip codes, molecular signatures in blood and lymphatic vessels ("vasculature") that are specific to individual tissues and disease sites.

Burnham-UCSB, was established in 2006 through a collaborative effort of the Burnham Institute for Medical Research, based in La Jolla, California, and the University of California at Santa Barbara.

Burnham Institute for Medical Research is an independent non-profit research institution dedicated to advancing the frontiers of scientific knowledge in the life sciences and medicine, and providing the foundation for tomorrow's innovative therapies. The Institute is home to three major centers: the National Cancer Institute-designated Cancer Center, the Del E. Webb Center for Neuroscience and Aging Research, and the Infectious and Inflammatory Disease Center. Established in 1976 in La Jolla, California, Burnham today employs over 750 people and ranks consistently among the world's top 20 research institutes in independent surveys conducted by the Institute for Scientific Information. Burnham recently announced plans to open a campus in Orlando, Florida that will extend the Institute's capabilities in drug discovery and genomics, as well as expand its research to cover more types of diseases. For additional information about Burnham and to learn about ways to support its research, visit http://www.burnham.org/.

Contact: Nancy Beddingfield
Burnham Institute

Jefferson Scientists Find Guardian Gene's Choices Crucial To Stopping Cancer Process

2007-04-16T09:18:00.001-07:00

Scientists at the Kimmel Cancer Center at Thomas Jefferson University in Philadelphia have uncovered a novel pathway by which the anti-cancer gene p53 springs into action, protecting a damaged cell from becoming cancer. The gene can either halt the cell's growth or send it spiraling toward certain death. How this choice is made, the researchers say, could have implications for future strategies in chemotherapy drug development.

According to Steven McMahon, Ph.D., associate professor of cancer biology at Jefferson Medical College, who led the work, the p53 gene's - or rather its protein's - ability to direct a damaged cell to either stop growing or commit suicide depends on turning on separate groups of target genes. He and his co-workers have found that after a cell's DNA is damaged, the p53 protein's ability to bind to the DNA can be affected. Two enzymes, hMOF and TIP60, can chemically alter an amino acid, lysine 120, at the binding site, in turn influencing p53's decision on which target genes to turn on. The alteration can short-circuit p53's ability to cause the damaged cell to commit suicide, though it can still stop cell growth, suggesting that this change may help explain a mechanism behind p53's choice. They report their findings in the journal Molecular Cell.

"It's been known that p53 can induce cell cycle arrest or apoptosis (programmed cell death) as a way of eliminating developing cancer cells in response to cell damage, but no one has known how the choice is made," says Dr. McMahon. "This work narrows how the decision is made."

The findings could have implications for future drug development strategies. "Most chemotherapy strategies are aimed at getting cancer cells to die," Dr. McMahon says. "Figuring out what pathways p53 uses to cause that versus cell cycle arrest is important. It looks like this new modification that we have identified helps p53 make that decision."

"p53 is such an important player in the cancerous process - it's nearly always mutated or inactivated in cancer - that continuing to understand more about how it works will likely have significant implications for cancer research," says Dr. McMahon. "We wouldlike to understand the interplay between this newly identified pathway and others involved in p53 and cancer.

"Since p53 can make this decision, this might give some insight into which function of p53 is more important in which tissues," says co-author Stephen Sykes, a Ph.D. candidate at the University of Pennsylvania. "For example, K120 (lysine 120) mutations cause tumors in the prostate, but are not so much involved in causing immune system cancers such as lymphomas. That could suggest that p53's potential to cause cell death could be more important in certain tissues than in others. In the future, if someone could develop therapies that could specifically activate p53's potential to drive programmed cell death versus the cell cycle arrest potential, it might influence how a doctor might choose to treat a certain type of cancer.

"This may potentially enable the development of a cancer drug that would stimulate the enzymes to promote this modification driving p53 to apoptosis."

###

Contact: Steve Benowitz
Thomas Jefferson University

The Prognostic Significance Of Perineural Invasion In Prostatic Cancer Biopsies

2007-04-16T09:07:00.001-07:00

UroToday.com- Whether perineural invasion (PNI) identified in prostate cancer (CaP) biopsies is associated with disease recurrence is unclear from the literature. In an attempt to resolve this uncertainty, a systematic review was performed by Dr. Patricia Hamden and colleagues in the UK and published in the online edition of Cancer. What they found was that variable study design, execution and reporting excluded a definitive meta-analysis, but evidence suggests that PNI in biopsies was a significant prognostic indicator.

The authors' strategy used 128 search terms to identify articles published between 1990 and 2005. A total of 41,295 titles were reviewed by at least 2 reviewers and 128 articles identified for close evaluation. Ultimately, 10 surgical and 11 radiotherapy articles on PNI in biopsies as it related to patient outcomes were used in the report. Data items specific to biopsy PNI in CaP included biopsy procedure (amount of cores, number of nerves present and identification of PNI), histological slide preparation and pathological interpretation (consistency of identification, inclusion of information if no nerves were present).

No study reported on all data items and incomplete items ranged from 18% to 61% with a median of 39%. Exclusion criteria were variable, but included a history of prior treatment, unavailability of biopsies for review or the failure to obtain at least 4 biopsies. Only 1 surgical and 1 radiotherapy article was prospective. In surgical patients details on nerve sparing was generally lacking. In 12 studies, biopsies were reviewed for the presence of PNI and in 1 study 60% of biopsies were reviewed for this. In 5 studies the slides were not reviewed but the diagnosis was taken from the original report and in 3 articles the information was not provided. Only 2 articles reported blinded pathologic review. Individual patient data was sufficient in 5 articles to permit reanalysis.

The proportion of patients with PNI varied between 7% and 12% (median 9%) when the diagnosis was obtained form the original report and between 7% and 43% (median 23%) when slides were reviewed to identify PNI. Most studies had short (<6 months) of clinical follow-up. Overall, 6 of 10 surgical and 5 of 11 radiotherapy studies identified PNI as a prognostic factor in univariate analysis. Surgical articles that included a larger number of patients with less patient exclusion reported that PNI was independently prognostic in multivariate analysis with PSA and biopsy Gleason score. More than two-thirds of external radiotherapy studies but no brachytherapy study showed prognostic significance for perineural invasion. The highest incidence of PNI was found in locally-advanced disease.

Surprising to the authors were that none of the articles considered that the presence of nerves in the biopsies was a prerequisite for patient inclusion and no article provided data on the reproducibility of the PNI diagnosis. The authors conclude that the importance of PNI was likely to have been underestimated by the inclusion of uninformative test results (biopsies with no nerves in the specimens) and that despite this, the majority of studies including those performing multivariate analysis found prognostic significance to PNI. The weight of evidence supports PNI as of prognostic significance.

Patricia Harnden, Michael D. Shelley, Hayley Clements, Bernadette Coles, R. Sandy Tyndale-Biscoe, Brian Naylor, Malcolm D. Mason

Cancer 2006
Published Online: 22 Nov 2006
вЂЁDOI: 10.1002/cncr.22388

Reviewed by UroToday.com Contributing Editor Christopher P. Evans, M.D.

UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.

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Cell Therapeutics, Inc. (CTI) Files For Special Protocol Assessment (SPA) With FDA For XYOTAX Lung Cancer Trial In Women

2007-04-16T08:16:00.001-07:00

Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) today announced it has filed for a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for the design of its phase III trial of XYOTAX for women with advanced lung cancer. The trial, PGT306, will focus exclusively on women with normal estrogen levels, the subset where XYOTAX demonstrated the greatest survival advantage in the STELLAR trials. The trial is expected to enroll 300 poor performance status (PS2) women who have advanced stage non-small cell lung cancer (NSCLC) and have not received prior chemotherapy. Only women with normal estrogen levels either as a result of pre-menopausal age or hormone replacement therapy will be randomized in the follow-on study to the PIONEER trial.

"Through our clinical studies in 2006, we have gained important insights into the best lung cancer patient population to target our XYOTAX pivotal trial effort in order to minimize end-of-trial surprises while maximizing the probability of success. We look forward to feedback and guidance from the FDA on our phase III trial," said James A. Bianco, M.D., President and CEO of CTI. "Lung cancer continues to be the number one cancer killer of women. Better treatments are needed to combat this disease that will kill more than 70,000 women this year."

In addition, Bianco reviewed CTI accomplishments for 2006 and identified important Company milestones for 2007:

-- "In 2006 the Company made significant progress in positioning XYOTAX, if approved, for successful commercialization," said Bianco. "A major development was the establishment of a potential $285 million commercial and development partnership for XYOTAX with Novartis, providing the global expertise and resources of one of the leading multi-national oncology companies."

-- In addition the Company received positive advice and agreement from the EMEA's Scientific Advice Working Party (SAWP) to switch from the superiority endpoint in the STELLAR 4 trial to a non-inferiority endpoint for XYOTAX. CTI plans to file a marketing authorization application (MAA) in Europe in 2007 for XYOTAX as a single agent for first-line treatment of non-small cell lung cancer (NSCLC) in men and women PS2 patients. "Given the recent article in the Journal of the National Cancer Institute showing the economic toll of the hours lost to cancer care, we believe the SAWP agreement recognizes this important and often overlooked reality," said Bianco.

"For our other phase III product, pixantrone, we recently presented positive clinical data at the American Society of Hematology (ASH) meeting showing high overall responses from two pixantrone studies. In addition, based on interim data from the first 40 patients on the EXTEND trial, a randomized phase III study of pixantrone for patients with aggressive non-Hodgkin's lymphoma (NHL), the Data Monitoring Committee recommended the study continue," Bianco added.

"2006 was a rebuilding year for the Company, establishing an important partnership while advancing our two lead drug candidates toward market. With two key regulatory events for XYOTAX and pixantrone, 2007 promises to be a pivotal transition for the Company and its products."

Key Target Milestones for 2007

-- Reach Special Protocol Assessment agreement with FDA on PGT306 pivotal trial for XYOTAX in women with lung cancer and initiate enrollment at approximately 200 centers worldwide

-- Reach Special Protocol Assessment agreement with FDA on PIX303 pivotal trial for pixantrone in first-line and second-line indolent NHL and initiate enrollment at more than 100 centers worldwide

-- File a marketing authorization application (MAA) in Europe in 2007 for XYOTAX as a single agent for first-line treatment of non-small cell lung cancer (NSCLC) in PS2 patients

-- Conduct interim analysis on phase III pixantrone clinical trial in relapsed aggressive NHL (EXTEND trial) and if compelling, meet with FDA to discuss potential registration strategy

-- Maintain burn rate at 2006 level, continue to strengthen and de-leverage balance sheet

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.cticseattle.com/.

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of XYOTAX and pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with XYOTAX and pixantrone in particular including, without limitation, the potential failure of XYOTAX and pixantrone to prove safe and effective for treatment of non -small cell lung cancer and non-Hodgkin's lymphoma, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling XYOTAX and pixantrone, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by Italian law, CTI is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward- looking statements whether as a result of new information, future events, or otherwise.

Cell Therapeutics, Inc.
http://www.cticseattle.com/

Texas Legislature To Consider Requiring Gardasil For Sixth Grade Girls, New Hampshire Begins To Distribute Gardasil

2007-04-16T07:10:00.001-07:00

The Texas Legislature in the new session that begins on Tuesday will consider two bills (SB 110, HB 215) that would require girls entering the sixth grade to receive Merck's human papillomavirus vaccine Gardasil, KENS 5 Eyewitness News/San Antonio Express-News reports (Rigby, KENS 5 Eyewitness News/San Antonio Express-News, 1/4). Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. FDA in July 2006 approved the vaccine for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine (Kaiser Daily Women's Health Policy Report, 1/5). The measure would allow parents to apply for an exemption if they do not want their daughters to receive Gardasil. State Sen. Leticia Van de Putte (D) plans to sponsor the Senate version of the measure, and state Rep. Jessica Farrar (D) plans to sponsor the legislation in the House (KENS 5 Eyewitness News/San Antonio Express-News, 1/4).

New Hampshire To Begin Distributing Gardasil to Physicians
New Hampshire this week plans to begin distributing Gardasil to doctors in the state as part of a plan to provide Gardasil at no cost to some girls as part of a state program that offers immunizations to minors, the Concord Monitor reports (Sanger-Katz, Concord Monitor, 1/7). New Hampshire's program, announced in November 2006 by the state Department of Health and Human Services, plans to provide the vaccine to girls and women ages 11 to 18. The program, which is funded by the federal government and private insurers, has budgeted $4.8 million for Gardasil and is scheduled to begin immunizations this month. Insurance companies will pay about $3.6 million, or 75% of the estimated cost of the program. The state health department estimates that about 17,000 girls will receive Gardasil next year, which is about 25% of those eligible (Kaiser Daily Women's Health Policy Report, 12/1/06). According to the Monitor, some doctors in the state have waiting lists of patients who want to receive Gardasil. Some doctors will offer the vaccine on a first-come, first-serve basis and others will honor waiting lists. State officials said there will not be a long-term shortage of the vaccine. "Because it's such a new vaccine, that's one of the challenges we have, is balancing what the need is with what the uptake will be," Mary Ann Cooney, the state's public health director, said, adding, "We don't want to purchase too much and have it go to waste" (Concord Monitor, 1/7).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Tumor-Suppressor Gene Critical For Placenta Development

2007-04-16T07:05:00.001-07:00

An important cancer-related gene may play a critical role in the development of the placenta, the organ that controls nutrient and oxygen exchange between a mother and her fetus during pregnancy, and perhaps in miscarriages.

Those conclusions come from a new study of the retinoblastoma (Rb) gene in mice. In humans, this gene, when mutated, raises the risk of a rare cancer of the eye called retinoblastoma. Two decades ago, it was identified as the first tumor-suppressor gene, a class of genes that protects cells from becoming cancerous. It has since been shown to be inactivated in many cancers.

In this study, researchers shut off the Rb gene in stem cells that give rise to most of the placenta, resulting in an abnormal placenta and death of the embryos.

The findings provide new insights into development of the placenta and into how the Rb gene blocks tumor growth.

They also raise the possibility that this important tumor-suppressor gene might play a role in miscarriages.

The study, led by researchers at the Ohio State University Comprehensive Cancer Center, is published in the January 2007 issue of the journal Genes and Development.

"Our findings strongly suggest that the Rb gene is important in the development of the placenta, but they have other important implications, as well," says principal investigator Gustavo Leone, assistant professor of molecular virology, immunology and medical genetics and a researcher with Ohio State's Comprehensive Cancer Center and human cancer genetics program.

"People born with one mutated Rb gene have a higher risk of developing retinoblastoma. But are they also predisposed to miscarriage? Do Rb-related defects in the placenta cause learning or physical abnormalities? We are investigating these questions now."

Scientists know that the protein encoded by the Rb gene, the Rb protein, plays an important role in regulating how cells grow. But exactly how it does this - the molecule interacts with 110 other proteins - remains unknown.

In 2003, Leone and a group of collaborators discovered that loss of the Rb gene caused abnormalities in the placenta, especially where it contacts the uterus. They published that research in the journal Nature.

"This was the first evidence that Rb had an important role in the placenta," says Pamela Wenzel, a graduate student in Leone's laboratory and first author of the new paper.

For this study, Wenzel developed a transgenic mouse that makes an enzyme that deletes DNA. Specifically, it removes the DNA that lies between two gene markers. She then used a second transgenic mouse in which the gene markers were placed in the Rb gene.

When she crossed the two strains of mice, the resulting embryos had the DNA-destroying enzyme and the gene markers in their placenta stem cells. The enzyme removed the DNA between the two markers, leaving the embryos without a working Rb gene in the placental progenitor cells.

These stem cells divided far too often. They gave rise to too many cells and formed a defective placenta, especially where the placenta interacts with the uterus.

These embryos died about 15 days after fertilization, a time at which placenta function becomes critical for survival (the gestation period for mice is 19 days).

Interestingly, the researchers also produced some mice in which the Rb gene was present in the placenta stem cells but destroyed in cells produced by them. These cells formed a normal-looking placenta and the embryos survived.

"This suggests that Rb is important in maintaining placental stems cells, and that it plays a smaller or different role in the cells they give rise to," Leone says.

Lastly, the researchers produced transgenic mice that lacked both the Rb gene and a second gene, E2f3. The Rb protein normally couples with, or binds to, the protein encoded by the E2f3 gene. Embryos missing both genes lived three days longer than the embryos missing Rb only, but all died before birth.

"This showed that the interaction of these two proteins is definitely important," Leone says. "It strongly suggests that E2f3 is a key player in mediating Rb function in stem cells and possibly in its role as a tumor suppressor."

Next, Leone and his colleagues want to know if the Rb gene is important in miscarriages.

"Miscarriages have never been linked to a gene defect, but understanding the genetic basis of miscarriage would be a hugely important," Leone says. "It would be the first link between a gene mutation, placental function and development."

Funding from the National Cancer Institute, the National Science Foundation, the Pew Charitable Trust and the Leukemia & Lymphoma Society supported this research.

###

Contact: Darrell E. Ward
Ohio State University

Pancreatic Cancer Surgery Five-Year Survivors 65 And Up Live Nearly As Long As Anyone

2007-04-16T06:16:00.001-07:00

A new study shows that pancreatic cancer patients 65 or older who live at least five years after surgery have nearly as good a chance as anyone else to live another five years.

Researchers at the Kimmel Cancer Center at Thomas Jefferson University and Thomas Jefferson University Hospital in Philadelphia reviewed the records of 890 patients with pancreatic cancer who underwent the standard pancreaticoduodenectomy, or Whipple procedure, which entails the removal of the gallbladder, common bile duct, part of the duodenum, and the head of the pancreas, between 1970 and 1999 at Johns Hopkins University. They identified those who lived for five years, and compared those who lived for at least an additional five years to the "actuarial" - or estimated - survival of the general population beginning at age 70.

Reporting in the journal Surgery, they found that 201 patients (23 percent) lived five years after surgery, at least half of whom were 65 years old or older at the time of surgery. Of those five-year survivors, an estimated 65 percent lived at least an additional five years. In the general population, roughly 87 percent of the same age group live another five years.

The study has an important message, says Charles Yeo, M.D., Samuel Gross Professor and Chair of Surgery at Jefferson Medical College, who led the work. "A decade ago, many clinicians thought that there was little reason to operate on patients with pancreatic ductal cancer, that surgery does little to extend life and improve the quality of life," says Dr. Yeo. "Not too long ago, few lived for five years after diagnosis. Today that's not true. There's been a paradigm shift in the way we treat and think about this disease."

While only approximately 25 percent of those diagnosed with pancreatic cancer who undergo successful surgical "resection" of their disease live at least five years, overall, of those who live for five years after resection, some 55 percent will be alive at least another five years.

"The public hears 'pancreatic cancer' and thinks there's little hope and there isn't much to do. The good news is, with new imaging techniques, better early detection, improved screening of high-risk groups, and new therapies on the horizon, we're actually making great progress when it comes to pancreatic cancer. It's no longer a death sentence."

Pancreatic cancer, the fifth-leading cause of cancer death in this country, takes some 30,000 lives a year. It remains one of the deadliest cancers; only approximately 5 percent of all those with pancreatic cancer live one year after diagnosis, and only 1 percent are alive five years later.

Contact: Steve Benowitz
Thomas Jefferson University

Genetic Factors Associated With Head And Neck Cancer Examined By Study

2007-04-16T06:07:00.001-07:00

Preliminary research indicates that several specific genetic alterations are associated with the development of smoking-related head and neck skin cancers, according to a report in the January 10 issue of JAMA.

Despite its slowly declining incidence rate and a modest improvement in 5-year survival, squamous cell carcinoma (SCC; a type of cancer similar to the common form of skin cancer) of the head and neck continues to be a clinical challenge. With a worldwide prevalence of more than 1.6 million, it is estimated that in 2006, about 30,990 new cases will be diagnosed in the United States. Even with the use of modern therapeutic options that include surgery, radiation therapy, and chemotherapeutic intervention, 50 percent of all patients will ultimately die of this disease, with more than 7,400 deaths projected for 2006 in the United States, according to background information in the article.

Charis Eng, M.D., Ph.D., of the Genomic Medicine Institute at the Cleveland Clinic Foundation, Cleveland, and colleagues conducted a study to determine the extent of genomic alterations in the stroma (connective tissue) of head and neck SCC. Tumor epithelium (the cancer itself) and surrounding stroma were isolated from 122 patients with oral cavity and oropharyngeal (relating to the mouth and pharynx) or hypopharyngeal (bottom part of throat) SCC and these tissues were subjected to whole genome analysis.

Tumor-associated stroma of head and neck SCC from smokers were found to have a high degree of genomic alterations. A correlation between tumor aggressiveness could be found for a specific set of 5 loci. Three stroma-specific loci were associated with tumor size and regional nodal (small mass) metastases. Also, 2 specific genomic alterations (markers termed "hot spots") were positively correlated with node metastases and clinical stage.

"Stroma-specific genetic alterations are associated with smoking-related head and neck SCC genesis," the authors write. "We hope that our genomic observations, which point to genomic regions that may harbor many genes, will guide future in-depth functional and mechanistic studies. Nevertheless, our current observations can be used to identify new biomarkers for prediction of clinical outcome and potentially novel compartments for targeted therapy and prevention."

###

(JAMA. 2007;297:187-195)

This study was funded in part by a grant from the state of Ohio and the Doris Duke Distinguished Clinical Scientist Award. Cleveland Clinic Innovations has submitted a provisional patent application based on these observations. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Contact: Molly Johnson
JAMA and Archives Journals

Black Women Of Faith And Medicine: Working Together To Eradicate Cervical Cancer

2007-04-16T03:39:00.001-07:00

100% Preventable. Spread the Word. Save a Sister. This is the new public education campaign message from the Balm In Gilead's 2007 ISIS Project (Intimate Sessions for Informed Sexuality). National Spokesperson Estelle H. Whitney, MD; Anafidelia Tavares, MD, MPH along with 20 African-American female clinicians came together at a press conference today at the Four Seasons Hotel to support the campaign and to announce the Balm In Gilead's new component of the ISIS Project: Black Women of Faith and Medicine: Working Together to Eradicate Cervical Cancer. The Balm In Gilead also announced its new public education program for this year's ISIS Project, the goal of which is to inform and educate African-American women about cervical cancer and to encourage them to take the HPV test and to become knowledgeable about the HPV vaccine. The ISIS Project encourages African-American women between the ages of 30 and 70 years old to become empowered to safeguard their health by learning about HPV, cervical cancer and the need for regular screening with the Pap test and HPV test.

The medical data speaks for itself:

-- African-American women are at least 50% more likely to die from cervical cancer than white women.

-- Cervical cancer is caused by persistent infection with an extremely common and contagious virus, the human papillomavirus (HPV); although there are approximately 15 cancer-causing HPV types, types 16 and 18 are responsible for 70% of all cervical cancers worldwide.

-- Many women are not aware that cervical cancer is preventable and that new technologies like the HPV test are an important weapon in the fight against cervical cancer.

-- African-American women are not aware of the vaccine against the disease that is available for women under 26 years of age.

-- Almost one third of all women in the U.S. had no health insurance in 2005, and some cannot pay for routine screenings like Pap tests or the HPV test or the now available vaccine.

-- New technologies including HPV testing for screening women and HPV vaccination for girls offer new opportunities to prevent cervical cancer among African-American women.

The ISIS Project was initially launched in March 2005 with the partnership of the women's societies of three major African-American religious denominations (African Methodist Episcopal, African Methodist Episcopal Zion, and Christian Methodist Episcopal) with a potential reach of 7 million African-Americans. "The addition of the expertise of African American female clinicians to the ISIS Project makes it a complete program that targets the heart and soul of Black women across our nation," states Pernessa Seele, Founder/CEO of the Balm In Gilead. She further states, "Due to the centrality of the church in African-American life, this program will be able to reach those who frequently under use cancer screening services and the underinsured."

Ten markets across the country will benefit from educational training program on cervical cancer -- The District of Columbia, Miami, Houston, Montgomery, Oakland, Chicago, Greensboro, St. Louis, Greenville and Pittsburgh.

Estelle H. Whitney, MD specializes in Obstetrics & Gynecology in Newark, Delaware. She is a graduate of the Howard University School of Medicine. Anafidelia Tavares, MD, MPH is Director of Women's Health at the Balm In Gilead, where she oversees the ISIS Project. She received her medical degree at the Boston University School of Medicine and completed a Masters of Public Health at the Harvard School of Public Health.

The ISIS Project will employ a peer educator strategy in each city. Drs. Whitney and Tavares will conduct 2-day training sessions with 15 women recruited to become peer educators per market. These trainees will become Balm In Gilead Certified Cervical Cancer Peer Educators. After the training sessions, the peer educators will go into the community and deliver five educational sessions within a six month period. These sessions will include information on HPV and cervical cancer, screenings and available vaccines, and how to discuss these issues with health care professionals (role playing scenarios will be used). Grass roots marketing materials (church event listings, flyers, pamphlets and other handouts) will be utilized to solicit community participants to attend the sessions.

In addition, the 20 African-American clinicians will serve as expert media spokespersons in their respective markets regarding the overall medical issues of cervical cancer.

With the launch of the ISIS project in 2005, the Balm In Gilead is dedicated to educating women about cervical cancer and empowering them to get their annual Pap test and HPV test if they are over 30 years of age. The campaign also wants women to become knowledgeable about the vaccine.

The Balm In Gilead is a not-for-profit, non-governmental organization whose mission is to improve the health status of people of the African Diaspora by building the capacity of faith communities to address life- threatening diseases, especially HIV/AIDS.

Over the past 18 years, The Balm In Gilead has earned worldwide recognition as the leading organization in the United States dedicated to empowering and mobilizing faith institutions to address life-threatening diseases, especially HIV/AIDS within the African-American community and on the continent of Africa.

For additional information about the Balm In Gilead, visit our website at http://www.balmingilead.org.

Support for the ISIS Project is made possible through an unrestricted educational grant from Digene and Merck Corporations.

The ISIS Project
http://www.balmingilead.org

High-Power MRI Helps Mayo Clinic Surgical Team Predict Outcomes In Unusual Tumor Cases

2007-04-16T03:34:00.001-07:00

A Mayo Clinic surgical team has found that using a 3-Tesla MRI in surgical decision making provides a new level of capability to predict surgical outcomes that improves patient care by minimizing the potential for unsuccessful tumor-removal surgeries. The Mayo Clinic report appears in the December issue of the Journal of Neurosurgery.

In their report, Mayo physicians describe a case study of five patients. Four had neurofibromatosis, a condition with a predisposition to nerve-related tumors. All patients suffered from growths called "sciatic notch dumbbell- shaped" tumors. The tumors were benign, but resulted in neurologic dysfunction and disabling pain.

"In the past, if surgeons couldn't tell prior to surgery where the exact location of the large tumor was in relation to the sciatic nerve, it meant they couldn't predict in which cases surgery could be performed safely," explains Robert Spinner, M.D., the lead neurosurgeon on the Mayo Clinic team.

The team used an advanced magnetic resonance imaging (MRI) system performed on a 3-Tesla magnet to help identify suitable candidates for a difficult tumor-removal surgery. A Tesla is a unit of magnet strength. A 3- Tesla is one of the strongest commercially available.

Significance of the Mayo Clinic Case Study

A standardized surgical approach for safe and complete removal of sciatic notch dumbbell-shaped tumors has been problematic for at least three reasons. These tumors are:

-- relatively rare and therefore hard to study

-- anatomically difficult to reach and remove without injuring the main sciatic nerve

-- difficult to visualize before surgery with enough detail to distinguish tumor boundaries from nerve

The current Mayo Clinic report begins to change this situation by documenting a new multidisciplinary approach for obtaining the desired favorable surgical outcomes.

Surgeons need an accurate picture of how and whether they can remove a tumor while protecting a nerve. Otherwise, patients may be exposed to the risks of surgery without achieving surgical benefits if the tumor is inoperable because complete removal would damage a nerve. "Our experience demonstrates the advantages of predictive imaging at the outset," says Dr. Spinner. "With an integrated team of surgeons from three specialties, and an experienced radiologist specializing in advanced peripheral nerve imaging using the 3-Tesla MRI, we have devised an approach that minimizes unsuccessful tumor-removal surgeries."

About the Study

With the 3-Tesla MRI images, Mayo Clinic surgeons from three specialties - - neurosurgery, colorectal and orthopedic surgery -- obtained sufficiently detailed pictures of the tumor and nerve relationship before surgery in all five cases to accurately predict which patients would benefit from surgery. In three cases the tumor was predicted to be distinct from the main sciatic nerve, and the tumor was safely removed. All three patients experienced relief from pain and had no recurrent growth one year after surgery. In the other two cases, the tumor was predicted to be so entwined in the nerve that surgery would have damaged the nerve. Those patients did not undergo surgery.

Dr. Spinner said the team will continue to refine the approach to improve the care that these patients receive. "This new technology allows a multidisciplinary approach to be performed safely in these rare tumors that were once considered unresectable," he says. "In addition, the same techniques that we have developed have tremendous applications to many patients who have peripheral nerve tumors in more common locations."

Collaboration

Other members of the Mayo Clinic team included: Toshiki Endo, M.D.; Kimberly Amrami, M.D.; Eric Dozois, M.D.; Dusica Babovic-Vuksanovic, M.D.; and Franklin Sim, M.D.

To obtain the latest news releases from Mayo Clinic, go to http://www.mayoclinic.org/news. http://www.MayoClinic.com (http://www.mayoclinic.com) is available as a resource for your health stories.

Mayo Clinic
http://www.mayoclinic.com

Expanded Use For TheraSphere(R) Offers Physicians An Innovative Alternative To Traditional Liver Cancer Therapies

2007-04-16T02:49:00.001-07:00

MDS Nordion, a leading global provider of medical isotopes and radiopharmaceuticals used to diagnose and treat disease, announced today that the U.S. Food and Drug Administration has approved the use of TheraSphere(R) to treat patients with hepatocellular carcinoma (HCC), who have partial or branch portal vein thrombosis (PVT) and have been identified as suitable candidates by their physicians. HCC is the most common form of primary liver cancer. Portal vein thrombosis is a blockage, by a blood clot, of the portal vein, which brings blood to the liver. TheraSphere(R) is the first medical device approved in the U.S. to treat primary liver cancer patients with this condition. This expanded use extends the current approval of TheraSphere(R) as a Humanitarian Use Device for the treatment of HCC.

Treating HCC patients who have PVT using traditional therapies is often difficult or impossible. Some treatments can slow or even stop blood flow altogether, potentially leading to complications for patients with this condition. Unlike conventional therapies, TheraSphere(R) has been demonstrated to not significantly alter blood flow to the liver and tumors. With this treatment, small radioactive glass beads attack cancerous tumors in the liver, while minimizing the impact on the patient's healthy tissue. It is injected by a physician into the main artery of the liver through a catheter which allows the treatment to be delivered directly to the tumor via blood vessels.

According to the American Cancer Society, approximately 18,500 cases of primary liver cancer were diagnosed in the United States in 2006. While the rate of people developing liver cancer has stabilized, the actual number of liver cancer patients continues to increase with an aging and growing population. Presently there are limited options available to treat the disease.

"We are excited about providing physicians with new tools to help in their ongoing fight against cancer," said Steve West, President of MDS Nordion. "This expanded use for TheraSphere(R) provides physicians with a new treatment option and hope for patients with primary liver cancer."

Today's announcement marks a progressive step toward expanding the use of TheraSphere(R). Last September, MDS Nordion announced that it had received FDA approval to move forward with clinical trials to test the effectiveness of TheraSphere(R) in patients with secondary liver cancer.

About TheraSphere

TheraSphere(R) is a low toxicity, out-patient liver cancer therapy which consists of millions of micro-glass beads containing radioactive yttrium-90. The product is injected by physicians into the main artery of the patient's liver through a catheter which allows the treatment to be delivered directly to the tumor via blood vessels. Unlike chemotherapy, it has few side effects. Patients rarely experience nausea and vomiting usually associated with high-dose, systemic chemotherapies. The TheraSphere(R) treatment can generally be administered on an outpatient basis and does not usually require an overnight hospital stay. TheraSphere(R), 100% reimbursed by Medicare and many commercial health insurers, is approved in the U.S. as a Humanitarian Device for the treatment of hepatocellular carcinoma, also referred to as primary liver cancer, and is now approved for patients who also have partial or branch portal vein thrombosis and who are identified as suitable candidates by their physicians. For more information on TheraSphere(R) go to http://www.therasphere.com or visit us at SIR 2007, March 1-6, 2007 in Seattle, Washington, Booth 1215.

About MDS Nordion

MDS Nordion (http://www.mds.nordion.com) is a world leader in medical isotopes, radiation and related technologies. It is a division of MDS Inc. (TSX:MDS)(NYSE:MDZ). MDS Inc. is a global life sciences company that provides market-leading products and services that our customers need for the development of drugs and diagnosis and treatment of disease. We are a leading global provider of pharmaceutical contract research, medical isotopes for molecular imaging, radiotherapeutics, and analytical instruments. MDS has more than 8,800 highly skilled people in 28 countries. Find out more at http://www.mdsinc.com or by calling 1-888-MDS-7222, 24 hours a day.

MDS Nordion
http://www.mds.nordion.com

Soy Compound May Fight Breast, Ovarian Cancers, Says Tulane Cancer Researcher

2007-04-16T02:37:00.001-07:00

A compound produced by specially grown soy beans may prove to be successful in fighting the growth of breast and ovarian cancers, says Tulane cancer researcher Matthew Burow.

Burow tested the compound, known as glyceollin, on mice with ovarian and breast cancer tumors that are stimulated by the hormone estrogen. Over time, the compound stopped further growth of the tumors by interfering with the tumor's ability to respond to estrogen. According to Burow, the finding is significant because of the lack of effective therapies available to women with advanced breast or ovarian cancer. Unlike some of the available therapies, the glyceollins did not stimulate uterine cancer growth.

The results of the research were published in the December 2006 issue of Clinical Cancer Research.

Burow has collaborated in the past with the United States Department of Agriculture and other institutions to fully understand the potential of glyceollins. In related research in primates, Burow's collaborators demonstrated that a diet rich in glyceollins also could help fight breast cancer.

Tulane University
Tulane University

Moffitt Named Melanoma Center Of Excellence

2007-04-16T01:48:00.001-07:00

H. Lee Moffitt Cancer Center & Research Institute's Cutaneous Oncology Program has been recognized as one of the first top ten Melanoma Centers of Excellence named by the Melanoma Hope Network. The network works to recognize melanoma treatment centers across the United States that offer exceptional care, knowledge and compassion to patients diagnosed with advanced melanoma.

В "We are particularly pleased to receive this designation because it recognizes the contributions and collaborations of all the members of the Cutaneous Program - dermatologists, pathologists, surgeons and medical and radiation oncologists - that have to work together in a Melanoma Center of Excellence," said Dr. Vernon Sondak, program leader of the Cutaneous Oncology Program. "We think this is just the beginning of what we can achieve as a group, and the better we work together the better it is for our melanoma patients and our patients with other skin cancers."

В The program's comprehensive care at Moffitt includes the latest investigational treatments for melanoma. Program physicians have been pioneers in developing and defining the role of lymphatic mapping and sentinel node biopsy for staging of patients with clinically negative nodes, as well as investigating adjuvant therapy for both node-negative and node-positive patients. Surgical treatment of selected patients with in-transit and metastatic melanoma also is a fundamental part of the approach to patients with more advanced disease.

В Moffitt continues to lead the way in melanoma treatment with the recruitment of Dr. Jeffrey Weber from the University of Southern California in Los Angeles.В The internationally-renowned melanoma medical oncologist, tumor immunologist and clinical and translational researcher will join the Cutaneous Oncology Program in June.В

В Also, the Cutaneous Oncology Clinic at Moffitt will expand and move to new quarters when the West Clinic expansion is complete.В The new facility, specifically designed to meet the needs of melanoma and skin cancer patients, is expected to open in February.

В Located in Tampa, Florida on the University of South Florida campus, H. Lee Moffitt Cancer Center & Research Institute is the only Florida-based cancer center with the NCI designation as a Comprehensive Cancer Center for its excellence in research and contributions to clinical trials, prevention and cancer control. Moffitt currently has 16 affiliates in Florida, one in Georgia and two in Puerto Rico. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country's leading cancer centers, and is listed in U.S. News & World Report as one of America's Best Hospitals for cancer. Moffitt's sole mission is to contribute to the prevention and cure of cancer.

В H. Lee Moffitt Cancer Center
& Research Institute
12902 Magnolia Dr., MBC-PR
Tampa, Florida 33612
http://www.moffitt.org

Washington, D.C., Council Members Propose Measure To Require Girls Entering Sixth Grade To Receive HPV Vaccination

2007-04-16T01:37:00.001-07:00

Washington, D.C., City Council Members Mary Cheh (D) and independent David Catania on Tuesday proposed a bill that would require girls entering the sixth grade to receive Merck's human papillomavirus vaccine Gardasil, the Washington Post reports (Stewart/Stein, Washington Post, 1/10). Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. FDA in July 2006 approved the vaccine for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine (Kaiser Daily Women's Health Policy Report, 1/9). According to the legislation, female students would be required to show proof of vaccination before enrolling in the sixth grade in District of Columbia Public Schools, unless their parent or legal guardian chose to "opt out" of the requirement. The bill does not specify the circumstances under which girls would be allowed an exemption. Catania said he is introducing the bill because federal funding is available so Medicaid beneficiaries and others who are uninsured or underinsured can be vaccinated at no cost. According to the Post, Catania also decided to propose the legislation in part because of the high cervical cancer incidence in the district, which the American Cancer Society reports is 13.5 cases per 100,000 females, compared with the national rate of 8.8 cases per 100,000 females. "With January being National Cervical Cancer Awareness Month, now is the perfect time for the [d]istrict to lead the nation in the fight against what is in essence a preventable disease," Catania said at the Council meeting. Stanley Gall of the American College of Obstetricians and Gynecologists said, "I think this makes perfect sense," adding, "There would certainly be a significant health benefit." Joseph Bocchini, chair of the American Academy of Pediatrics committee on infectious diseases, said, "I think it's too early. This is a new vaccine. It would be wise to wait until we have additional information about the safety of the vaccine." Iris Toyer, co-chair of Parents United for D.C. Public Schools, said whether to vaccinate girls with Gardasil is "really a decision between parents and doctors," adding that she understands the "intent" of the legislation, "but a lot of discussion must be done" (Washington Post, 1/10).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

South Dakota To Provide HPV Vaccine Gardasil At No Cost To Girls, Women Ages 11 To 18

2007-04-16T00:42:00.001-07:00

South Dakota Gov. Mike Rounds (R) on Monday said the state will provide Merck's human papillomavirus vaccine Gardasil at no cost to girls and women ages 11 to 18, the AP/Yankton Press & Dakotan reports (Brokaw, AP/Yankton Press & Dakotan, 1/8). Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. FDA in July 2006 approved the vaccine for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine (Kaiser Daily Women's Health Policy Report,1/9). The South Dakota Department of Health plans to purchase the vaccine using $1.7 million in state funds and $7.5 million in federal funds, state Health Secretary Doneen Hollingsworth said. State officials aim to provide Gardasil to physician offices and health department clinics by Jan. 22 for the roughly 44,000 girls in the state eligible to receive the vaccine, according to Hollingsworth. Physicians will be permitted to charge a fee for administering Gardasil but only to those who can afford it, the AP/Press & Dakotan reports. Hollingsworth said the voluntary vaccination program likely will focus on girls ages 11 and 12 in future years, adding that South Dakota will be the second state, after New Hampshire, to make the vaccine available at no cost (AP/Yankton Press & Dakotan, 1/8).

Reaction
According to the Yankton Press & Dakotan, legislators from the southeast region of the state in general support efforts to provide Gardasil at no cost. "Anybody who thinks, if you go out and get this vaccination, that you are promiscuous -- that is a misnomer," state Rep. Garry Moore (D) said, adding, "I don't think that's fair at all." According to Moore, providing the vaccine is a health, not a moral, issue. State Rep. Gary Jerke (R) said that he is concerned about the message being sent to young girls because HPV can be sexually transmitted. "It makes me nervous that we don't have a corresponding emphasis on abstinence or those things that would discourage" sexual activity, Jerke said, adding, "To me, this makes a statement that the state endorses that type of lifestyle, of sexual promiscuity" (Dockendorf, Yankton Press & Dakotan, 1/10). Rounds on Monday said that children still should be taught that abstinence is the best way to prevent sexually transmitted infections, according to the Argus Leader. "We've still got to be watching out for values," he said (Myers, Sioux Falls Argus Leader, 1/9).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Live 'Ask The Experts' Wednesday Will Address Implementation Of HPV Vaccine Gardasil

2007-04-16T00:35:00.001-07:00

As physicians begin to administer Merck's new human papillomavirus vaccine Gardasil, panelists on this "Ask the Experts" will focus on questions such as: What are the guidelines for who should get the vaccine and at what age? Who will pay for it? What is the best way to ensure access to the vaccine? Kaisernetwork.org Managing Editor Jill Braden Balderas will moderate the discussion with Anne Schuchat, director of CDC's National Center for Immunization and Respiratory Diseases; Renee Jenkins, professor and chair of the Howard University College of Medicine Department of Pediatrics and Child Health and president-elect of the American Academy of Pediatrics; and Alina Salganicoff, Kaiser Family Foundation vice president and director of women's health policy. Submit your questions in advance by e-mailing ask@kaisernetwork.org or by calling 1-888-KAISER8 (524-7378) during the scheduled showtime. The live webcast will begin online at 2 p.m. ET at kaisernetwork.org.

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Novel Regulation Of The Common Tumor Suppressor PTEN

2007-04-15T23:38:00.001-07:00

PTEN is one of the most commonly mutated tumor suppressor genes. It is an antagonist for many cellular growth, proliferation and survival processes. When mutated or deleted, it causes cancers of the prostate, breast, colon, and brain. Researchers led by scientists at Memorial Sloan-Kettering Cancer Center have now identified fundamentally novel regulatory mechanisms of PTEN function. The findings from two related studies are published in the January 12 issue of Cell.

The first is research by Dr. Xuejen Jiang's laboratory at Sloan-Kettering which identified a novel component that regulates PTEN. This protein, NEDD4-1, controls protein stability in cells. Researchers found that NEDD4-1 is a key component in eliminating PTEN from cells by adding a molecular tag, ubiquitin, to PTEN causing degradation in the cellular machinery called proteasome. In a mouse model for prostate cancer, the researchers found that areas with aggressive tumor contained low PTEN levels and high NEDD4-1. They concluded that NEDD4-1 could promote cancer development by down-regulating PTEN.

The second study by Dr. Pier Paolo Pandolfi of Memorial Sloan-Kettering and colleagues found that the ubiquitination of PTEN by NEDD4-1 also regulates another important aspect of PTEN, its cellular localization.

PTEN has been found mostly in the cytoplasm but has been known to also be in cell nuclei. While the cytoplasmic function of PTEN is now quite well understood, its nuclear functions have been elusive. Looking at a family with an inherited PTEN mutation that caused them to have the cancer-susceptibility condition, Cowden Syndrome, researchers found that the patients' colon cancer strikingly lacked nuclear PTEN.

The Pandolfi and Jiang labs showed that the PTEN mutation in these patients prevented the addition of ubiquitin by NEDD4-1, providing a molecular mechanism for the detrimental effect of the mutant PTEN protein. They showed that the single ubiquitin tagging is necessary to import PTEN into the cell nucleus where it is protected from degradation and cancer is initiated.

According to the researchers, the uncovered key role of PTEN degradation provides a new therapeutic strategy. Since ubiquitination has both positive (single tag) and negative (repetitive tagging) effects, a class of drugs, the proteasome inhibitors, that selectively blocks the degrading effects of ubiquitination, should now be studied as possible treatments for cancers with PTEN mutations.

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The research was supported by grants from The National Institutes of Health and the American Cancer Society.

Contact: Joanne Nicholas
Memorial Sloan-Kettering Cancer Center

Micro Molecules Can Identify Pancratic Cancer

2007-04-15T23:34:00.001-07:00

A pattern of micro molecules can distinguish pancreatic cancer from normal and benign pancreatic tissue, new research suggests.

The study examined human pancreatic tumor tissue and compared it to nearby normal tissue and control tissue for levels of microRNA (miRNA). It identified about 100 different miRNAs that are present usually at very high levels in the tumor tissue compared with their levels in normal pancreatic tissue.

The findings suggest that miRNAs form a signature, or expression pattern, that may offer new clues about how pancreatic cancer develops, and they could lead to new molecular markers that might improve doctors' ability to diagnose and treat the disease.

Pancreatic cancer is expected to strike 33,700 Americans and to kill 32,300 others this year, making it the fourth leading cause of cancer death. The high mortality rate - the number of new cases nearly equals the number of deaths - exists because the disease is difficult to diagnosis early and treatment advances have been few.

The study, led by cancer researchers at the Ohio State University Comprehensive Cancer Center, was published online in the International Journal of Cancer.

"Our findings show that a number of miRNAs are present at very different levels in pancreatic cancer compared with benign tissue from the same patient or with normal pancreatic tissue," says principal investigator Thomas D. Schmittgen, associate professor of pharmacy and a researcher with the Ohio State's Comprehensive Cancer Center.

"Most are present at much higher levels, which suggests that developing drugs to inhibit them might offer a new way to treat pancreatic cancer. It also means that a test based on miRNA levels might help diagnose pancreatic cancer."

miRNAs are extremely short molecules that were discovered about a dozen years ago and found to be important for controlling how proteins are made. Scientists have now identified more than 470 different miRNAs in humans. More recent research has shown that miRNAs also play an important role in cancer.

"A big problem we face with pancreatic cancer is an inability to detect tumors early," says Russell Postier, chairman of surgery at the University of Oklahoma Health Science Center and a co-author of the study.

"The exciting findings in our work indicate that there is a microRNA gene-expression pattern that is unique to pancreatic tumors, and this might be useful in diagnosing pancreatic cancer in the future."

For this study, the researchers used a technique developed by Schmittgen and a group of colleagues in 2004 to measure miRNA in small tissue samples. The method is based on a technology called real-time PCR profiling, which is highly sensitive and requires very small amounts of tissue, Schmittgen says.

The researchers used the method to compare the levels of 225 miRNAs in samples of pancreatic tumors from patients with adjacent normal tissue, normal pancreatic tissue and nine pancreatic cancer cell lines.

Computer analysis of the data identified a pattern of miRNAs that were present at increased or decreased levels in pancreatic tumor tissue compared with normal tissue. The analysis correctly identified 28 out of 28 pancreatic tumors, 11 of 15 adjacent benign tissues and six of six normal tissues.

Levels of some miRNAs were increased by more than 30- and 50-fold, with a few showing decreased levels of eight- to 15-fold.

Schmittgen and his colleagues are now working to learn which of the miRNAs they identified are most important for pancreatic cancer development, and if some are found only in pancreatic cancer and not in other types of cancer.

Funding from the National Cancer Institute supported this research.

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Contact: Darrell E. Ward
Ohio State University

New Study Focuses On Radiation-associated Cancer Risks

2007-04-15T22:39:00.001-07:00

Concerns about the risk of radiation-induced cancer are growing with the increasing number of cancer patients surviving long term. To address these concerns, Herman Suit and his colleagues Saveli Goldberg, Andrzej Niemeierko, Marek Ancukiewicz, Eric Hall, Michael Goitein, Winifed Wong and Harald Paganetti examined data on radiation-induced neoplastic transformation of mammalian cells in vitro and on the risk of an increase in cancer incidence after radiation exposure in mice, dogs, monkeys, the atomic bomb survivors, persons exposed occupationally, and patients treated with radiation.

The study appears in the January issue of the journal Radiation Research.

The authors found that there is great heterogeneity in the risk of radiation-associated cancer between species, strains of a species, and organs within a species. Currently, the heterogeneity between and within patient populations of virtually every parameter considered in risk estimation results in substantial uncertainty in quantification of a general risk factor.

One implication of their review is that reduced risks of secondary cancer should be achieved by any technique that achieves a dose reduction down to '0.1 Gy (i.e., the dose to tissues distant from the target). Based on their study, they conclude that the proportionate gain should be greatest for dose decrement to less than 2 Gy.

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Contact: Herman Suit
Radiation Research Society

Clear Guidelines On Oral Chemotherapy Needed

2007-04-15T22:34:00.001-07:00

Current practices around the use of oral chemotherapy in US cancer centres need to be improved, say doctors in a study on bmj.com.

Common malignancies can be treated with oral chemotherapy - a treatment which is increasingly used across the USA and internationally.

Researchers from Boston set out to analyse the guidelines and practices used by comprehensive cancer centres for the provision of oral chemotherapy. Forty-two centres took part in the study. Variations in practice emerged in the prescribing methods, consent requests and the coordination and monitoring of treatment. They found that few of the safeguards which are routinely used for infusion chemotherapy were adopted for oral chemotherapy treatment.

Most of the 42 organisations which took part in the study had no required elements for prescribing oral chemotherapy and few requested patients' written consent for off protocol prescribing. Only one in three organisations required a clinician to note the body surface area or calculation of dose on the prescription, and only one in four required the patients' diagnosis or protocol.

Nearly a quarter of the centres had no formal process for monitoring patients' adherence. In the past year respondents at 10 centres reported at least one serious adverse drug event related to oral chemotherapy and respondents at 13 centres reported a 'serious near miss'.

The authors conclude that 'prescribing, monitoring and coordination, pharmacy practices and education of patients for oral chemotherapy vary substantially. Despite clinicians' concerns about oral chemotherapies, there is no apparent consensus among oncology professionals about safe practices for these drugs. The oncology community must define safe medication practices appropriate for oral chemotherapy, develop practice guidelines and accelerate their adoption."

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Contact: Emma Dickinson
BMJ-British Medical Journal

Diabetes Drug Shows Promise For Preventing Brain Injury From Radiation Therapy

2007-04-15T21:37:00.001-07:00

Researchers at Wake Forest University School of Medicine are the first to report that in animal studies, a common diabetes drug prevents the memory and learning problems that cancer patients often experience after whole-brain radiation treatments.

"These findings offer the promise of improving the quality of life of these patients," said Mike Robbins, Ph.D., senior researcher. "The drug is already prescribed for diabetes and we know the doses that patients can safely take."

Whole-brain radiation is widely used to treat recurrent brain tumors as well as to prevent breast cancer, lung cancer and malignant melanoma from spreading to the brain. About 200,000 people receive the treatment annually, and beginning about a year later, up to one-half develop progressive cognitive impairments that can affect memory, language and abstract reasoning.

In the current issue of the International Journal of Radiation Oncology - Biology - Physics, Robbins and colleagues report that rats receiving the diabetes drug piolitazone (sold under the trade name Actos®) before, during and after radiation treatments did not experience cognitive impairment.

The scientists compared whether treatment with Actos for four weeks or for 54 weeks after radiation would be more effective, and found there was not a significant difference.

The study involved young adult rats that received either radiation treatment equal to levels received by humans or a "sham" treatment involving no radiation. Animals in both groups received either a normal diet or a diet containing the diabetes drug.

Cognitive function was assessed a year after the completion of radiation therapy using an object recognition test. Rats receiving radiation exhibited a significant decrease in cognitive function, unless they received the diabetes drug for either four or 54 weeks after radiation.

"This could be easily applied to patients," said Robbins, a professor of radiation biology. "We know the drugs don't promote tumor growth, and in some cases may inhibit it."

Currently, there are no known treatments to prevent cognitive impairments, and Robbins said the aging of the American population makes it imperative to solve the problem.

"Cancer is a disease of old age, so the number of people getting whole-brain radiation will increase," he said.

In essence, radiation causes the cognitive problems because it speeds up the brain's aging process. Recent research suggests that a cause may be chronic inflammation or oxidative stress. Oxidative stress occurs when cells cannot remove free radicals, or structurally unstable cells that can damage healthy cells.

The study by Robbins and colleagues was based on evidence that the diabetes drug pioglitazone prevents inflammation. The drug activates a specific type of peroxisome proliferator-activated receptors (PPARs) that control fat and glucose metabolism, and may be involved in inflammation.

Robbins said because the drug shows promise for preventing cognitive impairment, it may allow doctors to give higher doses of radiation. Currently, while higher doses of radiation have been associated with longer survival, dose is limited because of potential damage to surrounding healthy tissue.

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The research is supported by the National Cancer Institute. Co-researchers were Weiling Zhao, Ph.D., Valerie Payne, B.S., Ellen Tommasi, B.S., Debra Diz, Ph.D., and Fang-Chi Hsu, Ph.D., all with Wake Forest.

Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university's School of Medicine. U.S. News & World Report ranks Wake Forest University School of Medicine 18th in family medicine, 20th in geriatrics, 25th in primary care and 41st in research among the nation's medical schools. It ranks 35th in research funding by the National Institutes of Health. Almost 150 members of the medical school faculty are listed in Best Doctors in America.

Contact: Karen Richardson
Wake Forest University Baptist Medical Center

Tumor Cells Replace The Need For Growth Factors By Using Other Stimulators

2007-04-15T21:34:00.001-07:00

One feature of tumor cells that makes them cancerous is their ability to grow in the absence of the signals that normal cells require to grow. For example, breast cancer is often associated with the ability of the tumor cells to grow in the absence of a growth factor known as EGF. In many cases, the tumor cells become independent of EGF through genetic mutations that result in the receptor for EGF or its downstream signaling proteins becoming constantly activated. However, a study using a human breast cancer cell line, which appears online on January 11 in advance of publication in the February print issue of the Journal of Clinical Investigation, shows that increased amounts of another molecule that can activate the EGF receptor (TGF-alpha) can also cause the tumor cells to become independent of EGF.

Mina Bissell and Paraic Kenny from the University of California, Berkeley, showed that a human breast cancer cell line expressed high levels of TGF-alpha, which can bind and activate the EGF receptor. Expression of high levels of TGF-alpha required a protein known as TACE, which cleaves a precursor form of TGF-alpha to generate the active form of the protein, and inhibition of TACE impaired the tumorigenic potential of the breast cancer cell line. Importantly, high levels of expression of TGF-alpha and TACE were found to correlate with and be predictive of a poor outcome in patients with breast cancer. This study therefore identifies a new pathway by which tumor cells can become independent of EGF, and the authors suggest that targeting this pathway might provide a new approach to treating breast cancer and other cancers in which the tumor cells grow independently of EGF, such as colon cancer.

TITLE: Targeting TACE-dependent EGFR ligand shedding in breast cancer

AUTHOR CONTACT:

Mina J. Bissell
University of California, Berkeley, California, USA.

Paraic A. Kenny
University of California, Berkeley, California, USA.

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JCI table of contents -- January 11, 2006

Contact: Karen Honey
Journal of Clinical Investigation

Survey Reveals Need For Standardized Oral Chemotherapy Prescribing Practices, Safeguards

2007-04-15T20:37:00.001-07:00

Despite the widespread use of prescribing safeguards for infusion chemotherapy, few of those measures have been implemented with oral chemotherapy, according to a study led by researchers at Dana-Farber Cancer Institute.

In the Jan. 13 issue of the British Medical Journal, Saul N. Weingart, MD, PhD, vice president for patient safety at Dana-Farber, and his colleagues report that a survey of National Cancer Institute-designated comprehensive cancer centers found few organizations with standardized prescribing practices for oral chemotherapy.

"Given how quickly oral chemotherapies have become standard care for a growing number of cancers, we were not surprised to find variations in how organizations prescribe and monitor the use of these agents," said Weingart. "It was surprising, however, that few of the safeguards used with infusion chemotherapy have been adopted for oral chemotherapy."

The researchers sent a survey on the current practices for prescribing, coordinating and monitoring, dispensing, and educating patients about oral chemotherapy to 54 NCI-designated comprehensive cancer centers, of which 42 centers responded.

Weingart said the survey revealed significant variations in the manner prescriptions were generated at most centers and in the amount of information required to complete them.

Nearly 70 percent of the centers (29) used handwritten orders for the majority of oral chemotherapy prescriptions, five percent (2) used pre-printed paper prescriptions, and 14 percent (6) used computed-based prescription order entry systems.

An analysis of the information required to order prescriptions for six oral chemotherapies found that few centers mandated the inclusion of the patient's diagnosis (26 percent), the treatment's schedule and duration (9 percent), or the patient's body surface area (BSA) calculation, which is used to determine appropriate and safe drug dosage level, and only 21 percent of the centers required a second physician to review and approve the chemotherapy order. More than half of the centers had no required elements for oral chemotherapy prescriptions, noted Weingart, who is an associate professor of medicine at Harvard Medical School.

The respondents also reported that between 2004 and 2005 at least one serious adverse drug event related to oral chemotherapy occurred at 10 centers, and 13 centers experienced a 'serious near miss.'

"The growing availability of effective oral chemotherapy, especially the new class of 'targeted biologic therapies,' is one of the wonderful recent advances in cancer care, as it has given cancer patients unprecedented convenience compared to intravenous infusion therapy," said paper co-author Lawrence Shulman, MD, chief medical officer at Dana-Farber and an associate professor of medicine at Harvard Medical School. "However, these findings underline the importance of forging a consensus in the oncology field on standardized safeguards and practices for prescribing and monitoring the use of these drugs."

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The paper's other authors are Daniela Brouillard, Laurinda Morway, EdM, Ann Partridge, MD, MPH, Sylvia Bartel, RPh, MHP, and Maureen Connor, RN, of Dana-Farber; and Jonathan Flug, Tufts University School of Medicine, Boston.

The research was supported by the Center for Patient Safety at Dana-Farber and the Agency for Healthcare Research and Quality

Dana-Farber Cancer Institute (http://www.dana-farber.org/) is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), designated a comprehensive cancer center by the National Cancer Institute.

Contact: Bill Schaller
Dana-Farber Cancer Institute

Advanced Kidney Cancer - Median Progression-free Survival Doubled For Patients Treated With Nexavar (sorafenib), Phase III Data

2007-04-15T20:34:00.001-07:00

Bayer HealthCare today announced the publication of encouraging Phase III data on sorafenib tablets - a treatment for patients with advanced renal cell carcinoma (RCC/kidney cancer), in the New England Journal of Medicine (NEJM).

Sorafenib is the first, multi-kinase inhibitor indicated for the treatment of patients with advanced RCC who have failed prior interferon-alpha or interleukin-2 based therapy and also 1st line when patients are considered unsuitable for such therapy.

Patients treated with sorafenib demonstrated a doubling of median progression-free survival (PFS) (5.5 months vs. 2.8 months) compared to patients receiving placebo (p-value< 0.001)1. The data, as assessed by independent radiologic review, are taken from the largest randomised controlled trial ever conducted in advanced RCC known as 'Treatment Approaches in Renal Cancer Global Evaluation Trial' TARGET - study.

"Sorafenib and agents like it are exciting new treatments for patients with advanced kidney cancer who have no good standard options in this country at present," said study investigator Tim Eisen, Professor of Medical Oncology, Cambridge. He added: "The vast majority of patients can tolerate treatment easily. The main job for us now is to secure these drugs for the NHS."

TARGET - a multi-national, randomised, placebo-controlled Phase III study of sorafenib administered as a single agent was initiated in 2003.В More than 900 patients with advanced RCC, who had previously failed one prior systemic therapy, were enrolled in 117 sites worldwide and randomised into two treatment arms of equal numbers to receive either 400 mg sorafenib or placebo twice a day. 1

PFS measures the time that a patient lives without evident tumour growth. In a planned sub-group analysis the benefit in PFS was seen in all subgroups studied, including patients who had not received conventional treatment, such as interleukin-2 or interferon-alpha. After the PFS endpoint was met in April 2005, Bayer discussed the clinical and statistical significance of this analysis with the principal investigators, the independent data monitoring committee and with regulatory authorities and agreed that it would not be ethical to continue the study with a placebo-control arm. The study was subsequently modified and all patients in the trial were offered access to sorafenib.

A further interim analysis of overall survival (OS) В based on 367 deaths and after 48% of the placebo patients (216 patients) had crossed over to sorafenib showed that median overall survival was 19.3 months for patients in the sorafenib group and 15.9 months for those in the placebo group (p=0.02). This analysis did not reach pre-specified O'Brien-Fleming boundaries for statistical significance.1

In the phase III study, sorafenib was generally well tolerated. The most common reported treatment-emergent adverse events of any severity were diarrhoea, rash, fatigue, hand-foot skin reaction, alopecia, nausea, pruritus, hypertension, vomiting, erythema and dry skin.2

About Sorafenib:

When launched in July 2006, sorafenib was the first new kidney cancer treatment in Europe for over 10 years.

Mechanism of Action:

Sorafenib is an oral multi-kinase inhibitor that targets both the tumour cell and tumour vasculature. In preclinical models, sorafenib targeted members of two classes of kinases (tyrosine kinases and serine/threonine kinases) known to be involved in both tumour cell proliferation (tumour growth) and tumour angiogenesis (tumour blood supply) - two important cancer growth activities. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-ОІ, c-KIT and FLT-3.2

Indication:

Sorafenib, (200 mg film-coated tablets) is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy and also 1st line when patients are considered unsuitable for such therapy.2

Sorafenib is being evaluated as a single agent in a Phase III clinical trial for the treatment of advanced hepatocellular carcinoma (HCC), or liver cancer, a study that has completed enrolment. A Phase III clinical trial of Nexavar combined with carboplatin and paclitaxel in non-small cell lung cancer (NSCLC) for treatment-naive patients was initiated in the first half of 2006. In addition to company-sponsored trials, there are a number of sorafenib studies being sponsored by government agencies, cooperative groups, and individual investigators.

About Kidney Cancer:

The Disease:

More than 6,600 people are diagnosed with kidney cancer each year in the UK. Kidney cancer causes around 3,600 deaths each year in the UK.3 In adults in England and Wales almost 90% of malignant kidney tumours arise in the renal parenchyma and the renal pelvis.3 Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, causing up to 85 percent of all kidney cancers.4

Key Statistics:

Kidney cancer affects both men and women with a ratio of 5 new diagnoses in men for every 3 in women3 Between 1975 and 2002, the incidence of kidney cancer in the UK has almost doubled for both men and women aged over 65 years.3

In men incidence rates increased by 79% between 1975 and 2002 (from 7.1 in 100,000 in 1975 to 12.7 per 100,000 in 2002), and by 90% in women (from 3.2 to 6.1 per 100, 000) over the same time period, mainly affecting men over 65 and women over 55 years.3

Risk Factors:

The major risk factors for kidney cancer include age and sex, obesity, smoking, and several genetic and medical conditions. Other factors such as phenacetin use and occupation also increase risk but these exposures are not widespread and most likely account for a small number of cases.5

Symptoms:

In the early stages kidney cancer does not generally cause any symptoms.3

Late symptoms include6: blood in the urine - haematuria; low back pain unrelated to injury; a lump in the abdomen in the region of the kidneys; fatigue; weight loss; recurrent fevers not associated with colds or flu; high blood pressure; swelling of the ankles and legs.

Treatment:

The treatment of kidney cancer depends on the severity of the cancer and the patient's overall health. The main treatment for kidney cancer is surgery4, which is effective when all of the cancer is removed.

For further information please visit: http://info.cancerresearchuk.org

Nexavar(R) is a registered trademark of Bayer Pharmaceuticals Corporation.

About Bayer HealthCare:

Bayer HealthCare AG, with sales of approximately 9.4 billion Euros in 2005, is one of the world's leading, innovative companies in the healthcare and medical products industry. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. Bayer Pharmaceuticals Corporation is part of the new Global Pharmaceutical Division, established January 1, 2006, which consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Haematology/Cardiology; Oncology and Primary Care.В Bayer HealthCare AG employed 33,800 people worldwide in 2005.

Bayer HealthCare AG's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.

http://www.bayerhealthcare.com

References:

1. Escudier B et al, New Engl J Med 2007 356 (2): 11-20
2. В Nexavar Summary of Product Characteristics
3. Cancer Research UK, Cancer Statistics by Type, kidney cancer
4. Cohen N. N Engl J Med, 2005; 353:В 2477-2490
5. Quin, M., et al. Cancer Trends in England and Wales 1950-1999. ed., Vol. SMPS No. 66. 2001: TSO
6. American Cancer Society, Detailed Guide: Kidney Cancer - Surgery

Top Cancer Meeting Breaks Attendance Record For 2006

2007-04-15T19:37:00.001-07:00

The American Society for Therapeutic Radiology and Oncology broke an all-time attendance record for its 48th Annual Scientific Meeting, held November 5-9, 2006, at the Pennsylvania Convention Center in Philadelphia. ASTRO recorded more than 11,800 attendees at the 2006 Annual Meeting, compared to more than 10,300 attendees in 2005.

2006 was a successful year for ASTRO's Annual Meeting. The Annual Meeting brought an estimated $34 million in revenue to Philadelphia and was the largest convention to visit the city in 2006 according to the Philadelphia Convention and Visitors Bureau. Also last year, ASTRO's Annual Meeting was selected by Tradeshow Week, a respected weekly industry magazine, as one of the 50 fastest growing tradeshows in the United States and Canada. This was the third time in four years ASTRO received this honor.

"ASTRO's Annual Meeting is an opportunity for my colleagues in the cancer community to come together to learn the latest in cancer research while previewing new technology, all with the goal of better helping our patients beat cancer," said K. Kian Ang, M.D., Ph.D., ASTRO's Chair. "Our meeting in Philadelphia was exemplary in showcasing the best of what's to come in our field. I'm particularly grateful to my colleagues Steve Hahn and Peter Mauch for their hard work putting together such commendable scientific program and educational sessions."

"Our Annual Meeting is the premier scientific meeting in the field of radiation oncology," said Laura I. Thevenot, ASTRO's Chief Executive Officer. "I am so proud of Michele Cordie in Meetings, Kathy Thomas in Education and the rest of the ASTRO staff for their Herculean efforts to manage the complicated logistics of the meeting while putting together a top-notch scientific program. This meeting was our largest and we look forward to another great meeting in Los Angeles."

ASTRO's 49th Annual Meeting will be held October 28 through November 1, 2007, at the Los Angeles Convention Center in Los Angeles.

В ASTRO is the largest radiation oncology society in the world, with more than 8,500 members who specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, biology and physics, the Society is dedicated to the advancement of the practice of radiation oncology by promoting excellence in patient care, providing opportunities for educational and professional development, promoting research and disseminating research results and representing radiation oncology in a rapidly evolving socioeconomic healthcare environment.

The American Society for Therapeutic Radiology and Oncology (ASTRO)
8280 Willow Oaks Corporate Drive, Suite 500
Fairfax, VAВ 22031
http://www.astro.org
http://www.rtanswers.org

NeoRecormon Gains European Approval For Convenient Once Weekly Treatment Of Anaemia In Patients With Solid Cancers

2007-04-15T19:34:00.001-07:00

Roche announced today that it has received European marketing approval for a simple and convenient once weekly subcutaneous injection of NeoRecormon (epoetin beta) 30,000 IU for the treatment of anaemia in patients with solid cancers receiving chemotherapy. This expansion of the product label means that patients will no longer have the burden of three injections per week and their anaemia can be managed in a more convenient way.

Anaemia affects up to 95% of cancer patients receiving chemotherapy.1 It can develop as a result of the cancer itself or as a consequence of its treatment. For most patients anaemia manifests itself as an extreme and overwhelming fatigue that makes the impact of cancer even more devastating.

NeoRecormon 30,000 IU once weekly is proven to effectively2 and rapidly3,4 correct anaemia irrespective of the type of chemotherapy patients receive. It also reduces the need for blood transfusions by at least 50% compared to standard care5,6 and has been shown to significantly increase the time until patients need a first transfusion.7 Patients treated with NeoRecormon often experience an improvement in their quality of life8 and an increase in their daily energy levels.6,9

Key supportive data for the new label came from the BRAVE (BReast cancer - Anaemia and the Value of Erythropoietin) study, which was conducted in women with metastatic breast cancer receiving chemotherapy5,7,10 and the NAUTICA study conducted in patients with a wide range of cancer types also receiving chemotherapy.3

About NeoRecormon

NeoRecormon is prescribed for the treatment of symptomatic anaemia in patients with cancer. Treating anaemia increases red blood cell (haemoglobin) numbers and oxygen levels allowing the body to function effectively, which improves patients' quality of life and reduces morbidity.

NeoRecormon is one of Roche's leading biotechnology achievements and market leader in the countries in which it is sold.

With the label expansion announced today NeoRecormon 30,000 IU once weekly is now indicated for the treatment of symptomatic anaemia in adult patients with solid and lymphoid cancers receiving any form of chemotherapy. Treatment with NeoRecormon is initiated when patients' haemoglobin level is 11 g/dl or below and given to maintain a haemoglobin level of up to 13g/dl.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (http://www.roche.com).

All trademarks used or mentioned in this release are protected by law.

References

1. Groopman & Itri. Natl Cancer Inst 1999;91:1616 34.

2. Leonard et al. Ann Oncol 2004; 15 (Suppl 3):iii 50 Abstract 188P.

3. SpaГ«th et al 2006; 17 (Suppl 9): ix294 Abstract 1020P.

4. Boogaerts et al. Anticancer Res. 2006; 26:479-484.

5. Marangolo et al. Eur J Cancer Suppl 2005; 3: 388 Abstract 1347.

6. OrdГіnez et al. Lung Cancer 2005; 49(Suppl 2): S339 Abstract P-836.

7. Aapro et al. 29th Annual San Antonio Breast Cancer Symposium 2006; Poster 6095.

8. Boogaerts et al. Br J Cancer 2003; 88: 988-995.

9. de Castro et al. Cancer Chemother Pharmacol 2006; Jul 28 (Epub ahead of print).

10. Marangolo et al. Journal of Clinical Oncology 2005;23: 16S, Part I of II: 8141.

Roche
http://www.roche.com

ERBITUX® Phase III Study Meets Primary Endpoint In First-Line Treatment Of Metastatic Colorectal Cancer

2007-04-15T18:37:00.001-07:00

ImClone Systems Incorporated (NASDAQ: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that a Phase III study of ERBITUX® (cetuximab) plus FOLFIRI (an irinotecan- based chemotherapy) met the primary endpoint of increasing median duration of progression-free survival over FOLFIRI alone in patients with previously untreated metastatic colorectal cancer (mCRC). More than 1,000 patients were recruited from around the world to participate in the study, known as the CRYSTAL1 study.

"Despite advancements, metastatic disease remains difficult to treat. This study demonstrates the potential benefit of adding ERBITUX to first-line treatment of metastatic colorectal cancer," said Eric Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems.

"These results provide important new information for patients with metastatic colorectal cancer, and are part of a comprehensive clinical development program designed to fully understand the potential uses of ERBITUX for cancer patients," said Martin Birkhofer, M.D., Vice President, Oncology Global Medical Affairs, Bristol-Myers Squibb.

The study was conducted by Merck KGaA, Darmstadt, Germany, ImClone Systems' ERBITUX partner outside of North America. Results have been submitted for presentation at the 2007 American Society of Clinical Oncology Annual Meeting in Chicago in June.

About ERBITUX® (Cetuximab)

ERBITUX is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumor cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1). In vitro assays and in vivo animal studies have shown that binding of ERBITUX to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production. In vitro, ERBITUX can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types. While the mechanism of ERBITUX' anti-tumor effect(s) in vivo is unknown, all of these processes may contribute to the overall therapeutic effect of ERBITUX. EGFR is part of a signaling pathway that is linked to the growth and development of many human cancers, including those of the head and neck, colon and rectum.

ERBITUX (Cetuximab), in combination with radiation therapy, is indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. ERBITUX as a single agent is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.

ERBITUX is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma (mCRC) in combination with irinotecan for patients who are refractory to irinotecan-based chemotherapy, and as a single agent for patients who are intolerant to irinotecan-based therapy. The effectiveness of ERBITUX for the treatment of EGFR-expressing mCRC cancer is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX for the treatment of EGFR-expressing mCRC.

For full prescribing information, including boxed WARNINGS regarding infusion reactions and cardiopulmonary arrest, visit http://www.erbitux.com/.

Important Safety Information

Grade 3/4 infusion reactions, rarely with fatal outcome (<1 in 1000), occurred in approximately 3% (46/1485) of patients receiving ERBITUX (Cetuximab) therapy. These reactions are characterized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), urticaria, hypotension, and/or cardiac arrest. Severe infusion reactions require immediate and permanent discontinuation of ERBITUX therapy.

Most reactions (90%) were associated with the first infusion of ERBITUX despite the use of prophylactic antihistamines. Caution must be exercised with every ERBITUX infusion as there were patients who experienced their first severe infusion reaction during later infusions. A 1-hour observation period is recommended following the ERBITUX infusion. Longer observation periods may be required in patients who experience infusion reactions.

Cardiopulmonary arrest and/or sudden death occurred in 2% (4/208) of patients with squamous cell carcinoma of the head and neck treated with radiation therapy and ERBITUX as compared to none of 212 patients treated with radiation therapy alone. Fatal events occurred within 1 to 43 days after the last ERBITUX treatment. ERBITUX in combination with radiation therapy should be used with caution in patients with known coronary artery disease, congestive heart failure and arrhythmias. Close monitoring of serum electrolytes, including serum magnesium, potassium, and calcium during and after ERBITUX therapy is recommended.

Severe cases of interstitial lung disease (ILD), which was fatal in one case, occurred in less than 0.5% of 774 patients with advanced colorectal cancer (mCRC) receiving ERBITUX. There was one case of ILD reported in 796 patients with head and neck cancer receiving ERBITUX in clinical studies.

In clinical studies of ERBITUX, dermatologic toxicities, including acneform rash, skin drying and fissuring, and inflammatory and infectious sequelae (eg, blepharitis, cheilitis, cellulitis, cyst) were reported. In 208 patients receiving ERBITUX + RT, acneform rash was reported in 87% (17% severe) as compared to 10% in 212 patients treated with radiation therapy alone (1% severe). In patients receiving ERBITUX alone, 76% (N=103) experienced acneform rash (1% severe). In patients with mCRC, acneform rash was reported in 89% (686/774) of all treated patients, and was severe in 11% (84/774). Subsequent to the development of severe dermatologic toxicities, complications including S. aureus sepsis and abscesses requiring incision and drainage were reported. Sun exposure may exacerbate these effects. A related nail disorder, occurring in 12% (0.4% Grade 3) of patients, was characterized as a paronychial inflammation.

The safety of ERBITUX in combination with radiation therapy and cisplatin has not been established. Death and serious cardiotoxicity were observed in a single-am trial with ERBITUX, delayed, accelerated (concomitant boost) fractionation radiation therapy, and cisplatin (100 mg/m2) conducted in patients with locally advanced squamous cell carcinoma of the head and neck. Two of 21 patients died, one as a result of pneumonia and one of an unknown cause. Four patients discontinued treatment due to adverse events. Two of these discontinuations were due to cardiac events (myocardial infarction in one patient and arrhythmia, diminished cardiac output, and hypotension in the other patient).

The incidence of hypomagnesemia (both overall and severe [NCI CTC Grades 3 & 4]) was increased in patients receiving ERBITUX alone or in combination with chemotherapy as compared to those receiving best supportive care or chemotherapy alone based on ongoing, controlled clinical trials in 244 patients. Approximately one-half of these patients receiving ERBITUX experienced hypomagnesemia and 10-15% experienced severe hypomagnesemia. Electrolyte repletion was necessary in some patients and in severe cases, intravenous replacement was required. Patients receiving ERBITUX therapy should be periodically monitored for hypomagnesemia, and accompanying hypocalcemia and hypokalemia during, and up to 8 weeks following the completion of, ERBITUX therapy.

The most serious adverse reactions associated with ERBITUX in combination with radiation therapy in 208 patients with head and neck cancer were infusion reaction (3%), cardiopulmonary arrest (2%), dermatologic toxicity (2.5%), mucositis (6%), radiation dermatitis (3%), confusion (2%), and diarrhea (2%). The most serious adverse reactions associated with ERBITUX in mCRC clinical trials (N=774) were infusion reaction (3%), dermatologic toxicity (1%), interstitial lung disease (0.4%), fever (5%), sepsis (3%), kidney failure (2%), pulmonary embolus (1%), dehydration (5% in patients receiving ERBITUX with irinotecan, 2% in patients receiving ERBITUX as a single agent) and diarrhea (6% in patients receiving ERBITUX with irinotecan, 0.2% in patients receiving ERBITUX as a single agent).

The overall incidence of late radiation toxicities (any grade) was higher with ERBITUX in combination with radiation therapy compared with radiation therapy alone. The following sites were affected: salivary glands (65%/56%), larynx (52%/36%), subcutaneous tissue (49%/45%), mucous membranes (48%/39%), esophagus (44%/35%), skin (42%/33%), brain (11%/9%), lung (11%/8%), spinal cord (4%/3%), and bone (4%/5%) in the ERBITUX and radiation versus radiation alone arms, respectively.

The incidence of Grade 3 or 4 late radiation toxicities were generally similar between the radiation therapy alone and the ERBITUX plus radiation therapy arms.

The most common adverse events seen in patients with carcinomas of the head and neck receiving ERBITUX in combination with radiation therapy (n=208) versus radiation alone (n=212) were mucositis-stomatitis (93%/94%), acneform rash (87%/10%), radiation dermatitis (86%/90%), weight loss (84%/72%), xerostomia (72%/71%), dysphagia (65%/63%), asthenia (56%/49%), nausea (49%/37%), constipation (35%/30%) and vomiting (29%/23%). The most common adverse events seen in patients with carcinomas of the head and neck receiving ERBITUX as a single agent (N=103) were acneform rash (76%), asthenia (45%), pain (28%), fever (27%) and weight loss (27%).

The most common adverse events seen in patients with mCRC receiving ERBITUX with irinotecan (n=354) or ERBITUX as a single agent (n=420) were acneform rash (88%/90%), asthenia/malaise (73%/48%), diarrhea (72%/25%), nausea (55%/29%), abdominal pain (45%/26%), vomiting (41%/25%), fever (34%/27%), constipation (30%/26%), and headache (14%/26%).

About Colorectal Cancer

In the U.S., approximately 149,000 people will be diagnosed with cancer of the colon or rectum this year. Half of these patients have metastatic disease, or cancer that has spread to other organs, at the time of diagnosis. EGFR is expressed in up to 77.7% of colorectal cancer tumors. Colorectal cancer is the third most common cancer in both men and women.2

About ImClone Systems

ImClone Systems Incorporated is committed to advancing oncology care by developing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers. The Company's research and development programs include growth factor blockers and angiogenesis inhibitors. ImClone Systems' strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market. ImClone Systems' headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey.

Certain matters discussed in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions it can give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the company's ability to control or predict. Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this news release can be found in the company's filings with the Securities and Exchange Commission, including quarterly reports on Form 10-Q, current reports on Form 8-K and annual reports on Form 10-K. For forward-looking statements in this news release, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.

About Bristol-Myers Squibb

Bristol-Myers Squibb is dedicated to the discovery, development and exhaustive exploration of innovative cancer fighting therapies designed to extend and enhance the lives of patients living with cancer. More than 40 years ago, Bristol-Myers Squibb built a unified vision for the future of cancer treatment. With expertise, dedication and resolve, that vision led to the development of a diverse global portfolio of anti-cancer therapies that are an important cornerstone of care today. Hundreds of scientists at Bristol- Myers Squibb's Pharmaceutical Research Institute are studying ways to improve current cancer treatments and identify better, more effective medicines for the future.

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2005 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

1 Cetuximab combined with iRinotecan in first line therapY for metaSTatic colorectAL cancer

2 American Cancer Society: Cancer Facts and Figures 2006. http://www.cancer.org/downloads/STT/CAFF2006PWSecured.pdf. Accessed 5/16/06.

ERBITUX®
http://www.erbitux.com/

Brain Stem Cells Against Cancer?

2007-04-15T18:34:00.001-07:00

Leptin A Potential Link To Colon Cancer

2007-04-15T17:37:00.001-07:00

Tests on three human colon cancer cell lines showed that the fat-hormone 'leptin' may enhance the growth of colonic cancers. This finding could show why obese people are at increased risk of colon cancer. It could also point to new modes of treating this type of cancer, finds research from the University of California, San Diego School of Medicine, published today in BJS.

Leptin is a hormone that is released from fat cells (adipocytes) the more fat you have, the more leptin will be in your blood stream. This hormone plays an important role in regulating bodyweight and energy expenditure.

People who are obese have a two to three fold increased risk of developing colon cancer compared to similar normal-weight individuals. Research has also revealed that some colon cancer cells carry receptors for leptin.

The question is whether there is any evidence that these receptors could respond to increased levels of leptin that are caused by the obesity, and trigger the colon cancer cells to start dividing and growing. Now research shows that this may well be the case.

"These results may explain why obesity increases a person's risk of colonic cancer, and the fact that we have shown how leptin stimulates these cells means that drug companies may be in a better position to develop new treatments against the disease," says research co-author Dr Kim Barrett.

By culturing cancer cells in a laboratory, they found that leptin could stimulate growth. In two out of three cell lines, leptin also prevented the sort of programmed cell death (apoptosis) that allows for the orderly death of normal cells, but when reduced, can contribute to cancer.

The researchers then went on to reveal many of the signaling pathways that leptin affected in the cell. This showed that leptin does indeed interfere with many known intra-cellular systems that influence cancer cells.

About the JOHN WILEY & SONS

Wiley is a leading publisher for the scientific, technical, and medical (STM) communities worldwide. Our STM programs encompass journals, encyclopedias, and electronic products in subjects such as the life and medical sciences, chemistry, statistics and mathematics, electrical and electronics engineering, and select medical areas with an emphasis on cancer medicine. Through Wiley InterScience, we provide academic and corporate customers with online access to a broad range of STM content through licensing agreements.

JOHN WILEY & SONS
The Atrium
Southern Gate
Chichester
PO 19 8SQ
http://www.wiley.com

Researchers Urge Monitoring Of Bone Health During Chemotherapy

2007-04-15T17:34:00.001-07:00

In laboratory tests on mice, researchers found that a medication often used to reduce toxic side effects of chemotherapy induced bone loss and helped tumors grow in bone. So the researchers at Washington University School of Medicine in St. Louis are recommending increased awareness of bone health during cancer treatments.

The medication studied is a growth factor commonly used to help cancer patients recover healthy blood counts after chemotherapy, which can destroy white blood cells. Low levels of white blood cells leave patients susceptible to infection.

"This growth factor encourages bone breakdown, and any therapy that decreases bone density could potentially enhance tumor growth in bone," says senior author Katherine Weilbaecher, M.D., assistant professor of medicine and of cell biology and physiology. "But there are things that can be done to counteract this. Physicians should carefully monitor their cancer patient's bone health with regular bone density scans (DEXA) and prescribe medications to prevent bone loss when needed. And patients should consume enough calcium and vitamin D and get sufficient exercise to maintain strong bones."

Weilbaecher and her colleagues found that when they gave mice an eight-day course of the growth factor, called granulocyte colony-stimulating factor (G-CSF), the mice lost bone mass and experienced increased bone tumor growth when injected with cancer cells. Their study will appear in an upcoming issue of the journal Blood and is now available online.

G-CSF is known by the trade names Neupogen, Neulasta and Granocyte. Clinical use of G-CSF has recently increased because by speeding blood cell regrowth it allows patients to undergo more intensive chemotherapy regimens in which anticancer agents are given at more frequent intervals. Studies have suggested these dose-dense therapies could prolong survival in women with breast cancer.

"We are not at all advocating ending G-CSF use," says Weilbaecher, an oncologist with the Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital. "G-CSF seems to have significant benefits for some cancer patients."

Although G-CSF had a strong effect on bone metastasis in the experimental mice, early clinical trials in humans using G-CSF with chemotherapy have so far shown no adverse effects on survival and no increase in bone metastasis. In fact, breast-cancer patients undergoing dose-dense chemotherapy with G-CSF support tend to have a longer disease-free period than those getting standard dosing without G-CSF.

"It's possible that women on G-CSF-supported chemotherapy could do even better if we paid more attention to skeletal health," says lead author Angela Hirbe, an M.D./Ph.D. student in Weilbaecher's lab. "Strengthening the skeleton would not only help prevent osteoporosis and fractures but also might give patients a survival advantage."

In the laboratory mice studied, G-CSF increased the number and activity of bone cells called osteoclasts, which resorb bone material as part of the normal process of bone turnover. The resulting loss of bone density created a favorable environment for bone tumor growth.

When the researchers injected melanoma or breast cancer cells into mice, those getting G-CSF developed a two-fold increase in tumor burden, a measure of the size and severity of tumors, compared to those that did not receive G-CSF.

Interestingly, mice treated with a bisphosphonate, an anti-osteoporosis agent that inhibits osteoclasts, were resistant to the effects of G-CSF on bone tumor growth. Weilbaecher is currently investigating bisphosphonates as a means to prevent tumor metastasis to bone in breast cancer patients.

"We used G-CSF as a tool to understand the implications for tumor growth when osteoclast activity is revved up," Weilbaecher says. "But G-CSF isn't unique in its effect. For example, antihormone therapies used to treat breast and prostate cancer also can decrease bone mineral density. We would like to see clinical trials instigated to study the effects of such cancer therapies on bone health and tumor metastasis."

Hirbe AC, UluГ§kan -, Morgan EA, Eagleton MC, Prior JL, Piwnica-Worms D, Trinkaus K, Apicelli A, Weilbaecher K. Granulocyte colony-stimulating factor enhances bone tumor growth in mice in an osteoclast-dependent manner. Blood Dec 27, 2006 (advance online publication).

Funding from the National Cancer Institute supported this research.

Washington University School of Medicine's full-time and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children's hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked fourth in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children's hospitals, the School of Medicine is linked to BJC HealthCare. Siteman Cancer Center is the only NCI-designated Comprehensive Cancer Center within a 240-mile radius of St. Louis. Siteman Cancer Center is composed of the combined cancer research and treatment programs of Barnes-Jewish Hospital and Washington University School of Medicine.

Washington University in St. Louis
One Brookings Dr., Campus Box 1070
St. Louis, MO 63130
United States
http://www.wustl.edu/

High-Power MRI Helps Surgical Team Predict Outcomes In Unusual Tumor Cases

2007-04-15T16:37:00.001-07:00

Newly Released Prisoners At High Risk For Death

2007-04-15T16:34:00.001-07:00

15 Common Myths About Cervical Cancer

2007-04-15T15:37:00.001-07:00

About 9,700 women in the United States will be diagnosed with cervical cancer this year. It may seem like a small number, until you consider that another 1.2 million women will develop a pre-cancerous condition called dysplasia. And if left untreated, dysplasia will become cervical cancer.

"Because of Pap smears, a huge number of women are no longer dying of cervical cancer in this country, but this is a disease that can be almost entirely prevented," says Carolyn Johnston, M.D., clinical associate professor of obstetrics and gynecology at the University of Michigan Medical School and a gynecologic oncologist at the U-M Comprehensive Cancer Center.

In addition to early detection through screening, a new vaccine now available could help prevent cervical cancer. In honor of Cervical Cancer Awareness Month, which is January, U-M experts respond to common myths and misconceptions about this disease.

Myth 1: Cervical cancer cannot be prevented.

Truth: Infection with the human papillomavirus, or HPV, is an absolute requirement for cervical cancer to develop. This virus is transmitted sexually, but the majority of the most worrisome types of infection can be prevented with a newly available vaccine. Preventing HPV infection dramatically reduces a woman's risk of cervical cancer. In addition, cervical cancer usually develops slowly after persistent infection with HPV and will first appear as a precancerous condition called dysplasia. If detected at this stage, it can be effectively treated to prevent cervical cancer from developing. Screening with Pap smears and tests for HPV detect these pre-cancerous conditions so patients are treated early.

Behavioral issues can also influence cervical cancer. "A woman can reduce her risk of these problems by limiting the number of sexual partners over a lifetime, by not smoking cigarettes and by following accepted screening guidelines. Each of these behaviors relates to known risk factors for this disease," says Anthony Opipari, M.D., Ph.D., associate professor of obstetrics and gynecology at the U-M Medical School.

Myth 2: I'm too young to worry about cervical cancer.

Truth: The average age of cervical cancer patients is 48. While it's not common, women can be diagnosed in their 20s. HPV infection and the precancerous condition dysplasia are common in younger women.

Myth 3: I don't have intercourse, so I don't need the HPV vaccine.

Truth: HPV can be passed from one partner to another through intercourse, as well as orally and through touching. In 2006, the Food and Drug Administration a vaccine, Gardasil, to protect against four types of HPV, two of which are commonly linked to cervical cancer and two linked to genital warts. A CDC advisory committee recommended that Gardasil be given routinely to girls age 11-13. Until everyone is vaccinated, girls and women ages 13-26 are also candidates for the vaccine. Experts believe the vaccine should be given at a young age before a woman becomes sexually active.

Myth 4: I had the HPV vaccine, so I don't need to use condoms during sex.

Truth: The HPV vaccine will protect you from infection with four types of HPV but there are other strains of this virus and many other sexually transmitted diseases that it does not protect against. Continue using condoms to protect against STDs.

Myth 5: I don't need a Pap test.

Truth: A woman's first Pap test should be given when she turns 21 or three years after she begins having intercourse, whichever comes first. Recommendations differ for how often a woman should receive a Pap test. Ask your doctor how often you should be screened. Even if you have the HPV vaccine, you still need a regular Pap test. The vaccine targets four types of HPV but it will not protect against all the types of HPV that can cause cervical cancer, so it's still important to continue regular screenings.

Myth 6: I'm too old to need a Pap test any longer.

Truth: "We have seen an increase in cervical cancer and HIV in older populations," says Lauren Zoschnick, M.D., clinical assistant professor of obstetrics and gynecology at the U-M Medical School. "Women can have new sexual partners, which puts them at risk of cervical cancer and other STDs." Talk to your health care provider about the need to have Pap smears even if you have gone through menopause, have had a hysterectomy, or are over the age of 65.

Myth 7: My doctor gave me a pelvic exam, which is the same as a Pap test.

Truth: The Pap test collects cells from the cervix, which are sent to a lab to be evaluated. In a pelvic exam, your doctor physically examines the cervix and other parts of a woman's anatomy. Both are important to detect problems early.

Myth 8: My Pap test was abnormal, which means I must have cancer.

Truth: Not necessarily. You'll likely need follow-up tests, possibly a test for HPV, colposcopy or a biopsy to test for cancerous cells. An abnormal Pap test could indicate a precancerous condition that can be treated. Conversely, a negative Pap test does not always mean a woman is cancer-free. About 10 percent of all Pap tests return a false negative result, meaning the test did not identify a problem that is there. If you have problems such as bleeding or pain, seek further care even if your last Pap test was normal.

Myth 9: Cervical cancer has no symptoms.

Truth: Bleeding after intercourse, bleeding between menstrual periods or bleeding after menopause may indicate cervical cancer. Other symptoms include an abnormal discharge or pain in the pelvic region.

Myth 10: If I am diagnosed with cervical cancer, I am going to die.

Truth: Survival after cervical cancer caught in its earliest stage is 92 percent. The later it is diagnosed, the lower the chance of survival. Survival is lower in developing countries because of inadequate screening. Regular screening will help ensure cervical cancer is caught at an early, treatable stage.

Myth 11: After I finish treatment, I will live the rest of my life worried about cancer returning.

Truth: If cervical cancer is going to recur, it is most likely to happen in the first two years after treatment. Most patients are followed for five years, after which the risk of recurrence is extremely low.

Myth 12: I must have a hysterectomy to treat cervical cancer.

Truth: Early cervical cancer is typically treated with a hysterectomy, surgery that removes the cervix and uterus. But it's not the only option. Radiation and chemotherapy are used to treat more advanced disease and may also be options for women with early stage disease who cannot have surgery. Some women with early cervical cancer can also avoid hysterectomy with procedures such as a cone biopsy that removes only the cancerous tissue and a small margin of surrounding healthy tissue, or a procedure called radical trachelectomy, which removes the cervix but not the uterus.

Myth 13: I won't be able to conceive a child after cervical cancer treatment.

Truth: If you have a hysterectomy or radiation to treat cervical cancer, you will not be able to conceive. But newer surgical procedures help preserve a woman's fertility without compromising survival. A radical trachelectomy removes the cervix but not the uterus so that a woman can still conceive. For small, early cancers, a cone biopsy may be appropriate and will also preserve fertility.

Myth 14: A hysterectomy to treat cervical cancer will put me in menopause afterward.

Truth: Hysterectomy to treat cervical cancer does not remove the ovaries, which are what determines whether a person is menopausal. Cervical cancer very rarely spreads to the ovaries. Women who receive pelvic radiation to treat cervical cancer will likely experience menopause because the radiation will affect the ovaries.

Myth 15: Taking hormone replacement therapy will increase my risk of cervical cancer.

Truth: Cervical cancer does not respond to hormones like breast or ovarian cancers. Low doses of hormone replacement therapy can treat menopausal symptoms without increasing the risk of cervical cancer.

For more information about cervical cancer and the HPV vaccine, visit the following resources:

-- U-M Cancer Center: http://www.mcancer.org

-- U-M Cancer AnswerLine: 800-865-1125

-- Michigan Cancer Consortium: http://www.michigancancer.org/

-- National Cancer Institute: http://www.cancer.gov

-- HPV Questions and Answers: http://www.cdc.gov/std/hpv/STDFact-HPV-vaccine.htm

University of Michigan Health System
2901 Hubbard St., Ste. 2400
Ann Arbor, MI 48109-2435
United States
http://www.med.umich.edu/

Destructive Enzyme Shows A Benevolent Side

2007-04-15T15:34:00.001-07:00

New research shows that a recently discovered enzyme that destroys the messenger RNA (mRNA) for some proteins can also help to protect the mRNA during times of stress. The response might help cancer cells survive chemotherapy and radiation therapy.

The study examined a recently discovered enzyme called PMR1. That enzyme attaches to certain mRNA molecules and remains there like a hand grenade with its pin in place.

These mRNAs carry the information for making highly potent proteins, proteins that cells must stop making suddenly. When that 'stop' command arrives, the pin is pulled and the enzyme destroys the mRNA, quickly halting production of that protein.

This new study found, however, that under stress conditions, the same enzyme - while attached to the mRNA - helps form temporary shelters within the cell called stress granules. There, the mRNA can be protected so that production of the protein can quickly resume whenever the stress ends, perhaps insuring that the cell survives.

Stress granules are short-lived aggregates of mRNA and proteins, and they accumulate when cells are subjected to conditions such as starvation, low oxygen (which can occur within large tumors), chemotherapy or radiation therapy.

The study, led by researchers at Ohio State University's Comprehensive Cancer Center, is published in the December issue of the journal Molecular and Cellular Biology.

"The stress response protects cells from these conditions by sequestering mRNAs for those proteins not specifically involved in the stress response itself," says principal investigator Daniel R. Schoenberg, professor of molecular and cellular biochemistry and a researcher with Ohio State's Comprehensive Cancer Center.

"By understanding how PMR1 and similar enzymes are incorporated into stress granules and inactivated, we may be able to learn how to block this protective mechanism and make it harder for cancer cells to survive cancer therapies."

Schoenberg first discovered the PMR1 enzyme in 1995, and his lab has been actively studying it since that time.

For this study, Schoenberg and a group of colleagues wanted to learn if the enzyme also destroys its mRNA during periods of stress.

To answer the question, they used cultured cells to which they'd added active and mutant forms of the enzyme. They then stressed the cells using the chemical arsenite, a relative of arsenic.

The investigators found that during stress, the enzyme interacts directly with another protein called TIA-1, a key protein involved in assembling stress granules. This interaction draws the enzyme-mRNA complex into stress granules.

But the researchers were unable to detect any sign that the message was destroyed.

"The fact that we don't see an acceleration of mRNA decay suggests that something in the stress response protects these mRNAs from being degraded, even though the degrading enzyme PMR1 is there in the stress granules with its target mRNA."

Schoenberg and his colleagues will next study the other proteins within stress granules to try to learn how PMR1-mRNA complex is preserved.

Funding from the National Institute of General Medical Sciences supported this research.

Schoenberg collaborated on this study with Nancy Kedersha at Brigham and Women's Hospital and Harvard Medical School.

###

Contact: Darrell E. Ward
Ohio State University

Designer Hens Lay Anti-Cancer Eggs

2007-04-15T14:38:00.001-07:00

Scientists at Scotland's Roslin Institute that produced Dolly the Sheep have genetically modified "designer" hens to lay eggs containing proteins that can fight human forms of cancer and other diseases. It is thought this will make a range of existing drugs easier and cheaper to produce.

The hens are producing proteins that have the potential to treat arthritis, multiple sclerosis, and malignant melanoma, or skin cancer.

The results of this research are to be published in today's issue of the Proceedings of the National Academy of Sciences.

The Roslin team genetically engineered the hens by inserting the gene for the desired proteins into the ovalbumin gene, a protein in egg white. They chose two proteins: human interferon b-1a, which is used to treat a range of tumours and virus infections, and miR24, a monclonal antibody used in the treatment of skin cancer.

They started by using a virus to insert the protein DNA into the DNA of chick embryos. The chicks were hatched and the researchers found that the male ones had DNA in their semen. These were bred with normal hens and the female chicks that carried the new genes then went on to produce the eggs containing the desired proteins. Some 500 genetically modified, or "transgenic" hens have now been created in this way.

The news was welcomed by the UK's leading cancer charity, Cancer Research UK, at the weekend. Herbie Newell, director of translational research at the charity said that anything that speeds up the number of new treatments available and reduces their cost "must be welcomed".

Dr Helen Sang of the Roslin Institute and lead scientist on the project has been working on this for 15 years. It could still be another 15 years before drugs become available because of the long development cycle of such innovative treatments. First the patent trials have to be completed, that takes about 5 years, and then the drug development and approval takes another 10 years.

The idea is to produce the protein-based drugs in flocks of birds reared as "biofactories" much in the same way as chickens are for normal eggs. The proteins are quite straightforward to harvest from the egg-white.

Using genetically modified organisms to create drugs for treating humans is not new. Insulin for treating diabetes is produced in genetically modified bacteria. Other more complex proteins have been produced in the milk of sheep, goats, cows and rabbits. However this is the first time that birds have been used and the researchers think this method could lead to cheaper and faster drug production because of the shorter life cycle of hens and eggs.

This latest Roslin work forms part of the Avian Transgenic Project, which includes the biotechnology firms Viragen and Oxford BioMedica.

Proceedings of the National Academy of Sciences of the United States of America.

Use of biotechnology in pharmaceutical manufacturing (wikipedia)

Written by: Catharine Paddock
Writer: Medical News Today

Scripps Research Combination Therapy Obliterates New Vessel Growth In Tumors And Retinopathy

2007-04-15T14:34:00.001-07:00

The paper is being published online in the Proceedings of the National Academy of Sciences.

"While a number of new drugs that inhibit new blood vessel growth are now available in the clinics, no one so far has been cured with available anti-angiogenic agents," said Professor Martin Friedlander, a Scripps Research scientist and retina specialist at Scripps Clinic who led the study. "Our study shows that combining anti-angiogenic agents that target multiple angiogenic pathways can significantly increase the effectiveness of such a therapeutic approach. Such combination angiostatic therapy provides a whole new range of treatment options for patients with neovascular diseases, where complete inhibition of new blood vessel growth is the desired result."

While new blood vessel growth from preexisting capillaries ("angiogenesis") is fundamental to survival, the abnormal formation of new blood vessels ("neovascularization") contributes to the pathogenesis of tumor growth and metastasis as well as the vast majority of diseases that lead to catastrophic loss of vision. A number of angiostatic molecules have been used to impair blood vessel formation as clinical adjuncts to conventional radio- and chemotherapy. Others have proven to be modestly effective in treating neovascular eye diseases.

The new study combined the actions of three classes of angiostatic compounds, each targeting different angiogenic pathways, and showed striking results in the treatment of an animal model of glioblastoma, a highly malignant brain cancer, and ischemic retinopathy, excessive blood vessel growth in the eye that is a major cause of blindness worldwide.

"Our combination therapy reduced tumor mass and increased survival in the glioblastoma model," Friedlander said. "In models of neovascular eye diseases, the therapy resulted in complete inhibition of pathological neovascularization in more than 60 percent of the eyes; over 90 percent had greater than 75 percent inhibition of new vessel growth with no adverse affects on normal tissue vasculature. In contrast, individual therapies with comparable doses of individual drugs were minimally effective, if at all."

Importantly, Friedlander notes that the use of single therapies can result in the activation of alternative compensatory pro-angiogenic pathways designed to stimulate new vessel growth, while the combination approach significantly reduced such compensatory upregulation.

"The fact that multiple angiogenic pathways are activated in response to single therapies, but not to combination treatment, supports the hypothesis that compensatory mechanisms might prevent single angiostatics from inhibiting neovascularization," he said. "These results suggest that combination therapy prevents this natural compensation, enhancing the overall anti-angiogenesis effect."

In combination, the angiostatic therapies were effective at much lower concentrations than when used as individual monotherapies. Even when diluted up to 100-fold, the triple combination inhibited angiogenesis at levels comparable to optimal doses of any single therapy. A ten-fold dilution of the triple combination demonstrated extensive neovascular inhibition with complete inhibition observed in 44 percent of the treated retinas. At these same concentrations, the angiostatic activity of each monotherapy was negligible, indicating that combining multiple angiostatic drugs was synergistic rather than additive.

The effectiveness of combination therapies at relatively low doses may be a distinct advantage in therapy, the study noted. In the elderly or diabetic patients, high levels of circulating angiostatics could precipitate stroke or heart attack due to the fact that such patients make collateral blood vessels in hearts and brains that are starved for oxygen from vascular diseases such as arteriosclerosis, hypertension, and diabetes. For these and other patients, the use of lower doses of angiostatic therapies could minimize potential adverse side effects.

"The point of the study was to show proof-of-concept that targeting multiple angiogenic pathways will be more effective than inhibiting single ones due to potential compensatory upregulation," Friedlander said. "As more and more anti-angiogenic agents reach the market, there will be even more combinations to choose from. In our laboratory, we're now looking at new combinations of approved angiostatic drugs to see if we can achieve similar promising results that can have immediate translation into the clinic."

###

Other authors of the study, Combination Angiostatic Therapy Completely Inhibits Ocular and Tumor Angiogenesis, were Michael I. Dorrell, Edith Aguilar, Lea Scheppke, and Faith H. Barnett of The Scripps Research Institute. See: Proceedings of the National Academy of Sciences of the United States of America

The study was supported by the National Eye Institute, the Scripps Fonseca/Mericos Fund, the V. Kann Rasmussen and MacTel Foundations, and the Skaggs Scholars in Clinical Science.

About The Scripps Research Institute

The Scripps Research Institute is one of the world's largest independent, non-profit biomedical research organizations, at the forefront of basic biomedical science that seeks to comprehend the most fundamental processes of life. Scripps Research is internationally recognized for its discoveries in immunology, molecular and cellular biology, chemistry, neurosciences, autoimmune, cardiovascular, and infectious diseases, and synthetic vaccine development. Established in its current configuration in 1961, it employs approximately 3,000 scientists, postdoctoral fellows, scientific and other technicians, doctoral degree graduate students, and administrative and technical support personnel. Scripps Research is headquartered in La Jolla, California. It also includes Scripps Florida, whose researchers focus on basic biomedical science, drug discovery, and technology development. Currently operating from temporary facilities in Jupiter, Scripps Florida will move to its permanent campus in 2009.

Contact: Marisela Chevez
Scripps Research Institute

Poniard Pharmaceuticals And The Scripps Research Institute Broaden Research Collaboration

2007-04-15T13:38:00.001-07:00

The expanded collaboration will include the discovery of focal adhesion kinase (FAK) inhibitors to treat cancer and will be co-led by David Schlaepfer, Ph.D., associate professor in the Department of Immunology at The Scripps Research Institute in La Jolla, Calif., and Chris Liang, Ph.D., director of medicinal chemistry at Scripps Florida.

Poniard and Scripps' initial scientific collaboration represented the first major biotech collaboration for Scripps Florida, a division of The Scripps Research Institute in Palm Beach County. In addition to FAK inhibitors, the research initiative is focusing on discovering novel, small-molecule protein kinase inhibitors as therapeutic agents, including cancer treatments.

"We are pleased to have negotiated this broadened research collaboration with The Scripps Research Institute under the terms of our existing agreement, which enables us to access scientific expertise at both the Scripps La Jolla and Palm Beach County sites," said Jerry McMahon, Ph.D., chairman, president and CEO of Poniard. "Dr. Schlaepfer is an international expert in the study of FAK, and we believe that he will be an invaluable resource in our drug discovery efforts on this exciting and promising new cancer target."

Dr. Schlaepfer's research at Scripps focuses on molecular signaling that regulates cell motility and invasion. During cancer progression, tumor cells can acquire a highly motile and invasive phenotype. These properties directly promote tumor spread and metastasis. As FAK is commonly overexpressed in malignant human tumors, Dr. Schlaepfer is employing multiple strategies to inhibit FAK activity within tumor cells. He is the author of several papers on this topic, including those published in the Journal of Cell Biology, Cancer Research, Nature Cell Biology and Oncogene.

"FAK is associated with the invasion and metastasis of tumor cells and has recently been implicated in chemoresistance," added Dr. McMahon. "It is possible that inhibitors of FAK may enhance the activity of picoplatin in the treatment of solid tumors. We are looking forward to collaborating with Dr. Schlaepfer on this critical research."

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About The Scripps Research Institute

The Scripps Research Institute is one of the world's largest independent, non-profit biomedical research organizations, at the forefront of basic biomedical science that seeks to comprehend the most fundamental processes of life. Scripps Research is internationally recognized for its discoveries in immunology, molecular and cellular biology, chemistry, neurosciences, autoimmune, cardiovascular, and infectious diseases, and synthetic vaccine development. Established in its current configuration in 1961, it employs approximately 3,000 scientists, postdoctoral fellows, scientific and other technicians, doctoral degree graduate students, and administrative and technical support personnel. Scripps Research is headquartered in La Jolla, California. It also includes Scripps Florida, whose researchers focus on basic biomedical science, drug discovery, and technology development. Currently operating from temporary facilities in Jupiter, Scripps Florida will move to its permanent campus in 2009.

About Poniard Pharmaceuticals

Poniard Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the discovery, development and commercialization of innovative oncology products to impact the lives of people with cancer. Picoplatin, the Company's lead product candidate, is a new generation platinum therapy with an improved safety profile. An intravenous chemotherapeutic agent, it is designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors. Picoplatin is currently being studied in clinical trials for the treatment of small cell lung, colorectal and hormone-refractory prostate cancers. As part of the Company's strategic goal of building a diverse oncology pipeline, the Company is collaborating with The Scripps Research Institute on the discovery of novel, small-molecule, multi-targeted protein kinase inhibitors and focal adhesion kinase (FAK) inhibitors. For additional information please visit http://www.poniard.com/.

This release contains forward-looking statements, including statements regarding the Company's business model, drug development program and strategic collaborations and goals. The Company's actual results may differ materially from those indicated in these forward looking statements based on a number of factors, including anticipated operating losses, uncertainties associated with research, development, clinical trials, the results of later clinical testing and related regulatory approvals, future capital needs and uncertainty of additional financing, competition, uncertainties associated with intellectual property, dependence on third-party manufacturers, suppliers and collaborators, lack of sales and marketing experience, loss of key personnel, uncertainties associated with market acceptance, technology change and government regulation, general market conditions and the other risks and uncertainties described in the Company's current and periodic reports filed with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2005, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2006. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement to reflect new information, events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.

© 2007 Poniard Pharmaceuticals, Inc. All Rights Reserved.

Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.

For Further Information:

Poniard Pharmaceuticals

Julie Rathbun
Corporate Communications

Contact: Keith McKeown
Scripps Research Institute

Washington, D.C., Bill Requiring HPV Vaccine Would Save 'Thousands' Of Women's Lives, Editorial Says

2007-04-15T13:34:00.001-07:00

"Emotion and ignorance shouldn't thwart" a Washington, D.C., City Council bill that would require girls entering the sixth grade to receive Merck's human papillomavirus vaccine Gardasil and would "save the lives of thousands of women," a Washington Post editorial says (Washington Post, 1/11). Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. FDA in July 2006 approved the vaccine for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine. According to the legislation, sponsored by City Council Members Mary Cheh (D) and independent David Catania, female students would be required to show proof of vaccination before enrolling in the sixth grade in District of Columbia Public Schools, unless their parent or legal guardian chose to "opt out" of the requirement. The bill does not specify the circumstances under which girls would be allowed an exemption (Kaiser Daily Women's Health Policy Report, 1/10). According to the editorial, the bill gives parents the "right" to "have a say in the health management" of their children and "would mandate that parents get the data needed to make informed choices." Opposition to the measure because of "the misguided belief that the virus doesn't pose the same kind of threat to the public as other transmissible pathogens" or the belief that "receiving the vaccine will encourage promiscuity" do not "square with the fact[s]," the Post says. "If common sense wins out here, the [d]istrict will lead the nation in an important area of public health -- and will save some lives," the editorial concludes (Washington Post, 1/11).

Related Opinion Piece
If you have a daughter entering the sixth grade of a public school in the district next year, "your daughter is 11 and probably black, so the assumption" made by the bill is "she'll be having unprotected sex in no time -- but don't take offense," Washington Post columnist Courtland Milloy writes in an opinion piece. According to Milloy, Catania and Cheh, who he calls "two nice white people," proposed a program to vaccinate "girls under 13 in a predominantly black school system" against HPV. "After all, if the girls' parents can't protect them -- and, God knows, they can't protect themselves -- then somebody's got to do it." Milloy writes, "Forget about taking time to educate the public about HPV or exploring any adverse side effects of the vaccination. ... And please don't bring up that old paranoia about government agencies conducting medical experiments on black people. ... That practice was found to be unconstitutional -- eventually." He adds, "Let's just go right at these presumed-to-be promiscuous, 11-year-old black girls" (Milloy, Washington Post, 1/10).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Bayer And Onyx Announce Pivotal Nexavar Kidney Cancer Study Published In NEJM

2007-04-15T12:37:00.001-07:00

Bayer Pharmaceuticals Corporation (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) has announced that the New England Journal of Medicine has published their pivotal Phase III trial demonstrating that Nexavar® (sorafenib) tablets doubled median progression-free survival (PFS) in patients with advanced renal cell carcinoma (RCC), or kidney cancer. The data, as assessed by independent radiologic review, are from the Treatment Approaches in Renal Cancer Global Evaluation Trial (TARGET) - the largest randomized controlled trial ever conducted in advanced RCC.

"Historically, patients with kidney cancer have had limited treatment options and there has been a particularly critical need for new therapies to help patients with advanced disease," said co-principal investigator Ronald Bukowski, M.D., Director of the Experimental Therapeutics Program of The Cleveland Clinic Taussig Cancer Center in Cleveland, OH. "This landmark study demonstrated the efficacy, tolerability and clinical benefit of Nexavar, which has rapidly become a valuable weapon against this devastating disease."

Based on these data, Nexavar was granted U.S. Food and Drug Administration (FDA) approval for the treatment of patients with advanced RCC, or kidney cancer, on December 20, 2005. Since then, Nexavar has been approved in nearly 50 countries.

"Nexavar was the first new drug approved for patients with advanced kidney cancer in over a decade," said Bill Bro, President and Chief Executive Officer of the Kidney Cancer Association (KCA). "With the advent of targeted therapies such as Nexavar, there has been remarkable change - patients are experiencing improved outcomes without the toxic effects traditionally associated with chemotherapy."

Phase III Summary

More than 900 patients with advanced RCC were randomized one-to-one to receive either 400 mg Nexavar or placebo orally twice a day in this randomized, multi-national, placebo-controlled Phase III study. The endpoints of the study are overall survival (OS), PFS, overall response rate and safety. PFS measures the length of time that a patient lives without evident tumor growth or death.

PFS doubled to a median of 5.5 months in patients receiving Nexavar compared to 2.8 months for patients receiving placebo (p < 0.001). This represented a 56% reduction in the risk of progression (hazard ratio 0.44; 95% CI, 0.35 to 0.55) for patients on Nexavar versus placebo. All patient subgroups examined benefited regardless of performance status or risk group, including patients who had not received conventional treatment with biologics, such as interleukin-2 or interferon-alpha.

In May 2005, due to the clinical and statistical significance of the PFS data, the companies unblinded the trial and announced that patients who were receiving placebo were allowed to "cross over" to drug treatment. The first OS analysis conducted immediately before cross-over found a 39% improvement in OS for Nexavar patients (hazard ratio 0.72, p=0.018). A further OS analysis performed six months following cross over was based on 367 survival events (patient deaths) that had occurred by November 30, 2005. Results showed a continued trend toward improved survival, with a 23% reduction in the risk of death (19.3 months for Nexavar patients versus 15.9 months for placebo patients; hazard ratio 0.77, p=0.02), despite the fact that nearly half of placebo patients had "crossed over" to Nexavar. Patients continue to be followed and a final survival analysis will be available in the first half of 2007. The Phase III data published in NEJM have previously been communicated at international scientific congresses.

###

About Nexavar

Nexavar is an oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth. These kinases included RAF kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

Nexavar is currently approved in nearly 50 countries, including the United States and in the European Union, for the treatment of patients with advanced kidney cancer. In addition, Nexavar is being evaluated by the companies, international study groups, government agencies or individual investigators as a single agent or combination treatment in a wide range of cancers, including adjuvant RCC, advanced liver cancer, metastatic melanoma, non-small cell lung cancer and breast cancer.

About Kidney Cancer

Renal cell carcinoma is the most common form of kidney cancer. Nearly 208,000 people worldwide are diagnosed (about 37,000 Americans) with renal cell carcinoma each year and more than 102,000 of them die (about 12,000 Americans) from the disease annually. For more information on renal cell carcinoma, visit the Kidney Cancer Association (KCA) web site at: http://www.curekidneycancer.org/.

Important Safety Considerations for U.S. Patients Taking Nexavar

Based on the currently approved package insert for the treatment of patients with advanced kidney cancer, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common treatment-emergent adverse events with Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar vs. 28% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.

For U.S. Nexavar prescribing information, visit http://www.nexavar.com/.

About Onyx Pharmaceuticals, Inc.

Onyx Pharmaceuticals, Inc. is engaged in the development of novel cancer therapies that target the molecular basis of cancer. With its collaborators, the company is developing small molecule drugs, including Nexavar with Bayer Pharmaceuticals Corporation. For more information about Onyx's pipeline and activities, visit the company's web site at: http://www.onyx-pharm.com/.

About Bayer Pharmaceuticals Corporation

Bayer Pharmaceuticals Corporation (http://www.bayerpharma.com/) is part of the worldwide operations of Bayer HealthCare AG, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. Bayer HealthCare generated sales amounting to some 9.4 billion euros and employed 33,800 people worldwide in 2005.

The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. The new Pharmaceuticals division was established on January 1, 2006, and comprises the former Biological Products and Pharmaceutical divisions. Bayer HealthCare Pharmaceuticals now has three business units: Hematology/Cardiology, Oncology and Primary Care.

Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.

Forward Looking Statements

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including its Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

This news release also contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the timing, progress and results of the clinical development, regulatory processes, and commercialization efforts of Nexavar. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2005, filed with the Securities and Exchange Commission under the heading " Risk Factors" and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.

NEXAVAR® is a registered trademark of Bayer AG, Germany.

Mark Bennett
Bayer HealthCare

A New Target For The Treatment Of Breast Cancer:

2007-04-15T12:34:00.001-07:00

The active ingredient in a drug currently being tested to treat rheumatoid arthritis might also one day serve as an effective means of treating one of the deadliest forms of breast cancer. Researchers with the U.S. Department of Energy's Lawrence Berkeley National Laboratory (Berkeley Lab) have demonstrated that inhibiting the activity of the protease enzyme known as TACE can deprive tumor cells of a key factor needed for their proliferation. TACE is strongly present in a form of breast cancer which responds poorly to current therapies.

We have shown that inhibition of the TACE protease in breast cancer cells blocks the shedding of two critical growth factor proteins and results in an inhibition of a key signaling pathway that controls cell division," said Paraic Kenny, a post-doctoral cell biologist with the research group of Mina Bissell in Berkeley Lab's Life Sciences Division. "Based on analysis of cells grown in three-dimensional cultures, the inhibition of this protease results in the reversion of the malignant phenotype of these breast cancer cells and switches their behavior back to a phenotype very reminiscent of non-malignant breast epithelial cells."

Kenny is the co-author along with Bissell of a paper published in the Journal of Clinical Investigation entitled: Targeting TACE-Dependent EGFR-ligand Shedding in Breast Cancer. This paper presents the latest experimental results from an on-going investigation led by Bissell into the ecology of tumors.

It has long been Bissell's contention that "no tumor is an island." Tumor cells, she maintains, exist in the same microenvironment as healthy cells and must therefore appropriate normal physiological processes to facilitate their growth and spread. As she and her colleagues have repeatedly demonstrated, this idea can open up potential new avenues and targets for diagnostic and therapeutic applications.

For this latest paper, Kenny and Bissell looked into the pathway by which the EGFR signal is carried. EGFR, which stands for Epidermal Growth Factor Receptor, is the protein on the outer surface of a cell that is activated by EGF and related growth factors and signals for the cell to divide. Given that one of the hallmarks of cancer is cell division run amok, the reduction of high levels of EGFR activity has long been a primary target for anti-cancer drug development. So far, however, drugs aimed at directly inhibiting EGFR activity have met with only limited success in the cancer clinic, primarily in a small number of lung cancers.

"Because of this, we turned our attention to the processes that regulate the production of the ligands which bind and activate EGFR," Kenny said. "We reasoned that this binding and activation is essential for EGFR activation and that finding a way to block this interaction might prove to be an important additional approach to explore for inhibition of this pathway."

Earlier studies had indicated that TACE (tumor necrosis factor-alpha-converting enzyme) acts like a "molecular scissors" that releases from the cell surface a pair of ligands, called Amphiregulin and TGF-alpha, which activate EGFR. Bissell and Kenny found that by targeting TACE (also known as ADAM17) with either molecular inhibitors or short interfering RNAs (siRNAs) that silence the TACE gene, they could effectively block the shedding of Amphiregulin and TGF-alpha ligands. This resulted in the inhibition of EGFR signaling and the reversion of malignant characteristics in tumor cells. It is the first reported use of protease inhibitors to stop breast cancer cell proliferation and restore the normal breast tissue structure.

"We have designed an entirely new way of targeting EGFR signaling in breast cancer," said Kenny. "Almost all the work to date has involved the use of antibodies that stick to kinases or drugs that block kinase activities."

These newest results are very much in keeping with Bissell's contention that cancer growth and spread is not solely a tumor cell-autonomous process brought on by a genetic mutation. Bissell is one of the leading proponents of the idea that a cell's genetic information is supplemented by contextual information encoded within the microenvironment that surrounds the cell.

"It is becoming increasingly apparent that, as with other organs, the biogenesis of the tumor represents an interaction between the tumor cell, other types of cells and the rest of the microenvironment," she said.

Kenny and Bissell successfully tested their protease blocking approach on several different breast cancer cell lines. In addition, they examined the data from 295 breast cancer patients and found that tumors which produced the highest levels of TACE and the TGF-alpha ligand posed the greatest risk to women.

"Women with those types of tumors would seem to be poorly served by existing treatments and may stand to benefit from therapies that are based on the inhibition of TACE activity," said Kenny. "We would like to see some of the companies who have developed the new generation TACE inhibitors for treatment of rheumatoid arthritis also consider evaluating them in cancer patients."

Kenny stressed that the importance of EGFR to so many different tumor types, including lung, head and neck, bladder, colorectal and kidney, makes it likely that "TACE inhibition has the potential to be an effective means of stopping tumor growth for EGFR-dependent cancers outside the breast as well."

This research was supported by grants and a Distinguished Fellowship Award from the U.S. Department of Energy's Office of Biological and Environmental Research, the National Cancer Institute,and an Innovator award from the U.S. Department of Defense's Breast Cancer Research Program to Bissell, and by a Susan G. Komen Breast Cancer Foundation fellowship to Kenny.

Berkeley Lab is a U.S. Department of Energy national laboratory located in Berkeley, California. It conducts unclassified scientific research and is managed by the University of California. Visit our Website at http://www.lbl.gov/.

* For more information on the research of Mina Bissell and Paraic Kenny, please visit the Website at http://www.lbl.gov/lifesciences/BissellLab/main.html

Contact: Lynn Yarris
DOE/Lawrence Berkeley National Laboratory

YM BioSciences Provides Update On Tesmilifene Pivotal Trial

2007-04-15T11:37:00.001-07:00

YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced that the independent Data Safety Monitoring Board (DSMB) for the pivotal Phase III trial of tesmilifene in patients with metastatic or recurrent breast cancer has notified the Company that the milestone of 320 events required for the third interim analysis in its pivotal Phase III trial has occurred.

Since the last "data sweep" was completed in November 2006, the DSMB advised the Company to conduct a further data sweep to bring the survival data current prior to performing the third interim analysis. This data sweep is ongoing and the Company expects this work to be completed and to have a formal recommendation from the DSMB in February 2007. A data sweep is conducted on a periodic basis prior to each interim analysis.

"Although we are eager to learn the outcome of this third interim analysis, a meticulous review by the DSMB of any new data is entirely in keeping with the rigor of this trial," said David Allan, Chairman and CEO of YM BioSciences. "Because of the interest in this third analysis and expectations that it might occur this month, we decided to confirm that the threshold number of events has been reached. We have no additional information from this trial at this time."

The pivotal Phase III trial compares the survival of patients treated with tesmilifene combined with epirubicin/cyclophosphamide to epirubicin/cyclophosphamide alone in women with rapidly progressing metastatic and/or recurrent breast cancer. The trial, which completed enrollment of 723 patients in September 2005, is the subject of a Special Protocol Assessment and a Fast Track designation for advanced breast cancer by the FDA.

The trial is being conducted according to a sequential design that permits a number of planned interim analyses and the trial will continue until one of two specific statistical conditions is satisfied. At each analysis, the hazard ratio between the tesmilifene-containing treatment arm and the control arm is calculated and then reviewed by the DSMB. The trial may be concluded if either the tesmilifene-containing treatment arm is superior to the control by a specified margin or it is determined that such evidence is not going to be found. If the evidence is insufficient for either conclusion to be drawn, then the trial continues until the next analysis. At the first and second interim analyses, the DSMB recommended that the trial continue as planned.

About Tesmilifene

Tesmilifene is a novel, small molecule that selectively targets multiple-drug resistant (MDR) tumor cells, sensitizing them to chemotherapy. Tesmilifene may offer clinical benefit in a number of tumor types and is being tested with a variety of chemotherapeutic regimens. In addition to the current pivotal trial, a Phase III trial of tesmilifene with doxorubicin in metastatic or recurrent breast cancer has been completed and a Phase II study to evaluate tesmilifene plus docetaxel (Taxotere(R)) in patients with metastatic breast cancer is being conducted in collaboration with Sanofi-Aventis. In hormone-refractory prostate cancer (HRPC), two single-arm Phase II trials of tesmilifene in combination with chemotherapy (one with mitoxantrone plus prednisone; the other with cyclophosphamide) and a randomized Phase II trial comparing cyclophosphamide alone to cyclophosphamide plus tesmilifene have been conducted. Based on the clinical data generated from these three studies, the Company is currently evaluating additional clinical work in patients with HRPC. Clinical studies in other tumor types, including gastric and hepatic cancer, are also being planned.

About YM BioSciences

YM BioSciences Inc. is an oncology company that identifies, develops and commercializes differentiated products for patients worldwide. In addition to tesmilifene, the Company has two other late-stage products: nimotuzumab, a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR) and is approved in several countries for treatment of various types of head and neck cancer, and is in clinical trials in numerous tumor types including glioma (pediatric and adult), pancreatic cancer, prostate cancer, non-small cell lung cancer, esophageal cancer, cervical cancer and breast cancer; and AeroLEF(TM), a unique, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain.

This press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that the pivotal tesmilifene Phase III trial will be completed on schedule and yield mature data in calendar 2007; that the DSMB's recommendations to continue the pivotal trial for tesmilifene based on three planned interim analyses implies that the trial continues to have the prospect of meeting its primary endpoint; that nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; that YM and its various partners will complete their respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

YM BioSciences Inc.
http://www.ymbiosciences.com/

EU Red Tape Hampers International Cancer Trials

2007-04-15T11:34:00.001-07:00

European bureaucracy has made running large clinical trials for new cancer drugs more difficult, according to a Cancer Research UK report published in the European Journal of Cancer*.

The European Union Clinical Trials Directive was intended to harmonise standards across the continent, making it easier for international groups to collaborate. But because every member state implements European laws in a slightly different way, the effect has, in fact, been to increase costs, delay trials starting, and make collaboration more difficult.

Large-scale, multinational trials are the only way to prove the effectiveness of many anticancer drugs, especially those being developed for rare diseases, because of the large numbers of patients needed.

Dr Richard Sullivan, director of clinical programmes at Cancer Research UK and co-author of the report, said: "Our research confirms concerns that the introduction of the 2004 EU Clinical Trials Directive would delay and significantly increase the cost of cancer clinical trials in the UK. Critically, the legislation has also prevented the running of co-ordinated international trials by some trials units due to uncertainty over how each country in the EU is implementing the new rules - the very situation the Directive was intended to resolve. It is essential to provide proper funding for the academic trials community. A review of how the Directive is being implemented across member states is urgently needed."

* J. Hearn, R. Sullivan, The impact of the 'Clinical Trials' directive on the cost вЂ¦, Eur J Cancer(2006), doi:10.1016/j.ejca.2006.09.016. For further information click here.

About Cancer Research UK

Together with its partners and supporters, Cancer Research UK's vision is to beat cancer.

-- Cancer Research UK carries out world-class research to improve understanding of the disease and find out how to prevent, diagnose and treat different kinds of cancer.

-- Cancer Research UK ensures that its findings are used to improve the lives of all cancer patients.

-- Cancer Research UK helps people to understand cancer, the progress that is being made and the choices each person can make.

-- Cancer Research UK works in partnership with others to achieve the greatest impact in the global fight against cancer.

http://www.cancerresearchuk.org

Gonorrhoea Linked To Bladder Cancer In Men

2007-04-15T10:37:00.001-07:00

Men with a history of gonorrhoea have a two-fold increased risk of bladder cancer, according to a study published in the British Journal of Cancer*.

The study - led by researchers at the Harvard School of Public Health in the USA - is the first prospective study to confirm the link.

Bladder cancer is the fourth most commonly diagnosed cancer in UK men. Gonorrhoea is the second most commonly diagnosed bacterial sexually transmitted infection (STI) in the UK.

The paper comes from the Health Professionals Follow-Up Study - which has monitored the health of 51,529 men in the USA since 1986 through detailed questionnaires and medical records. The researchers identified 286 cases of bladder cancer for which complete information on gonorrhoea history was available.

Dr Dominique Michaud, Assistant Professor of Epidemiology at the Harvard School of Public Health and lead author on the paper, said: "Two studies have previously suggested a link between gonorrhoea and bladder cancer in men. But these were retrospective studies - meaning information on gonorrhoea history was gathered after the cancer was diagnosed. These studies can sometimes give misleading results. Gonorrhoea is an infection that often recurs, causing local inflammation and symptoms such as incomplete emptying of the bladder. The inflammation itself or the associated symptoms could be contributing to the development of bladder cancer. The severity and frequency of these symptoms may dictate the extent of the increased risk."

The researchers also found that a history of gonorrhoea increases the risk of invasive bladder cancer to a greater degree than superficial cancer. Patients with invasive cancer have a poorer prognosis.

Professor John Toy, medical director of Cancer Research UK, which owns the British Journal of Cancer, said: "This study strengthens the suspected link between infection with the gonorrhoea bacterium and bladder cancer in men. The next step is to confirm whether the increased risk could be caused directly by the gonorrhoea infection or its symptoms. Further research is also needed to exclude the possibility that gonorrhoea is acting as a marker for the real cancer-causing agent, such as a separate infection. A number of the biological processes that cause body tissues to become inflamed are also involved in the development of cancer, and scientists around the world are looking at how the inflammation might be causally linked to cancer in certain cases."

* Michaud, D. et al. (2007) British Journal of Cancer, Volume 96 Issue 1 - click here for more information.

Bladder cancer

Further information on bladder cancer and its treatment is available at CancerHelp and Cancer Research UK.

Around 10,150 people are diagnosed with bladder cancer in the UK each year, and more than 4,800 people die of the disease.

Smoking cigarettes is the principal preventable risk factor for bladder cancer in both men and women.

The highest incidence rates for bladder cancer are generally found in industrially developed countries, particularly in North America and Western Europe, and in areas associated with endemic schistosomiasis in Africa and the Middle East. In the UK bladder cancer is the fourth most common cancer in males, with 7,201 new cases diagnosed in 2003. This compares to 2,947 female cases, giving a male:female ratio of 5:2.

British Journal of Cancer (BJC)

The BJC's mission is to encourage communication of the very best cancer research from laboratories and clinics in all countries. Broad coverage, its editorial independence and consistent high standards have made BJC one of the world's premier general cancer journals.

About Cancer Research UK

Together with its partners and supporters, Cancer Research UK's vision is to beat cancer.

-- Cancer Research UK carries out world-class research to improve understanding of the disease and find out how to prevent, diagnose and treat different kinds of cancer.

-- Cancer Research UK ensures that its findings are used to improve the lives of all cancer patients.

-- Cancer Research UK helps people to understand cancer, the progress that is being made and the choices each person can make.

-- Cancer Research UK works in partnership with others to achieve the greatest impact in the global fight against cancer.

http://www.cancerresearchuk.org

Lung Cancer Vaccine Enters Large-scale Clinical Trial

2007-04-15T10:34:00.001-07:00

A new treatment for the most common form of lung cancer, developed from initial research by Cancer Research UK scientists, has entered a pivotal phase III clinical trial.

The drug, called Stimuvax, is a type of therapeutic vaccine that targets a specific protein found in many tumours, including non-small cell lung cancer. It was developed by Canadian biotech company Biomira following Cancer Research UK-funded studies led by Professor Joyce Taylor-Papadimitriou of Guy's Hospital, London. Biomira have already run phase II trials with very encouraging results.

The international phase III trial, named START (Stimulating Targeted Antigenic Responses To NSCLC), is expected to enrol its first patient this month. Run by pharmaceutical company Merck KGaA, it will eventually include more than 1,300 lung cancer patients in 30 countries, including the UK.

Therapeutic vaccines are a relatively new development in cancer treatment. Unlike preventative vaccines, they are treatments that induce the body's own immune system to identify and kill existing cancer cells. Stimuvax is designed to stimulate the immune system to recognise and react to a molecule called MUC1, which is much more abundant on tumour cells than healthy cells. The immune system then kills the cancer cells with MUC1, hopefully without overly harming healthy cells.

Cancer Research Technology Limited (CRT), Cancer Research UK's development and commercialisation company, licensed a number of discoveries to Biomira, which led to the development of Stimuvax for advanced non small cell lung cancer. Merck KGaA also plans to investigate the use of Stimuvax for other types of cancer.

Dr Keith Blundy, chief operating officer of CRT, said: "We are extremely pleased that Stimuvax has entered the final stage of clinical trials. The drug is one of CRT's portfolio of more than 20 partnered agents in clinical development. Targeted vaccines are an exciting approach that could potentially offer new treatment options for major types of cancer."

Harpal Kumar, chief executive of CRT and chief operating officer of Cancer Research UK, said: "We're delighted that another drug based on Cancer Research UK-funded basic research has reached the final stage of clinical development. The 'translation' of basic research into patient benefit is the major focus of our work and we hope that new ventures, such as the expansion of our drug discovery activities across the country, will lead to many more such drugs entering trials in the future."

Lung cancer

-- Lung cancer is the second most common cancer in the UK after breast cancer, and the most common cancer worldwide.

-- There were more than 37,000 cases of lung cancer diagnosed in the UK in 2003.

-- Non small cell lung cancer accounts for 80 per cent of total lung cancer cases.

-- Current standard treatments for lung cancer patients are surgery, platinum-based combination chemotherapy and radiotherapy.

START trial

In the trials, Stimuvax will be compared to a placebo. More information on the START trial can be found here.

Research centres in Edinburgh, Leeds and Exeter will be participating in the trial.

For more information about clinical trials in the UK, visit Cancer Research UK's patient information website, CancerHelp UK.

Cancer Research Technology

Cancer Research Technology Limited (CRT) is a specialist commercialisation and development company, which aims to develop new discoveries in cancer research for the benefit of cancer patients. CRT works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. CRT facilitates the discovery, development and marketing of new cancer therapeutics, vaccines, diagnostics and enabling technologies. CRT is wholly owned by Cancer Research UK, the largest independent funder of cancer research in the world. Further information about CRT can be found here.

About Cancer Research UK

Together with its partners and supporters, Cancer Research UK's vision is to beat cancer.

-- Cancer Research UK carries out world-class research to improve understanding of the disease and find out how to prevent, diagnose and treat different kinds of cancer.

-- Cancer Research UK ensures that its findings are used to improve the lives of all cancer patients.

-- Cancer Research UK helps people to understand cancer, the progress that is being made and the choices each person can make.

-- Cancer Research UK works in partnership with others to achieve the greatest impact in the global fight against cancer.

http://www.cancerresearchuk.org

Call For Better Prostate Cancer Biopsies

2007-04-15T09:37:00.001-07:00

Routine collection of additional information from prostate cancer biopsies could allow better decisions about the best choice of treatment, according to a study published in the journal Cancer*.

Through a systematic review of the published evidence, scientists funded by the NHS Cancer Screening Programme, Cancer Research UK and Cancer Research Wales found evidence of a link between the spread of cancer to nerves in the prostate gland - called 'perineural invasion' or PNI - and a poorer outlook for prostate cancer patients.

The clinical significance of PNI has been unclear, and therefore current guidelines for pathologists make no mention of PNI, leaving it up to individual doctors to decide whether they check for it or not.

This review shows a significant association between PNI and the risk of disease recurrence but the risk associated with PNI remains impossible to fully quantify from the few studies that have been done so far. The researchers are recommending to the Royal College of Pathologists that PNI should be assessed in every case of prostate cancer. This would help determine more precisely the size of the associated risk and so aid future decisions about treatment.

Prostate cancer is the most common cancer in men, with more than 32,000 cases diagnosed each year in the UK, but the best approach to treatment is not always clear. Doctors currently have very little evidence to rely on when deciding on the most appropriate treatment option.

Widespread use in the US of the PSA (Prostate-Specific Antigen) test to identify asymptomatic prostate cancer has led to an increase in the number of prostate tumours detected, but the PSA test gives only limited information regarding a patient's prognosis.

The best management of early diagnosed tumours is particularly hard to judge. Options include radical prostatectomy - surgical removal of the prostate - and active surveillance or so-called 'watchful waiting', which may be chosen on the basis that most prostate tumours are slow-growing and occur in elderly men in whom prostate cancer will not be their cause of death. If, however, the cancer turns out to be growing faster, then active treatment is offered.

Cancer Research UK's Dr Patricia Harnden, lead author of the report, said: "We've shown that PNI increases the risk of recurrence in prostate cancer. If it is found in a prostate biopsy, it could mean the difference between choosing 'watchful waiting' and immediately treating the cancer, or perhaps giving a longer course of therapy. Pathology is not being used to its full potential in prostate cancer if PNI is not looked for.

" Making PNI a mandatory reporting item in the guidelines of the Royal College of Pathologists would have two effects - it would help gather more data on the exact association between PNI and risk of recurrence, and it would enable doctors to make more informed decisions on how best to treat their patients. We must also ensure that future studies of pathological prognostic factors such as PNI are designed well enough to properly assess their significance."

Julietta Patnick, director of NHS Cancer Screening Programmes, said: "I am very pleased that the NHS Cancer Screening Programmes has been able to facilitate this significant work. The results of this review will assist health professionals in making the best treatment decisions for patients."

Professor John Toy, medical director of Cancer Research UK, said: "Some prostate cancer patients have normal PSA levels, and some healthy men have high PSA levels that are not caused by cancer. It can often be extremely difficult to predict with certainty the prognosis for many men with early prostate cancer.

"Therefore, the identification of a prognostic marker that indicates an aggressive cancer would be of great value. PNI in a prostate biopsy may be such a marker. We must ensure that no opportunity to gather potentially important information about prostate cancer is wasted."

Professor Adrian Newland, president of the Royal College of Pathologists, said: "The Royal College of Pathologists welcomes this systematic review of PNI in prostatic cancer biopsies, particularly the identification of PNI as a reliable predictor of adverse clinical outcome.

"Detailed histological evaluation by medically-trained histopathologists is essential in the assessment of cancer specimens, particularly the identification of features of clinical value to patients and their supervising clinicians alike. The Royal College of Pathologists endorses the view expressed in the paper that well designed studies using pre-defined stringent protocols are now required to provide robust objective estimates of risk, following identification of PNI in prostatic core biopsies, as an aid in the planning of treatment for men diagnosed with prostate cancer."

* Harnden et al. (2007) "The prognostic significance of perineural invasion in prostatic cancer biopsies: A systematic review" CANCER; Vol. 109 Issue 1, pp13-24

For more statistics on prostate cancer, please visit Cancer Research UK's CancerStats website.

The NHS Prostate Cancer Risk Management programme

-- Information on Prostate Cancer Risk Management, prostate cancer and the PSA test is available here.

-- For more information about the NHS Cancer Screening Programmes, contact Andrea Whitfield, Caroline Greenaway, Sarah Gibbs or Helen Ketton in the press office on 020 7025 7510 or email screening@westminster.com

About Cancer Research UK

Together with its partners and supporters, Cancer Research UK's vision is to beat cancer.

-- Cancer Research UK carries out world-class research to improve understanding of the disease and find out how to prevent, diagnose and treat different kinds of cancer.

-- Cancer Research UK ensures that its findings are used to improve the lives of all cancer patients.

-- Cancer Research UK helps people to understand cancer, the progress that is being made and the choices each person can make.

-- Cancer Research UK works in partnership with others to achieve the greatest impact in the global fight against cancer.

http://www.cancerresearchuk.org

Launch Of Queens Library Healthlink Initiative

2007-04-15T09:34:00.001-07:00

WHO:

Speakers: Borough President Helen Marshall; City Councilmember Helen Sears; Queens Library Director Thomas W. Galante; Dr. Robert Wittes, Physician-in Chief of Memorial Hospital; Alan Aviles, President of the New York City Health and Hospitals Corporation; Don Distasio, CEO of the American Cancer Society, Eastern Division; Anthony Tassi, Director of New York City Office of Adult Education

Guests: Tony Martin, Executive Director of Queens Hospital Center; Ann Sullivan, Senior Vice President of Queens Health Network

Entertainers: Jazz Band of Renaissance Charter School, Jackson Heights

WHAT: Launch of Queens Library HealthLink Initiative

WHEN: Wednesday, January 17, 2007, from 11:00am-12:00pm

WHERE: Queens Library at Jackson Heights, located at 35-51 81st Street in Jackson Heights.

***

DETAILS: This new initiative is a five-year, nearly $2 million dollar federally-funded collaboration among Memorial Sloan-Kettering Cancer Center, the American Cancer Society's Queens office, the Queens Library and the Queens Cancer Center of Queens Hospital.

The goal of this project, initiated by Memorial Sloan-Kettering Cancer Center, is to improve access to cancer screening and care in underserved communities The Queens Library HealthLink services will make available a Queens Health Network mobile cancer screening van that will visit community libraries; supply American Cancer Society educational programming at community libraries; provide free or low-cost cancer screening services through the New York State Healthy Living Partnership and furnish access to cancer treatment at the Queens Cancer Center regardless of ability to pay or immigration status.

The Queens Library HealthLink will:

* Build on the already strong relationships that the Queens Library has within the diverse neighborhoods it serves.

* Include 20 Queens Library community libraries that will join in the effort, serving as outlets for health outreach where they will partner and work closely with other organizations such as community agencies, religious institutions and local businesses.

* Provide links to information and health services through the American Cancer Society and at the Queens Cancer Center.

* Provide specialized staff with expertise in health and community organizing (HealthLink Specialists) to work with neighborhood residents to identify community health priorities and needs.

* Conduct surveys within the 20 participating library neighborhoods throughout the five-year project in order to measure the impact of Queens Library HealthLink programs.

###

Contact: Christine Hickey
Memorial Sloan-Kettering Cancer Center

Washington Post Reports On 'Growing Nationwide Effort' To Require HPV Inoculation For Middle-School Age Girls

2007-04-15T08:38:00.000-07:00

In the seven months since FDA approved Merck's human papillomavirus vaccine Gardasil, a number of states and Washington, D.C., have introduced legislation that would require middle-school age girls to receive the vaccine, and several other states have announced plans to make the vaccine available at no cost, the Washington Post reports (Harris/Levine, Washington Post, 1/12). Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. CDC's Advisory Committee on Immunization Practices in July 2006 voted unanimously to recommend that girls ages 11 and 12 receive the vaccine (Kaiser Daily Women's Health Policy Report, 1/10). Earlier this week, the Washington, D.C., City Council introduced a bill that would require girls to receive Gardasil before entering the sixth grade. Mayor Adrian Fenty on Thursday said he supported the legislation. Last week, similar bills were introduced in the Virginia General Assembly and the Maryland Legislature, the Post reports. Other states -- such as California, Kentucky, New Hampshire and South Dakota -- have introduced legislation that would either require the vaccine or make it available at no cost. State efforts to require Gardasil have been criticized by some groups that are concerned it "might encourage promiscuity or infringe on parents' authority over their daughters' health care," according to the Post. Other groups oppose it over general vaccine concerns. However, many groups support the proposals, most of which would allow parents or guardians to request and exemption, in the interest of public health, the Post reports (Washington Post, 1/12). The Texas Legislature also plans to consider two bills (SB 110, HB 215) that would require girls entering the sixth grade to receive Gardasil, but the measure would allow parents to apply for an exemption if they do not want their daughters vaccinated (Kaiser Daily Women's Health Policy Report, 1/9). According to the Post, almost 10,000 U.S. women are diagnosed with cervical cancer each year and about a third die from it. Minority and low-income women are disproportionately affected by the disease (Washington Post, 1/12).

Related Opinion Piece
"Everyone needs to take a deep breath, calm down and take a closer look at the 'cutting edge' [Washington, D.C.] proposal" that would require girls to receive Gardasil, Washington Times columnist Adrienne Washington writes in an opinion piece. Washington notes that critics' have said that the vaccine would increase sexual activity among young people or that the district proposal is a "sinister plot reminiscent of forced sterilization or mandatory birth control." She says the criticisms are "knee-jerk reactions [that] fail to look at the potentially lifesaving initiative for what it really is -- a public health issue, not a sexual or racial issue." District City Council member David Catania, who introduced the bill, "should be commended, not condemned for this proposal," Washington writes, concluding that the district should "not allow fear, passion or ignorance [to] sidetrack the necessary debate" (Washington, Washington Times, 1/12).

The kaisernetwork.org 'Ask the Experts' program, which aired on Wednesday and addressed implementation of Gardasil, is available online.

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

BioCryst Initiates Pivotal Fodosine(TM) Phase IIb Clinical Trial In Patients With Relapsed/Refractory T-Lymphoblastic Leukemia/Lymphoma

2007-04-15T08:35:00.001-07:00

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has initiated a pivotal trial of its lead oncology drug, Fodosine(TM), in the treatment of patients with relapsed or refractory T-cell leukemia/lymphoma. Initiation of this trial triggers a $5 million event payment from Mundipharma International Holdings Limited (Mundipharma) to BioCryst under the terms of the collaboration established in February, 2006 between the two companies to develop and commercialize Fodosine(TM), in markets across Europe, Asia, Australia and certain neighboring countries for use in oncology.

The multicenter, open-label, non-randomized, repeat-dose registration study will be conducted in accordance with a Special Protocol Assessment (SPA) agreement between the U.S. Food and Drug Administration (FDA) and BioCryst and will test a combination of intravenous and oral formulations of Fodosine(TM). Designed to determine the rate of complete remission achieved with this regimen of Fodosine(TM), the multinational trial will include sites in the United States, Eastern and Western Europe, and South America.

"This pivotal trial is based on the encouraging results we have seen in earlier studies of Fodosine(TM), including the positive data reported recently at the 2006 American Society of Hematology Annual Meeting," said J. Claude Bennett, M.D., Chief Operating Officer of BioCryst. "Those data indicated Fodosine(TM) is safe, well tolerated and effective as a single agent therapy and we believe Fodosine(TM) has the potential to be a valuable addition in the treatment of patients with T-cell mediated diseases."

Fodosine(TM) is a transition-state analog inhibitor of the target enzyme purine nucleoside phosphorylase (PNP). The drug is currently being studied in clinical trials for indications including T-cell leukemia (T-ALL), cutaneous T-cell lymphoma (CTCL), B-cell acute lymphoblastic leukemia (B-ALL) and chronic lymphocytic leukemia (CLL).

"The initiation of this pivotal study represents a major advancement in the company's efforts to bring Fodosine(TM) to market," said Jon P. Stonehouse, Chief Executive Officer of BioCryst. "There is a great need for new treatment options in T-cell mediated leukemias and lymphomas and we are working aggressively to enroll patients into this trial and advance this novel product toward commercialization in collaboration with our partner, Mundipharma."

Under the terms of the partnership, Mundipharma has committed to fund 50% of costs, up to $10 million, on current trials of Fodosine(TM) to be conducted by BioCryst, as well as an additional $15 million to assist in the evaluation of Fodosine's(TM) therapeutic safety and efficacy profile. Including the milestone reported today and as part of the original agreement with Mundipharma, BioCryst may receive future event payments totaling $155 million, along with royalties on product sales of Fodosine(TM) by Mundipharma. BioCryst retains all rights to commercialize and promote Fodosine(TM) in the United States, and other countries outside the scope of this agreement. BioCryst will owe sublicense payments to third parties on this event payment.

About Mundipharma

Mundipharma is one of the Purdue/Mundipharma/Napp independent associated companies - privately owned companies and joint ventures covering the world's pharmaceutical markets. The companies worldwide are dedicated to bringing to patients with severe and debilitating diseases the benefits of novel treatment options in fields such as severe pain, haemato-oncology and respiratory disease. For more information: http://www.mundipharma.co.uk.

About BioCryst

BioCryst Pharmaceuticals, Inc. is a leader in the use of crystallography and structure-based drug design for the development of novel therapeutics to treat cancer, cardiovascular diseases, autoimmune diseases, and viral infections. The company is advancing multiple internal programs toward potential commercialization including Fodosine(TM) in oncology, BCX-4208 in transplantation and autoimmune diseases and peramivir in seasonal and life- threatening influenza. BioCryst has a worldwide partnership with Roche for the development and commercialization BCX-4208, and is collaborating with Mundipharma for the development and commercialization of Fodosine(TM) in markets across Europe, Asia, Australia and certain neighboring countries. In January, 2007 the U.S. Department of Health and Human Services (DHHS) awarded a $102.6 million, four-year contract to BioCryst for advanced development of peramivir to treat seasonal and life-threatening influenza. For more information about BioCryst, please visit the company's web site at http://www.biocryst.com.

Forward-looking statements

These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include that DHHS could reduce or eliminate funding for peramivir, that we or our licensees may not be able to enroll the required number of subjects in planned clinical trials of our product candidates and that such clinical trials may not be successfully completed, that BioCryst or its licensees may not commence as expected additional human clinical trials with our product candidates, that our product candidates may not receive required regulatory clearances from the FDA, that ongoing and future clinical trials may not have positive results, that we may not be able to complete successfully the Phase IIb trial for Fodosine(TM) that is currently planned to be pivotal, that we or our licensees may not be able to continue future development of our current and future development programs, that our development programs may never result in future product, license or royalty payments being received by BioCryst, that BioCryst may not reach favorable agreements with potential pharmaceutical and biotech partners for further development of its product candidates, that BioCryst may not have sufficient cash to continue funding the development, manufacturing, marketing or distribution of its products and that additional funding, if necessary, may not be available at all or on terms acceptable to BioCryst. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, current reports on Form 8-K which identify important factors that could cause the actual results to differ materially from those contained in the projections or forward-looking statements.

BioCryst Pharmaceuticals, Inc.
http://www.biocryst.com

Vicus Therapeutics Announces The FDA Has Allowed The Phase 2 Trial Of VT-122 For The Treatment Of Cachexia In Patients With Advanced Lung Cancer

2007-04-15T07:34:00.000-07:00

Vicus Therapeutics, LLC, an oncology-focused, clinical-stage, biopharmaceutical company, announced today that the Division of Oncology Drug Products of the U.S. Food and Drug Administration (FDA) has determined that it is safe to proceed with the Phase 2 trial of VT-122. The compound will be tested for the treatment of cachexia in weight losing subjects with Stage IV, non-small cell lung cancer (NSCLC). The Phase 2 clinical trial will be conducted in the United States and India, and is expected to be completed in Q3 2007.

This multi-center, randomized, open-label controlled study will assess the safety and efficacy of VT-122 regimen administered to weight losing patients with Stage IV NSCLC. A total of 60 subjects will be enrolled in the study; 40 will be randomized to receive a defined nutritional support and VT-122 regimen (20 patients each receiving either of two doses of the first component and individualized maximum tolerated dose of the second component) and 20 patients receiving only the defined nutritional support. The primary endpoints of the study will be maintenance of muscle (lean body mass) and muscle function (grip strength). The study will also measure total body weight and quality of life. Assessments for safety and efficacy will be continued for 12 weeks. This trial will begin in February 2007 and data from this trial is expected to be available approximately six months after the trial is initiated.

"VT-122 is comprised of two FDA-approved drugs, each with an extensive set of safety data. Therefore, demonstrating efficacy and identifying the optimal dose during this Phase 2 clinical trial will be an especially significant step toward the development of VT-122," said John Maki, President and Chief Executive Officer of Vicus Therapeutics. "Treatment options for patients suffering from cachexia are very limited. There is currently no FDA-approved therapy for over 125,000 cancer patients in the United States who suffer from cachexia each year."

About Cachexia and VT-122

Cancer cachexia results in severe wasting of muscle and connective tissue and is one of the most common debilitating and distressing conditions of advanced cancer. Severe cachexia is associated with extreme weakness, intolerance to chemotherapy and substantially reduced life expectancy. Of patients who develop severe cachexia, approximately 50% have lung cancer. The size of this market has been estimated to exceed $250 million dollars.

VT-122 targets multiple inflammatory and other key pathways involved in the pathophysiology of cancer cachexia. The investigational product will be administered as an oral fixed dose combination, and is designed to block many of the biological targets necessary for cachexia persistence. Three investigator-led pilot trials with a total of seven evaluable subjects were completed in 2006. These trials demonstrated reversal of rapid weight loss in five subjects. No treatment related adverse events were reported.

About Vicus Therapeutics

Vicus Therapeutics is a privately-held, clinical-stage, biopharmaceutical company developing novel strategic approaches to the treatment of cancer supportive care indications. In addition to Vicus' lead program, VT-122, the Company has two preclinical programs for the treatment of oral mucositis and cancer fatigue. Vicus leverages its proprietary science to design and screen two-drug combinations that work together to reverse the body's maladaptive responses to cancer and its treatment. Vicus' development programs are powered by its network of leading clinical investigators in the United States, India and Japan. This global network drives the high quality, rapid and cost effective clinical development of Vicus' product candidates.

Vicus Therapeutics, LLC
http://www.vicustherapeutics.com

CEL-SCI Receives Green Light From FDA To Proceed With Phase III Cancer Study

2007-04-15T07:31:00.001-07:00

CEL-SCI Corporation (Amex: CVM), (Germany: LSR) today announced that the U.S. Food and Drug Administration (FDA) has stated in a letter to the Company that, "...the proposed Phase III study may proceed at any time." CEL-SCI's Phase III clinical study is designed to prove that its cancer drug Multikine(R) increases the survival of head and neck cancer patients.

The study is expected to be conducted in numerous countries around the world. It is designed to develop conclusive evidence of the efficacy of the Multikine treatment regimen in advanced primary squamous cell carcinoma of the oral cavity (head and neck cancer). Upon successful completion of this study, the data will be included in CEL-SCI's worldwide Marketing Applications to make Multikine commercially available for the treatment of this patient population. Head and neck cancer is an aggressive disease affecting about 500,000 people per annum worldwide.

Geert Kersten, Chief Executive Officer of CEL-SCI, said, "So far Multikine has been shown to be non-toxic, which is very unusual for a cancer drug. In Phase II clinical studies with head and neck cancer patients it also markedly increased survival. Now we will get the chance to prove that Multikine can extend the survival of these cancer patients."

The global Phase III study will test the hypothesis that the Multikine treatment regimen, administered locally prior to the current standard therapy given to patients with advanced primary squamous cell carcinoma of the oral cavity, will extend the overall survival and enhance the local/regional control of the disease, while increasing disease free survival in these patients.

Multikine is a patented immunotherapeutic agent consisting of a defined mixture of naturally occurring cytokines, including interleukins, interferons, chemokines and colony-stimulating factors.

CEL-SCI Corporation is developing new immune system based treatments for cancer and infectious diseases. The Company has operations in Vienna, Virginia and Baltimore, Maryland.

When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties, which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital, inability to get American Stock exchange approval for any transaction and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10- K for the year ended September 30, 2005. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date thereof or to reflect the occurrence of unanticipated events.

CEL-SCI Corporation
http://www.cel-sci.com

Update On Craniofacial Cancers

2007-04-15T06:36:00.001-07:00

The November/December issue of The Journal of Craniofacial Surgery presents a Special Section devoted to cancers of the head, face, and skull. Highlights include a review of giant congenital nevi, a relatively frequent problem that can pose a difficult challenge for surgeons; reports on a number of rare craniofacial cancers, including some unique challenges facing surgeons in non-Western countries; and some innovative treatment and reconstructive approaches.

Congenital nevi are birthmarks or moles that are present at birth small to medium-sized nevi are common and usually do not need surgery. However, a small percentage of infants have very large, or "giant" congenital nevi. These giant nevi have a high rate of transformation into malignant melanoma, an aggressive type of skin cancer.

Surgery to remove giant nevi avoids the risk of melanoma. However, the location and large size of the nevi make surgery highly challenging. The lead article in the special section highlights some of the other diseases and malformations that can be associated with giant nevi, as well as the along with the options for surgical treatment. Another article reports on the rapid development of a rare but very serious complication of giant congenital nevus, called neurocutaneous melanosis.

Other papers draw attention to rare or unusual cancers of the face, head, and neck. A study from Turkey reports on the evaluation and treatment of very large or extensive facial tumors some developing in patients who received no medical attention for many years. Although surgical reconstruction can achieve reasonably good results in such cases, "complex and long-lasting" operations should be reserved for younger patients, the authors believe. A group of Iranian surgeons describe the characteristics of cancers of the mouth in that country. They underscore the urgent need for efforts to improve early detection of oral cancers in Iran, since cancers diagnosed at an advanced stage are usually incurable.

Other studies report on rare conditions including nevus sebaceous of Jadassohn, a congenital lesion that is best recognized and removed early in life because of later cancer risk; and some rare complications of xeroderma pigmentosum, a condition that makes the skin highly sensitive to the damaging effects of ultraviolet radiation in sunlight.

The special section concludes with three reports on new scientific advances and techniques, including a study of the genetic effects of Medpor an artificial material used for bone reconstruction on bone-forming cells. Another study describes a new, gentler surgical approach to the difficult problem of removing tumors from the eye socket. The final paper reports on a new technique for preserving the colored part of the lip, or "vermilion border," for patients requiring surgery for tumors in that area.

"We hope the publication of this special section will help draw attention to some of the recent innovations and advances in the treatment of craniofacial cancers and encourage further work in this important area," comments Dr. Mutaz B. Habal, Editor-in-Chief of JCS.

About The Journal of Craniofacial Surgery

The Journal of Craniofacial Surgery serves as a forum of communication for all those involved in craniofacial and maxillofacial surgery. Coverage ranges from practical aspects of craniofacial surgery to the basic science that underlies surgical practice. Founded and edited by Mutaz B. Habal, MD, of Tampa, FL, the Journal is affiliated with major specialty societies worldwide, including the American Association of Pediatric Plastic Surgeons, the American Academy of Pediatrics Section of Pediatric Plastic Surgery, the American Society of Craniofacial Surgeons, the European Society of Craniofacial Surgery, the International Society of Craniofacial Surgery, the Japanese Society of Craniofacial Surgery, the Korean Society of Craniofacial Surgery, the Argentine Society of Plastic Surgery Section of Pediatric Plastic Surgery, the American Society of Maxillofacial Surgeons, the World Craniofacial Foundation, and the Brazilian Society of Craniomaxillofacial Surgery. Visit the journal website at http://www.jcraniofacialsurgery.com.

About Lippincott Williams & Wilkins

Lippincott Williams & Wilkins (http://www.LWW.com) is a leading international publisher for physicians, nurses, specialized clinicians, and students. Nearly 275 periodicals and 1,500 books in more than 100 disciplines are published under the LWW brand, as well as content-based sites and online corporate and customer services. LWW is part of Wolters Kluwer Health, a leading provider of information for professionals and students in medicine, nursing, allied health, pharmacy, and the pharmaceutical industry. Wolters Kluwer Health is a division of Wolters Kluwer, a leading multinational publisher and information services company with annual sales of в‚¬3.4 billion (2005) and approximately 18,400 employees worldwide.

Lippincott Williams & Wilkins
530 Walnut St.
Philadelphia, PA 19106
United States
http://www.lww.com

Transgenomic Inc. Launches Next Generation SURVEYOR(R) Mutation Detection Kits For Fluorescent Capillary Electrophoresis

2007-04-15T06:33:00.001-07:00

Transgenomic, Inc. (Nasdaq: TBIO) announced today that it is launching its next generation SURVEYOR Mutation Detection Kits for universal primer fluorescent capillary electrophoresis. The kits detect mismatch mutations in DNA that has been PCR amplified using two fluorescent primers and digested with SURVEYOR Nuclease. This then allows highly sensitive mutation detection on Applied Biosystems DNA sequencing instruments. It will be a key tool for scientists needing high-throughput analysis of genetic variation, even for those variations present at very low levels such as somatic mutations linked to cancer and its treatment.

Introduced by Transgenomic in 2004, SURVEYOR Nuclease is a proprietary mismatch-specific endonuclease that efficiently detects any mismatches in double-stranded DNA and cleaves at the site of DNA mutations. It identifies all base substitutions, insertions and deletions and can detect multiple mutations in a single fragment, in individual or even pooled PCR samples. SURVEYOR Nuclease's effectiveness in disease specific mutation discovery has been well documented in many peer-reviewed publications over the past two years.

In announcing the product launch, Craig Tuttle, Transgenomic, Inc. CEO, commented that, "We are excited to extend the SURVEYOR Mutation Detection Kit product line and provide such an important research tool to detect mutations that sequencing cannot find, or finds difficult to reveal. SURVEYOR also saves researchers time and money with its increased precision. SURVEYOR Endonuclease is an important expansion of Transgenomic's mutation detection product portfolio which is exemplified by our WAVE(R) System platforms and our emerging CLIA and GLP Clinical Reference Laboratory and Genomic Analysis and Research Services."

To find out more about SURVEYOR Nuclease, go to http://www.transgenomic.com

About Transgenomic: A decade of discovery 1997 - 2007

Transgenomic is a global biotechnology company that provides unique systems, products, discovery and laboratory testing services to the academic and medical research, clinical and pharmaceutical markets for automated high sensitivity genetic variation and mutation analysis in the fields of pharmacogenomics and personalized medicine. This is accomplished through their offerings of Wave(TM) DHPLC systems, reagents, consumables and assay kits, automated cytogenetics systems and Transgenomic Discovery and CLIA Lab Services. To date there have been over 1,200 Wave systems installed in over 600 customer sites in over 35 countries and approximately 1,500 publications utilizing Transgenomic products or services. Transgenomic Discovery and Lab Services utilize their technology and expertise to provide a menu of mutation scanning tests for over 700 cancer-associated genes and more than 60 validated diagnostic tests to meet the needs of pharmaceutical and biotech companies, research and clinical laboratories, physicians and patients. For more information about the innovative systems, products and services offered by Transgenomic, please visit: http://www.transgenomic.com.

Transgenomic Cautionary Statements

Certain statements in this press release constitute "forward-looking statements" of Transgenomic within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to management's current views and estimates of future economic circumstances, industry conditions, company performance and financial results, including the ability of the Company to grow its involvement in the diagnostic products and services markets. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in Transgenomic's reports to the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

Transgenomic, Inc.
http://www.transgenomic.com

Breast Cancer - A New Target For The Treatment Of Breast Cancer (Breast Cancer News)

2007-03-19T06:02:00.000-07:00

15 Common Myths About Cervical Cancer

2007-03-07T08:38:00.001-08:00

Destructive Enzyme Shows A Benevolent Side

2007-03-07T08:34:00.001-08:00

Designer Hens Lay Anti-Cancer Eggs

2007-03-07T07:38:00.001-08:00

Scripps Research Combination Therapy Obliterates New Vessel Growth In Tumors And Retinopathy

2007-03-07T07:33:00.000-08:00

Poniard Pharmaceuticals And The Scripps Research Institute Broaden Research Collaboration

2007-03-07T06:37:00.001-08:00

Washington, D.C., Bill Requiring HPV Vaccine Would Save 'Thousands' Of Women's Lives, Editorial Says

2007-03-07T06:33:00.001-08:00