February 28, 2007

Flaws In Cancer Clinical Trials Found

Cancer research and drug development are yielding more sophisticated candidate therapies, but investigators' methods to test them haven't kept pace, according to researchers at Memorial Sloan-Kettering Cancer Center. That could explain why so many experimental drugs fail in the final large and costly phase of testing, they say.

In the February 1 issue of Clinical Cancer Research the researchers found that only nine of the 70 Phase II studies they examined clearly defined measures by which an experimental drug could be judged to offer benefit to patients.

"We are facing a new and growing problem in clinical trial testing, and that is while the drugs have changed, researchers are still using the same old methods to gauge how effective they are," said the study's lead author, Andrew Vickers, Ph.D., a research methodologist.

The problem, Vickers said, is that for so long, therapies (usually chemotherapy) were tested by seeing if tumors would shrink in patients with advanced cancer. Measuring that reduction was an accepted way to gauge benefit, he said. But today's new treatments, which can include targeted therapies that slow tumor progression, are often tested in less advanced cancer and in combinations "and it can be hard to answer the question of whether patients are doing better than expected," he said.

In their study, Vickers, Howard Scher, M.D., Chief of the Genitourinary Oncology Service, and medical student Vennus Ballen, examined Phase II clinical trials reported from June 2003 - June 2005 in the Journal of Clinical Oncology or in Cancer, two major journals in cancer research. These studies, which usually enroll 30 to 50 patients, aim to provide a "go/no go" decision on whether the therapies studied should be evaluated in a large Phase III clinical trial, the ultimate test of whether a drug should be given to cancer patients.

They specifically looked at 70 studies whose design required "historical data" to determine whether a drug was promising enough to justify a Phase III trial. "When a novel agent is added to an existing standard in the hope of increasing response rates over and above those expected from the standard treatment alone, historical data on the response rates to the standard treatment are required," Vickers said. "Similarly, some agents are thought to slow disease progression, rather than lead to rapid tumor regression, necessitating an endpoint such as progression-free survival or overall survival at one year. That survival target clearly needs to be developed by reference to historical data."

For example, if two chemotherapy drugs used in combination lead to a 30 percent survival rate at one year, and researchers are interested in knowing whether an addition of a third drug is of benefit, the three-drug combination has to meet that 30 percent hurdle and jump over it, Vickers said. "So we have to be pretty certain that the 30 percent target is correct," he said.

Of the 70 studies they examined, however, nearly half (46 percent) did not give any justification for the historical target. And of the studies that did refer clearly to prior data, only a few (nine, or 13 percent), did so properly. Furthermore, trials that failed to report a rationale for the historical bar were much more likely to conclude that the new therapy was "active" and therefore worthy of further study or a Phase III clinical trial, Vickers said.

The researchers could not find a single study that used advanced statistical techniques to adjust for differences between patients studied in older clinical trials that were used as the historical bar and patients treated in the new trial, who may be at an early stage of cancer.

"These studies could have been done better", Vickers said. "Phase II studies are all about seeing whether patients on a new treatment are doing better than expected; if so, we should investigate the new treatment in a really big trial."

"However, to know whether we are 'doing better than expected' we need some kind of benchmark of what we should expect from standard treatment," Vickers said. "That benchmark assessment is what we find is missing from these studies."


The study was funded by the National Institutes of Health.

The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world's oldest and largest professional organization dedicated to advancing cancer research. The membership includes more than 24,000 basic, translational, and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and more than 70 other countries. AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special Conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment, and patient care. AACR publishes five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. Its most recent publication, CR, is a magazine for cancer survivors, patient advocates, their families, physicians, and scientists. It provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship, and advocacy.

Contact: Greg Lester
American Association for Cancer Research

Origin Of Brain Tumors Revealed By Genetic Fingerprints

Genetic fingerprints that reveal where a brain cell came from remain distinct even after the cell becomes a brain tumor, an international coalition of scientists report in the February 1 issue of Cancer Research.

The finding adds a new layer of complexity to the quest to understand the causes of childhood brain cancers, according to senior author David H. Gutmann, M.D., Ph.D., the Donald O. Schnuck Family Professor of Neurology at Washington University School of Medicine in St. Louis and co-director of the neuro-oncology program at the Siteman Cancer Center.

"Our findings suggest that brain tumors arising in different regions may be genetically distinct as a consequence of their unique cellular origins," Gutmann says. "This is yet another factor we need to consider when trying to understand how pediatric brain tumors form."

Researchers use information about tumor origins to develop new tests and treatments for the tumors. Brain tumors are the leading cause of cancer-related death in children, and the most common childhood brain tumor is the pilocytic astrocytoma (PA). Approximately 15 percent of all PAs are linked to neurofibromatosis 1 (NF1), a genetic condition that causes childhood brain tumors and is a primary focus of Gutmann's research. However, the genetic basis for the majority of PAs is unexplained.

In the new study, Gutmann led six laboratories in the most detailed genetic analysis of PAs to date.

"We were hoping to identify genes that contribute to the formation of these tumors and find indicators that might help us predict which tumors will be relatively well-behaved and which will be more aggressive," Gutmann says.

Previous studies have failed to produce any solid leads on the genetic alterations that predispose children to PAs.

"It should be recognized that the genetic alterations in this tumor may be very subtle," Gutmann notes. "When we looked at gene activity levels in the tumors as a function of brain location, though, a very interesting pattern began to emerge."

Cells in different parts of the brain carry the same genes, but they also contain factors that modify the use of those genes, suppressing some genes and activating others to allow the cells to take on specialized characteristics as the brain matures. These changes in gene activity levels are called changes in gene expression.

The researchers found that tumors arising in different regions of the brain retain distinct patterns of gene expression. These patterns provided genetic fingerprints or bar codes for the location of PAs, as well as for another glial cell tumor called an ependymoma. In addition, scientists also detected these distinct patterns of expression in normal glia and stem cells from these brain locations, suggesting that genetic fingerprints can be used to identify the potential origins of brain tumors.

"There's been a movement in recent years to link normal brain development to pediatric neuro-oncology, and these findings affirm that as a necessary approach," Gutmann says. "We won't fully understand the causes of pediatric brain tumors until we consider them in the context of factors that shape the development and specialization of different brain regions."

Sharma MK, Mansur DB, Reifenberger G, Perry A, Leonard JR, Aldape KD, Albin MG, Emnett RJ, Loeser S, Watson MA, Nagarajan R, Gutmann DH. Distinct genetic signatures among pilocytic astrocytomas relate to their brain region origin. Cancer Research, February 1, 2007.

Funding from Schnuck Markets, Inc.; Hyundai Motors; and 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.

Contact: Michael C. Purdy
Washington University School of Medicine

Pancreatic Cancer Stem Cells Identified By Scientists

Researchers at the University of Michigan Medical Center have, for the first time, identified human pancreatic cancer stem cells. Their work indicates that these cells are likely responsible for the aggressive tumor growth, progression, and metastasis that define this deadly cancer.

In the February 1 issue of Cancer Research, the researchers demonstrate that only 100 of these stem cells are needed to produce human pancreatic cancer in half of mice tested. They also found these cells are at least 100 times more tumorigenic than cancer cells that did not have one of three protein markers they believe to be associated with pancreatic cancer stem cells.

The findings could help advance development of new therapies for this cancer, which has a five-year survival rate of only three percent -- the worst prognosis of any major cancer, said the study's lead author, Diane M. Simeone, M.D., an associate professor of surgery and molecular and integrative physiology.

"The cells we isolated are quite different from 99 percent of the millions of other cells in a human pancreatic tumor, and we think that, based on some preliminary research, standard treatments like chemotherapy and radiation may not be touching these cells," said Simeone. "If that is why pancreatic cancer is so hard to treat, a new approach might be to design a drug that specifically targets pancreatic cancer stem cells without interfering with normal stem cell function."

While such a drug has not been developed, ongoing research suggests it is possible to do so, she added.

The study also advances the emerging notion that stem cells may lie at the heart of some, if not all, cancers, Simeone said. That theory suggests that only cells that have the properties of "stemness" -- that is, cells that can self-renew and differentiate into other types of cells -- are the only ones capable of producing tumors. These "cancer stem cells," could derive from normal adult stem cells in organs that have mutated, or from a differentiated cell that has devolved to take on the qualities of stem cells. They are resistant to traditional therapy designed for cells that rapidly turn over because stem cells don't, according to some researchers. Thus, they remain after tumors shrink and may be responsible for cancer recurrence and metastasis.

This study confirms at least one of those concepts, the researchers said. "Our study demonstrates that the very small subset of cells in a human pancreatic tumor that cause the cancer to grow and propagate have stem cell-like features," Simeone said.

To look for cancer stem cells in pancreatic cancer, the research team implanted cancerous tissue from human pancreatic specimens removed during patient surgery in "xenograft" mice with compromised immune systems. Researchers removed tumors after they grew, and then sorted millions of cancer cells to isolate those that had one or more of three surface protein markers -- CD44, CD24, and ESA. They chose these markers, called cell adhesion molecules, because they'd recently been found on isolated breast cancer cells by study co-authors Max Wicha, M.D., from Michigan and Michael Clarke, Ph.D., from Stanford University School of Medicine.

The researchers then implanted about 100 of each type of cell in mice, and found that tumors would grow in a subset of the animals, but cells that expressed all three markers were the most potent, producing tumors in six of 12 mice tested. If more cells are used, "we can get tumors to grow 100 percent of the time," Simeone said. "These cells are highly tumorigenic, which reflects the biology of this cancer."

Additionally, the tumors derived from the highly tumorigenic pancreatic cancer cells "appeared remarkably similar to the appearance of tumors taken directly from patients," Simeone said. The purported cancer stem cells produced a diverse mixture of cells, some of which are not cancerous, that reflected an actual human pancreatic tumor, she said.

The markers that define the highly aggressive pancreatic cancer subtype are not identically matched to those found in aggressive breast cancer, the researchers also discovered. The difference is in one marker, CD24, which is negative in breast cancer and positive in pancreatic cancer, according to Simeone.

"These studies suggest that several stem cell markers may be shared by cancer stem cells in different tumor types, such as CD44 and CD133, but it is possible that each tumor cancer stem cell has its own set of unique markers," Simeone said.


The study was funded by the Lustgarten Foundation, the Els Pardee Foundation, the Michgan Life Sciences Corridor, and the American Diabetes Association.

The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world's oldest and largest professional organization dedicated to advancing cancer research. The membership includes more than 24,000 basic, translational, and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and more than 70 other countries. AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special Conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment, and patient care. AACR publishes five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. Its most recent publication, CR, is a magazine for cancer survivors, patient advocates, their families, physicians, and scientists. It provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship, and advocacy.

Contact: Greg Lester
American Association for Cancer Research

Gut Research Yields New Anti-Cancer Approach

Researchers believe they have discovered by chance a new way to fight colorectal cancer, and potentially cancers of the esophagus, liver and skin. Early work shows that a group of compounds called peroxisome proliferator-activated receptor-gamma (PPARgamma) inhibitors may have an unexpected cancer-fighting effect, according to research published in the journal International Cancer Research. Furthermore, the new studies suggest that PPARgamma inhibitors act through some of the same mechanisms as the blockbuster chemotherapy Taxol, but with key differences.

While studying whether compounds known to affect PPARgamma could play a role in inflammatory bowel diseases, a team at the University of Rochester Medical Center found that medium-to-high doses of PPARgamma inhibitor killed colorectal cancer cell lines. Despite the compound's class name, the anti-cancer effect has nothing to do with the ability of the compounds to inhibit PPARgamma function. Researchers believe that PPARgamma inhibitors instead attack the "skeletons" of cancer cells that enable them to reproduce, grow and spread. Better solutions are needed because, according to the American Cancer Society, colorectal cancer remains the no. 2 cause of cancer death for men, and the no. 3 cause of cancer death for women.

"This is the first observation of a small molecule dramatically reducing levels of the proteins called tubulins, the building blocks of cancer cell skeletons," said Katherine L. Schaefer, Ph.D., a research assistant professor within the Department of Medicine, Gastroenterology and Hepatology Division, at the University of Rochester Medical Center, and first author of the paper. "Because cells that line the colon are similar to those in the liver, esophagus and skin, we see potential for a new way to treat those cancers as well."

In the study that led to the discovery of the anti-cancer effect, researchers were looking for new ways to reduce inflammation seen in Crohn's disease and ulcerative colitis, bowel diseases that cause pain and diarrhea. Specifically, they were comparing the effect on inflammation of encouraging the action of the PPARgamma protein (with activator compounds) against discouraging it (with inhibitors). The team conducted these experiments using colorectal cancer cells as study models because they arise from normal gut cells and share some of their qualities (e.g. normal inflammatory signals). Unlike normal gut cells, however, cancer cells do not die when removed from the gut wall. Living on in the absence of normal survival signals makes cancer cells dangerous in the body, but useful as cell lines for study.

While comparing PPARgamma activators and inhibitors, Schaefer noted with frustration that her cancer cells were dying before she could complete her experiments. Retracing her steps, she found that she had used too much inhibitor. The team, led by Lawrence J. Saubermann, M.D., associate professor of Medicine at the Medical Center, realized they had come across a potentially new therapeutic effect, and launched experiments to confirm it.

Study Details

In the newly published study, researchers observed the effects of three compounds known from the literature to inhibit PPARgamma, T0070907, GW9662 and BADGE, on the ability of colorectal tumor cells to survive. High doses (10-100 Г¬M) of all three interfered with colorectal cancer cell growth, reduced the cells' ability to spread through the bloodstream to cause new tumors elsewhere (metastasize) and caused cells to self-destruct, generally within 24 hours. Further experiments showed that high-dose PPARgamma inhibition destroyed cancer cell microtubules, protein structures that form part of the skeleton of cells.

Beyond providing structural support and shape to cells, microtubules expand and shrink to generate the force needed for cells to divide, a basic process in tumor growth. Microtubules are made of two related proteins, alpha and beta tubulin, which pair up to form a chain and then wind into a helix. The current studies found that high-dose PPARgamma inhibitors reduced levels of alpha and beta tubulin by 60 to 70 percent. Also described in the publication are studies where PPARgamma inhibitors killed tumor cells in mice without causing significant toxicity. That provides at least the hope that the drug class may not be prohibitively toxic in humans, the researchers said. More formal toxicity studies are underway.

While PPARgamma inhibitors reduce tubulin levels, older anti-microtubule drug classes; Vinca alkaloids, taxanes (including Taxol) and epithiolones; interfere with microtubule dynamics. To play their role in tumor growth, microtubules must remain flexible. Taxol, for example, "freezes" tubulin subunits, making the cell skeleton rigid and unable to make the shape changes necessary for cell division. Brought to the market by Bristol-Myers Squibb in 1993, Taxol had annual sales of $1.6 billion at its peak in 2000.

Unfortunately, Taxol and other standard, anti-tubulin drugs failed in colorectal cancer clinical trials. Gut tumor cells have evolved to include "efflux" proteins that recognize standard chemotherapies as foreign, and "pump them out" of tumor cells. Even for breast and lung cancer, the tumor types for which Taxol is most used, nearly 100 percent of these tumors eventually become resistant, said Alok A. Khorana, M.D., assistant professor of Medicine at the Medical Center. In cells with more drug efflux pumps, Taxol is not effective (e.g. pancreas, liver and colon), he said.

High-dose PPARgamma inhibitors may overcome the limits of current treatment because the profile of molecules likely to be pumped out by drug efflux proteins is known, and at least one of the PPARgamma inhibitors does not match it. In addition, PPARgamma inhibitors do not bind to the standard tubulin-binding site that renders Taxol useless when binding sites change shapes thanks to ongoing genetic mutations.

With standard anti-microtubule not an option for colorectal cancer, current chemotherapy regimens feature 5-fluorouracil (5-FU) in combination with other chemotherapy drugs (oxaliplatin, irinotecan) and antibodies (bevacizumab, cetuximab). Once again, response rates of current drugs are low (less than 30 percent as single agents). Tumors generally begin growing again with a year.

Moving forward, the research team will seek to determine exactly which proteins are involved in the anti-cancer effect of PPARgamma inhibitors. Combination therapy is the current leading strategy in treating cancer, and finding the mechanisms by which PPARgamma inhibitors work could be a first step toward their safe combination with other treatments.

"The last work attempting to reduce tubulin levels was abandoned approximately 25 years ago under the assumption that such drugs would be toxic, destroying microtubules in healthy cells as well as cancer cells," Schaefer said. "Our early studies, however, suggest that general toxicity does not rule out this approach as once feared. With new drug delivery technologies that help drugs target only cancer cells, we are very excited about the potential of this line of work."


Contact: Greg Williams
University of Rochester Medical Center

The Psychology Of Skin Cancer

Thousands of people are jetting off for a week of sun, snow, and aprГЁs-ski. And while they may worry about breaking limbs, how many consider the dangers of skin cancer?

It is one of the most common cancers in the UK, with more than 69,000 new cases reported every year. The incidences of the most dangerous type - melanoma - have has doubled over the past 20 years.

Now an online survey aims to learn how people of different nationalities behave while having fun in the sun, and their attitudes to tanning and skin cancer.

The survey, at www.genomel.org, is the latest initiative by GenoMEL, a five-year international research consortium, coordinated by the University of Leeds, which is using a combination of genetic science and psychology to try and halt the alarming rise in skin cancers.

Their main focus of the researchers is collecting DNA from thousands of people, to identify the genes - running in families or populations - which may increase susceptibility to skin cancer. The project coordinator is Professor Julia Newton-Bishop of the Leeds Institute of Molecular Medicine. She explained: "We have identified four high-risk melanoma genes which increase someone's risk of skin cancer. There are also many other relatively low-risk genes, such as MC1R, - this one which gives people pale skin, red hair and freckles and therefore makes them more susceptible to sun damage."

But it isn't simply genetic. For example, in Australia up to 11 per cent of melanoma patients report an earlier family history of the disease, compared to just one per cent in the UK, although both countries have a similar genetic mix. Susceptibility to cancer may be related to lifestyle, where you live - and how you look after yourself in the sunshine.

The multiple-choice survey aims to show how lifestyle choices and attitudes to exposure to the sun affect the risk of getting skin cancer. It takes between 20 and 30 minutes to complete and offers participants the chance to access receive more information about reducing their own risk.

"This is a great way for people to take part in research and to really make the most of the Internet," said Professor Newton-Bishop. "With an on-line survey we can involve thousands of people whereas with more traditional methods we could only reach a few hundred."

The questionnaire is available in English, Dutch and Swedish - though French, Spanish, Italian, German, Slovenian, Hebrew, Polish and Latvian versions of the site will go live over the next few months, allowing researchers to assess how people of different nationalities interpret their own risk and protect themselves in the sun.

The results, expected in early 2008, will help scientists develop more effective prevention and education strategies, aimed at getting millions of sun worshippers to change their behaviour. Professor Newton-Bishop added: "We hope to create an online 'risk calculator' that makes it easy for individuals of different skin types to work out how safe they are in the sun, based on our genetic research findings."


Melanoma accounts for almost three per cent of all newly diagnosed cancers each year in the UK. Every year there are about 3,500 new cases of melanoma in men, and over 4,500 new cases in women. In 2004 over 1,700 people died from melanoma in the UK.

GenoMEL, funded by a ВЈ7m grant from the European Commission, started in December 2005, and runs until 2010.

The Cancer Research UK website www.cancerresearchuk.org offers information about melanoma.

For further information, please contact:
Project Manager Paul Affleck

Contact: Simon Jenkins
University of Leeds

Mayo Clinic Chest Surgeons Propose New Patient-Centered Measures For Indicating Quality Of Lung Surgery

In an era when lung cancer remains the most lethal cancer, accounting for more deaths than colon, breast and prostate cancer combined -- and surgery, when possible, is the most effective treatment -- Mayo Clinic surgeons have proposed a system of lung surgery quality indicators for surgeons and the public as a method to demonstrate best practices for obtaining positive patient outcomes.

Mayo Clinic surgeons believe the process is necessary because no other method currently exists to measure the quality of care received by patients undergoing lung surgery.

Death rates following surgery are reported. However, because they aren't adjusted for factors such as patient age and disease severity, they don't tell the whole story. To overcome this lack of risk adjustment in death rate data, the Mayo Clinic team proposed patient-centered processes that should occur prior to, during and after surgery to assure the likelihood of best surgical outcomes.

"There are certain processes that we can measure and report that clearly indicate whether a patient has received high-quality care around the time of their lung operation," explains Stephen Cassivi, M.D., Mayo Clinic thoracic surgeon. Dr. Cassivi presented a list of proposed patient-centered quality indicators for lung surgery at the 43rd Annual Meeting of the Society of Thoracic Surgeons this week in San Diego. "Knowing this data can help the patient decide about the care they are about to receive and where to go to receive that care -- and equally important, this knowledge can help chest surgery programs improve their quality of care by concentrating on identified weaknesses," says Dr. Cassivi. "Creating standards through measures of process will allow for directed quality improvement initiatives across all surgical centers."

The Mayo Clinic List of Quality Indicators

To find the clearest and most meaningful measures to evaluate lung surgery quality, the Mayo Clinic team analyzed the care of 606 lung surgery patients who underwent 628 lung surgeries at Mayo Clinic during one year. The patients' average age was 65.8 years and ranged from 2 to 93 years.

From the analysis, the following list emerged for processes that should occur prior to surgery because of their potential contribution to positive patient outcomes.

-- Pulmonary function testing

-- Electrocardiogram

-- Smoking history documented

-- Smoking cessation therapy offered to those patients still smoking prior to surgery

-- Appropriate preoperative staging of cancer

In addition, the Mayo Clinic team identified post-lung surgery practices that improve patient outcome. These include: use of incentive spirometry -- a simple breathing exercise meant to increase lung capacity and prevent postoperative pneumonia; timely response to heart rhythm disturbances; defined measures to prevent venous clots (deep vein thrombosis); documented timely attention to pain control for patients' comfort; and follow-up care planning with the patient prior to discharge from the hospital.

"All of these measures are patient-centered and relevant to the clinical improvement of the patient undergoing lung surgery, and they can be easily documented and assessed," Dr. Cassivi says. The Mayo Clinic thoracic surgery team suggests that surgeons and hospitals adopt them as standard protocol.

The Next Step

Mayo Clinic will work to formalize its proposal with the Society of Thoracic Surgeons. Adopting these quality process measures as standards and compiling data regarding adherence to these standards could be accomplished using the Society of Thoracic Surgeons national general thoracic surgery database.

Says Dr. Cassivi: "Our Mayo Clinic experience shows that if the whole general thoracic surgery team -- from surgeons, to nurses, nurse educators, physician assistants, physical therapists -- uses these process measures as indicators of a high quality of care, areas for improvement can be identified and improved in a timely fashion. If all practices used these indicators, the huge variability in care of lung surgery patients could be reduced and overall quality increased."

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. For more on Mayo Clinic research, go to http://www.mayo.edu.

Mayo Clinic

Texas Governor Perry Stands Firm On HPV Vaccination Mandate For Schoolgirls

Texa Governor Rick Perry stands firm against the opposition to his executive order to vaccinate schoolgirls against HPV, making Texas the first state to mandate the vaccination. He said he is for "protecting life". Last year the Food and Drug Administration (FDA) approved the vaccine for use against cervical cancer, which kills nearly 4,000 women a year in the US.

Republican State Senators Jane Nelson (for Grapevine, Texas) and Jim Keffer (for Eastland, Texas) said their phone lines had been ringing all day Monday with parents complaining about the governor's order.

Senator Nelson, who chairs the Senate's committee on Health and Human Services, criticised the speed with which the decision was taken, saying that it was not an emergency situation and decisions like this should be discussed and debated. She said that patients, experts and doctors should have had a say in it. Other critics are saying this was not a decision for the governor, it should have come through the legislature. In Texas, a Governor's executive order effectively bypasses the normal law-making process.

The Governor's action has been welcomed by many women's groups but the parents who are complaining say that the decision inteferes with parenting and will encourage girls to have sex early.

Governor Perry, a Republican and conservative Christian who stands against abortion and embryonic stem-cell research, disagrees that the vaccine will encourage promiscuity any more than the Hepatitis B vaccine encourages people to take drugs, and he challenged the critics by asking them if they would oppose a cure for lung cancer on the grounds that it might encourage people to take up smoking. He said the goal was the same as the polio vaccination campaign, to save lives.

Following the executive order, from autumn 2008, all girls going into sixth grade (age 11 - 12) will start the vaccination programme, which comprises three doses of Gardasil, (made by Merck and Co) over a 6 month period. The cost is around 360 US dollars and is covered by most insurance plans.

In order to maximise the coverage of the vaccination programme in Texas, the Governor has ordered that the vaccine will be free for girls aged 9 to 18 who are either not insured or not covered for the vaccine. And Medicaid will be required to offer it to women from 19 to 21 years old too.

Parents who wish to opt out of the programme have to file an affidavit, giving religious or philosophical grounds for their objection. This is the same as for any other compulsory vaccination such as those against mumps and measles.

There are over 100 types of HPV (human papillomavirus), of which around one third are sexually transmitted and shown to cause about 70 per cent of cervical cancer cases. The Centers for Disease Control (CDC) say that the HPV vaccine has no serious side effects, as proven by a clinical trial on 11,000 women aged between 9 and 26.

This week brings news that Florida lawmakers want to introduce legislation that would also make it compulsory for girls to be vaccinated against HPV before they become sexually active. The proposal is said to have the backing of both Democrats and Republicans. Some 20 other states are also considering doing the same. Texas is the only state so far to have bypassed the lawmakers by going down the executive order route.

Click here for more information about HPV infection (CDC).

Written by: Catharine Paddock
Writer: Medical News Today

Researchers Earn $200,000 Prize For Filtering Arsenic From Water Wells

An international team of engineers led by Lehigh Prof. Arup SenGupta has won a $200,000 prize for its efforts to counter what some people have called the world's worst environmental catastrophe.

The researchers, who have designed a system that filters arsenic from well water, will receive the Silver Award in a contest sponsored by the National Academy of Engineering (NAE) and The Grainger Foundation.

The awards were announced by NAE and will be presented at the 2007 NAE Awards Dinner on Tuesday, Feb. 20, in Washington, D.C.

The 2007 Grainger Challenge Prize for Sustainability sought innovative solutions for removing arsenic from drinking water. Of the 70 teams submitting entries, three won prizes. The NAE, a private, nonprofit institution, advises the federal government and conducts engineering studies. The Grainger Foundation supports education, museums, health care and human services.

The World Health Organization estimates that as many as 100 million people in India and Bangladesh may be drinking well water that contains toxic levels of arsenic. Victims suffer skin lesions, cancer and even death. WHO calls the phenomenon the "largest mass poisoning of a population in history."

"Cupful by cupful, the people of Bangladesh and other developing countries are being poisoned by drinking water from tube wells," says the Grainger Challenge website. "Tens of millions of Bangladeshis - as many as a quarter of the total population - use wells that provide water containing 10 to 50 times the amount of arsenic considered safe." Bangladesh has a population of about 140 million.

SenGupta, the P.C. Rossin Professor of civil and environmental engineering and also of chemical engineering, was asked in 1995 by the nonprofit organization Water For People to design an arsenic-removal system. An expert in the removal of trace contaminants, SenGupta has taught and consulted in Turkey, the United Arab Emirates, Japan, Germany and Ecuador.

SenGupta will share the Grainger Challenger Silver Award with Water for People and also with John Greenleaf, a Ph.D. candidate in environmental engineering; Lee Blaney '05, a graduate student in environmental engineering; Owen E. Boyd, CEO of SolmeteX Co. in Northborough, Mass.; and Arun K. Deb, retired vice president of Weston Solutions Inc. in West Chester, Pa. Sudipta Sarkar, a post-doctoral associate in SenGupta's laboratory, and Prasun Chatterjee, a doctoral student in the environmental engineering program, also contributed significantly to the Grainger Challenge project.

SenGupta's laboratory is credited with developing and commercializing the first polymer-based arsenic-selective adsorbent. Working with Luis Cumbal, who earned a Ph.D. in environmental engineering from Lehigh in 2004, SenGupta learned to "impregnate" columns of tiny, polymeric ion-exchange beads with ferric hydroxide nanoparticles. The iron transmits its affinity for arsenic to the beads. The beads provide a sturdy mechanism for the fine iron powder, which would otherwise clump and clog the column, making arsenic removal inefficient or impossible. The result is a hybrid sorbent that removes arsenic from water.

The hybrid sorbent is employed in the Indian subcontinent and in more than 200 sites in the U.S. to remove arsenic from contaminated groundwater.

In Eastern India since 1997, SenGupta's filtration systems have been installed in 150 villages by students and professors from Bengal Engineering and Science University. Arsenic levels in the villages' drinking water have fallen from 100 to 500 parts per billion to well below the 50 ppb maximum allowed by the Indian government. Victims have found relief from their symptoms, and reports of new cases of arsenicosis have plummeted.

Each filtration system is built in India. Cost of installation ranges from $1,200 to $1,500 and is usually paid by villagers. The systems are operated with a hand pump and require no electric power or chemicals. They are maintained by village committees with help from Bengal Engineering and Science University.

Recent history, says SenGupta, suggests that solutions to the environmental problems of developing countries, when imposed "top-down" from outside, can cause as much harm as good.

The residents of Bangladesh and Eastern India once obtained their drinking water from rivers, streams and ponds polluted with human and animal waste. Cholera, typhoid, diarrhea and other water-borne diseases killed hundreds of thousands of people each year.

In the 1970s, UNICEF and other aid agencies helped the government of Bangladesh build tube wells to tap underground aquifers whose water was presumed to be safe for drinking.

It was not until 1994 that toxic levels of arsenic were discovered in the wells, SenGupta says. (Arsenic is not present in the region's surface water, he adds.) The arsenic was not generated by human activity, and scientists have not yet determined its origin.

"We do not know how long the arsenic has been in the groundwater," says SenGupta, who is a native of Eastern India. "We do not know why we find it in one township and not the next, and why we sometimes find it in one well but not in another well located just 100 meters away."

In 2002, writing in the Journal of the Institution of Chemical Engineers, of which he was international editor, SenGupta said, "Our attempts to solve the environmental woes of the 'developing' countries with solutions from the 'developed' ones have often been unsatisfactory, if not disastrous."

In 2005, SenGupta and his colleagues from Bengal Engineering and Science University received the Mondialogo Engineering Award for their arsenic- removal efforts in a contest sponsored by Daimler-Chrysler and UNESCO.

The $1-million Gold Award in the NAE-Grainger contest was won by Abul Hussam, associate professor of chemistry and biochemistry at George Mason University in Fairfax, Va., who developed a household water treatment system called the SONO filter. The $100,000 Bronze Award will go to Procter & Gamble Co.'s Children's Safe Drinking Water Program for a coagulation and flocculation water treatment system.


SenGupta's collaborators at Bengal Engineering and Science University include Dr. Anirban Gupta and Debabrata Ghosh.

SenGupta currently holds five U.S. patents for inventions related to environmental processes.

Contact: Kurt Pfitzer
Lehigh University

Agendia Receives U.S. FDA Clearance For MammaPrint Breast Cancer Diagnostic Test

Agendia announced today that the U.S. Food and Drug Administration (FDA) has cleared the company's MammaPrint(C) breast cancer diagnostic test. MammaPrint(R) is a gene expression profiling service to assess the risk of recurrence in breast cancer patients. MammaPrint(R) represents a U.S. regulatory milestone as the first In Vitro Diagnostic Multivariate Index Assay (IVDMIA) to acquire market clearance from the FDA, and is the agency's first step toward standardizing these multi-gene expression tests.

"Today's FDA clearance of MammaPrint(R) is a milestone for patient care and safety," said Dr. Bernhard Sixt, Chief Executive Officer at Agendia. "As the first test of its kind cleared by the FDA, this type of regulatory review benefits breast cancer patients and provides regulatory clarity to the medical community. At present, MammaPrint(R) is the first cleared IVDMIA which can be marketed in the US in compliance with these new FDA guidelines. We are exploring ways to make this product available in the US."

"We are pleased about today's FDA announcement as it signifies an important first step in standardizing IVDMIAs to ensure a safe and welcomed advancement in cancer diagnostics," said Diane Blum, MSW, Executive Director of CancerCare.

This week, the FDA will hold a public hearing to discuss draft guidance developed by the agency regarding IVDMIAs. The FDA intends to regulate multi- gene molecular diagnostics tests that meet specific criteria to ensure maximum safety and efficacy, as well as to ensure IVDMIA results can be easily interpreted by physicians.

About Agendia BV

Agendia, located in Amsterdam, the Netherlands, is a world leader in gene expression analysis-based diagnostics with three products on the market. The company focuses on the development and commercialization of diagnostic tests using tumor gene expression profiling. Agendia maintains close ties with several leading European academic centers to develop state of the art diagnostic tests for cancer. Agendia also offers its expertise to pharmaceutical companies focusing on development of highly effective personalized drugs in the area of oncology.

More information about Agendia BV and MammaPrint is available at http://www.agendia.com

Agendia BV

EMEA Grants Orphan Drug Designation To BioCryst's Fodosine(TM) For The Treatment Of Cutaneous T-Cell Lymphoma (CTCL)

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that Fodosine(TM) has been granted orphan status for the treatment of cutaneous T-cell lymphoma (CTCL), by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA).

This is the second indication for which the EMEA has granted orphan drug status to Fodosine(TM) following regulatory submissions by Mundipharma, BioCryst's European Fodosine(TM) partner. In November 2006, the EMEA granted orphan drug designation to Fodosine(TM) for the treatment of T-cell acute lymphoblastic leukemia (ALL).

Fodosine(TM), BioCryst's lead oncology candidate, is currently being studied in clinical trials for indications including T-cell acute lymphoblastic leukemia (T-ALL), cutaneous T-cell lymphoma (CTCL), B-cell acute lymphoblastic leukemia (B-ALL) and chronic lymphocytic leukemia (CLL). In January 2007, BioCryst initiated a pivotal phase IIb clinical trial with Fodosine(TM) in the treatment of patients with relapsed or refractory T-cell leukemia/lymphoma.

The EMEA's "Orphan Medicinal Product Designation" is designed to promote the development of drugs, which may provide "significant benefit" to patients suffering from rare diseases identified as "life-threatening or very serious." Under EMEA guidelines, Orphan Medicinal Product Designation provides 10 years of potential market exclusivity if the product candidate is approved for marketing in the European Union. Orphan status also permits EMEA assistance in optimizing the candidate's clinical development through participation in designing the clinical protocol and preparing the marketing application. Additionally, a drug candidate designated by the EMEA as an Orphan Medicinal Product may qualify for a reduction in regulatory fees as well as a European Union-funded research grant.

"The EMEA's decision to grant Fodosine(TM) orphan drug designation for the treatment of patients with CTCL signifies another important step for BioCryst and Mundipharma in our development of Fodosine(TM)," said Jon P. Stonehouse, CEO of BioCryst. "This action by the EMEA reinforces our belief that Fodosine(TM) has worldwide potential to become an important treatment alternative for patients with this debilitating disease."

In 2005, the United States Food and Drug Administration (FDA) granted Orphan Drug designation to Fodosine(TM) for three indications: T-cell non- Hodgkin's lymphoma, including CTCL; CLL and related leukemias including T-cell prolymphocytic leukemia, adult T-cell leukemia, and hairy cell leukemia; and for the treatment of B-ALL. Additionally the FDA has granted "fast track" status to the development of Fodosine(TM) for the treatment of relapsed or refractory T-cell leukemia.

About Fodosine(TM)

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 acute lymphoblastic leukemia (T-ALL), cutaneous T-cell lymphoma (CTCL), B-cell acute lymphoblastic leukemia (B-ALL) and chronic lymphocytic leukemia (CLL).

In early 2006, BioCryst entered into a strategic collaboration with Mundipharma International Holdings Limited to develop and commercialize Fodosine(TM) in markets across Europe, Asia, Australia and certain neighboring countries for use in oncology.

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 of 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.


Spectrum Pharmaceuticals Announces Completion Of Patient Accrual In Its EOquin(R) Pilot Study, Prior To Initiating Phase 3 Studies In The U.S.

Spectrum Pharmaceuticals (Nasdaq: SPPI) announced today that the Company has completed patient accrual in the U.S. pilot safety study of EOquin(R) in patients with noninvasive bladder cancer. In this study, EOquin(R) was found to be well tolerated when administered to patients immediately following surgery for noninvasive bladder cancer in clinical results to date.

The pilot study was a multicenter, single-arm, open-label study. Twenty patients received 4 mg of EOquin(R) in 40 mL of diluent. EOquin(R) was instilled via an indwelling catheter that was then clamped for one hour. After an hour the bladder was drained and the catheter was removed. Patients were assessed for adverse events during the one-hour retention and at follow-up visits on postoperative days eight and 15. Wound healing was assessed by cystoscopy performed at postoperative day 85. In six patients, systemic absorption, if any, was assessed by measuring the blood levels of EOquin(R) and its metabolites. Results confirmed previous clinical results where EOquin(R) administration was well tolerated. In addition, there was no adverse effect on wound healing and when administered immediately after surgery, EOquin(R) was not absorbed into the bloodstream.

"We are pleased with the results of this study, that was requested by the FDA, which demonstrate that EOquin is well tolerated and does not affect surgical wound healing and is not systemically absorbed even when given immediately after surgery; we therefore will not expect side effects outside of the bladder. We look forward to finalizing the Phase 3 protocol, which has been submitted to the FDA for a Special Protocol Assessment. We expect to initiate the Phase 3 studies before mid year," stated Luigi Lenaz, M.D., Chief Scientific Officer of Spectrum Pharmaceuticals. "Bladder cancer is a difficult and expensive disease to treat, and we believe that EOquin(R) has the potential to make a difference in the lives of bladder cancer patients."

Spectrum anticipates full data from the completed pilot study to be presented at a scientific conference in the coming months.

About EOquin(R)

EOquin(R) (apaziquone for intravesical instillation) is a drugВґ currently being developed for the treatment of noninvasive bladder cancer, cancer that has not invaded the muscle of the bladder wall. EOquin(R), an anti-cancer agent that becomes activated by reductase enzymes found in cancer cells, is formulated for administration directly into the urinary bladder. In studies performed to date, EOquin(R) was not absorbed in any significant amount from the bladder wall into the bloodstream and would carry a lesser risk of harming the rest of the body.

Spectrum Pharmaceuticals completed multi-center, Phase 2 clinical trials in Europe. The results of the trial were favorable, showing that EOquin(R) was safe and efficacious. These data were presented to the FDA in early 2006.

About Bladder Cancer

The American Cancer Society estimates that there were more than 61,420 new cases of and 13,060 deaths from bladder cancer in 2006 in the United States. The estimated patient population with bladder cancer is over 400,000 in the United States and even greater in Europe. Noninvasive bladder cancer accounts for 75 to 80 percent of all cases of bladder cancer at first diagnosis. According to Botteman et al., (PharmacoEconomics 2003), bladder cancer is the fifth most expensive cancer to treat. The initial treatment of this cancer is surgical removal of the tumor. Because of the high frequency of early recurrences of the tumor, many current practice guidelines recommend immediate instillation of a chemotherapeutic agent after surgery for which there is currently no approved drug in the U.S. During the past 20 years or so, no new drugs have been introduced in the market for treatment of bladder cancer.

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum's expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and low-risk methods of commercialization. The company's pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease. For more information, please visit http://www.spectrumpharm.com.

Forward-looking Statements -- This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire and develop its portfolio of drug candidates, the Company's promising pipeline, the safety and efficacy of EOquin(R), side effects outside of the bladder, initiation of a Phase 3 study in the first half of this year, that EOquin(R) has the potential to make a difference in the lives of bladder cancer patients, that full data from the completed pilot study will be presented at a scientific conference in the coming months and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that past results may not be indicative of future results, the possibility that price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of significant revenues, our limited human and financial resources, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

Spectrum Pharmaceuticals

Genta Announces The Company Will Appeal FDA Action On New Drug Application Of Genasense(R) In Chronic Lymphocytic Leukemia

Genta Incorporated (Nasdaq: GNTA) today announced that the Company will appeal the non-approvable notice from the Food and Drug Administration's (FDA) Office of Oncology Drug Products of its New Drug Application (NDA) for the use of Genasense(R) (oblimersen sodium) Injection plus chemotherapy in patients with chronic lymphocytic leukemia (CLL). The appeal will be filed pursuant to the Formal Dispute Resolution process that exists within FDA's Center for Drug Evaluation and Research (CDER). The Company filed notice reserving its rights to appeal in December 2006 and expects to complete the filing of this appeal during the current calendar quarter.

Genasense in CLL

In the pivotal Phase 3 trial, patients with relapsed or refractory CLL were randomly assigned to receive fludarabine plus cyclophosphamide (Flu/Cy) chemotherapy with or without Genasense. This trial - the first randomized study ever conducted in this population - achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (CR/nPR) (17% vs. 7%; P=0.025). In addition, the duration of CR/nPR was significantly longer for patients treated with Genasense (median = not reached but will exceed 36+ mos. in the Genasense group vs. 22 mos. for patients treated with chemotherapy alone).

Prior to randomization on this trial, patients were prospectively stratified according to criteria that reflected their responsiveness to prior chemotherapy. The CR/nPR response to Flu/Cy alone was both equally poor (6-7%) and numerically inferior in all stratification groups. Clear trends, evident across all strata, suggested that the best response to Genasense occurred in patients who had received less extensive therapy. In addition to achieving the prospectively defined, intent-to-treat primary endpoint, patients in the Genasense group who were protocol-defined as "non-refractory" to fludarabine (comprising more than 40% of the total population) achieved:

-- A four-fold increase in CR/nPR (25% [13/51] vs. 6% [3/50]; P = 0.016)

-- Increased time-to-progression (median = 12 mos. vs. 10 mos.; P = N.S.)

-- Increased overall survival (median not reached but exceeding 39+ mos. vs. 33 mos.; P = 0.05)

About Genasense

Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.

About Genta

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company's research platform is anchored by two major programs that center on oligonucleotides (RNA- and DNA- based medicines) and small molecules. Genasense(R) (oblimersen sodium) Injection is the Company's lead compound from its oligonucleotide program. Genta has completed a pending Marketing Authorization Application to the European Medicines Agency (EMEA) for use of Genasense plus dacarbazine for treatment of patients with advanced melanoma. The leading drug in Genta's small molecule program is Ganite(R) (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: http://www.genta.com.

Safe Harbor

This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Forward- looking statements include, without limitation, statements about:

-- the Company's ability to obtain necessary regulatory approval for Genasense(R) from the U.S. Food and Drug Administration ("FDA") or European Medicines Agency ("EMEA");

-- the safety and efficacy of the Company's products or product candidates;

-- the Company's assessment of its clinical trials;

-- the commencement and completion of clinical trials;

-- the Company's ability to develop, manufacture, license and sell its products or product candidates;

-- the Company's ability to enter into and successfully execute license and collaborative agreements, if any;

-- the adequacy of the Company's capital resources and cash flow projections, and the Company's ability to obtain sufficient financing to maintain the Company's planned operations;

-- the adequacy of the Company's patents and proprietary rights;

-- the impact of litigation that has been brought against the Company and its officers and directors;

-- the Company's ability to regain compliance with the NASDAQ's listing qualifications; and

-- the other risks described under Certain Risks and Uncertainties Related to the Company's Business, as contained in the Company's Annual Report on Form 10-K and Quarterly Report on Form 10-Q.

The Company does not undertake to update any forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2005 and its most recent quarterly report on Form 10-Q.

Genta Incorporated

Texas Gov. Perry Signs Executive Order Mandating Girls Entering Sixth Grade Receive HPV Vaccine

Texas Gov. Rick Perry (R) on Friday signed an executive order mandating that girls entering the sixth grade receive a human papillomavirus vaccine beginning in September 2008, the Los Angeles Times reports (Bustillo, Los Angeles Times, 2/3). Merck's HPV vaccine Gardasil and GlaxoSmithKline's HPV vaccine Cervarix in clinical trials have 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 Gardasil 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. GSK in April plans to file for FDA approval of Cervarix, and it expects approval by the end of this year (Kaiser Daily Women's Health Policy Report, 2/1). The Texas mandate would affect approximately 365,000 girls annually, according to the Times. Perry on Friday in a statement said, "The HPV vaccine provides us with an incredible opportunity to effectively target and prevent cervical cancer," adding, "Requiring young girls to get vaccinated before they come into contact with HPV is responsible health and fiscal policy" (Los Angeles Times, 2/3). According to the New York Times, Perry said that parents who do not want their daughters to receive an HPV vaccine "for reasons of conscience, including religious beliefs," will be able to opt out of the requirement. Under the executive order, girls and women ages nine to 21 who are eligible for public assistance will be able to receive no-cost Gardasil beginning immediately, the New York Times reports. Perry did not say how much the mandate would cost the state, although it is estimated to be about $60 million. According to CDC spokesperson Curtis Allen, the vaccine is given in three shots over eight months and costs $360 (Blumenthal, New York Times, 2/3). Perry spokesperson Krista Moody said the state would increase funding for existing health programs by $29.4 million annually to help cover the cost of the vaccine for low-income women and girls (Los Angeles Times, 2/3). Perry in a statement said that Texas has the second-highest cervical cancer incidence in the nation (New York Times, 2/3). Last year, 1,169 new cervical cancer cases were reported and about 400 women in Texas died from the disease (Hoppe, Dallas Morning News, 2/3).

By issuing the executive order, Perry "sidestepp[ed]" the state Legislature and "avoided a showdown with GOP lawmakers and Christian organizations that oppose mandatory HPV vaccinations," the Los Angeles Times reports. Some conservative groups criticized Perry's mandate and said that Perry has received campaign contributions from Merck, the Los Angeles Times reports (Los Angeles Times, 2/3). "Follow the money," Cathie Adams, president of the Texas Eagle Forum, said, adding, "It leads to Merck." Merck in 2006 contributed $5,000 to Perry's campaign and has paid three lobbyists up to $250,000 this year, according to the Morning News. One lobbyist, Mike Toomey, formerly served as Perry's chief of staff. Perry's press secretary, Robert Black, said that the governor has not spoken to anyone from Merck or to Toomey about the executive order (Dallas Morning News, 2/3). Some public health advocates welcomed the executive order, according to the Los Angeles Times. "I'm surprised he took this step," Kathy Miller, president of the Texas Freedom Network, said, adding that "it breaks with his (political) base" (Los Angeles Times, 2/3).

Newspapers Examine Issues Surrounding HPV Vaccination
The Los Angeles Times on Monday examined whether HPV vaccination should be mandatory and who should decide whether women and girls receive the vaccine. According to the Times, the debate "highlights the balance between government's obligation to safeguard the health of its people and the rights of individuals to make their own decisions about matters affecting their health and their children's health" (Hendricks, Los Angeles Times, 2/5). In addition, the AP/Arizona Daily Star on Saturday examined how some physicians are not offering Gardasil because of "inadequate" reimbursements from insurers that do not cover administrative costs associated with the vaccine (AP/Arizona Daily Star, 2/3).

Two broadcast programs reported on the executive order:

  • NBC's "Nightly News": The segment includes comments from Maurie Markman, vice president for clinical research at the Gynecologic Oncology Center at M.D. Anderson Cancer Center; parents who oppose the vaccination requirement; and a girl who received the vaccine (Okwu, "Nightly News," NBC, 2/2). Video of the segment 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.

FISH-ing For Links Between Cancer And Aging

Wielding a palette of chromosome paints, scientists at the Salk Institute for Biological Studies have taken a step closer to understanding the relationship between aging and cancer by visualizing chromosomes of cells from patients with a heritable premature aging disease known as Werner Syndrome.

In a study to be published in this week's online edition of the Proceedings of the National Academy of Sciences researchers led by Jan Karlseder, Ph.D., assistant professor in Salk's Regulatory Biology Laboratory, showed that rebuilding structures called telomeres, which are found at the tips of each chromosome, significantly blocks the type of genetic damage seen in cells of patients with Werner Syndrome.

Patients with Werner Syndrome manifest signs of aging, such as skin wrinkling, baldness, or hair graying, in their teens. Most die in their 40's or 50's due to a predisposition to diseases like cancer. "Cancer is almost always related to chromosomal instability," explains Karlseder. "If telomeres are lost on individual chromosomes, then chromosomes are not protected and can fuse with other nonprotected chromosomes. Then when cells divide, chromosomes randomly break, leading to genome instability."

The current study extended work published in 2004 by Karlseder and first author Laure Crabbe, Ph.D., who was a graduate student in the Karlseder lab at the time. In that work, the team used a technique called FISH-short for fluorescent in situ hybridization-to microscopically visualize both the telomeres and chromosomal DNA from Werner Syndrome patients. They reported that some protective telomeres were actually missing on patients' chromosomes, a finding Karlseder describes as "a fairly catastrophic event for a cell."

For the current study, Salk researchers grew cells from Werner Syndrome patients in tissue culture dishes and, aided by colleagues at the Institute of Human Genetics in Heidelberg, Germany, evaluated DNA damage using a highly colorful variation of the FISH technique called chromosome painting. This technique "paints" or labels every pair of the 46 chromosomes with a different colored fluorescent dye, enabling investigators to easily see breakage or fusion of chromosomes that are characteristic of damaged DNA under the microscope.

Then they artificially supplied the cultured cells with one of two genes-either a functional copy of the WRN gene, which is mutant or nonfunctional in Werner Syndrome, or a gene encoding the protein telomerase, which elongates short or missing telomeres. After cells divided several times, their DNA was reexamined for the type of damage associated with both aging and cancer.

Cells supplied with a functional WRN gene showed decreased DNA damage compared to untreated cells, which was predictable: the WRN gene encodes a protein called a helicase that unwinds tightly coiled DNA strands when cells divide. Loss of WRN protein in individuals with Werner Syndrome is responsible for the disease. Explains Crabbe, now a postdoctoral fellow at The Institute of Human Genetics in Montpellier, France, "The lack of a single protein (WRN) induced loss of some telomeres, leading to a premature cellular growth arrest."

However, the most interesting finding was what the scientists observed in cells supplied with added telomerase. "When we put telomerase into cells, we suppressed accumulation of mutations to the same degree as when we put the WRN protein back," reports Karlseder. "It fixed the defect by elongating short telomeres seen in Werner Syndrome cells."

Crabbe, who is continuing to study DNA replication as a postdoc, concludes that these findings not only provide a mechanism underlying accelerated aging seen in Werner Syndrome but establish a link to cancer predisposition, saying, "These results indicate that the telomere dysfunction in Werner Syndrome cells is a major cause of genomic instability and could explain the high incidence of cancer seen in this disease."

Translating these findings into a treatment for Werner Syndrome will be extremely difficult. However, Karlseder feels optimistic about what these investigations show. "We study this disease because it is an excellent model for aging, and we show here a direct relation between aging, telomere loss, and cancer occurrence," he says. "I predict that cancer in older people has precisely the same basis as that seen in Werner Syndrome patients. That is why this was such a satisfying study."


Also contributing to this study were graduate student Colleen Naeger in the Karlseder lab and Anna Jauch, Ph.D., and Heidi Holgreve-Grez, Ph.D., in Heidelberg.

The Salk Institute for Biological Studies in La Jolla, California is an independent nonprofit organization dedicated to fundamental discoveries in the life sciences, the improvement of human health, and the training of future generations of researchers. Jonas Salk, M.D., whose polio vaccine all but eradicated the crippling disease poliomyelitis in 1955, opened the Institute in 1965 with a gift of land from the City of San Diego and the financial support of the March of Dimes.

Contact: Gina Kirchweger
Salk Institute

Sea Creature's Toxin Could Lead To Promising Cancer Treatment

A toxin derived from a reclusive sea creature resembling a translucent doughnut has inspired UT Southwestern Medical Center researchers to develop a related compound that shows promise as a cancer treatment.

In a study appearing online this week in the Proceedings of the National Academy of Sciences, the UT Southwestern scientists detail how the toxin blocks uninhibited reproduction of cultured human cancer cells while leaving healthy cells unaffected.

An accompanying study in PNAS shows that, in pre-clinical trials, a synthetic form of the toxin reduced human tumors implanted in mice without the harmful side effects seen using other cancer drugs. "Diazonamide is a special molecule - it's teaching us more than we imagined," said Dr. Patrick Harran, professor of biochemistry and a senior author on both studies.

"This is a truly exciting result," said Dr. John Schwab, a program officer at the National Insti tutes of Health's National Institute of General Medical Sciences, which partly funded the work. "Not only has this UT Southwestern team identified a potent anti-cancer drug, but its unique mode of action avoids the kinds of side effects that make cancer chemotherapy so difficult. It's a great example of how NIH support for fundamental chemical research can benefit the American health-care consumer."

The animal, Diazona angulata, is a sea squirt a few inches wide that lives in colonies anchored to rocks. It was discovered offshore of the Philippines in 1990 as scientists were looking for species that might lead to useful drugs. From a few specimens, scientists extracted a tiny amount of a toxin, diazonamide A, which the animal probably uses to repel predators.

The toxin proved to kill cancer cells in culture, but so little of its natural form was available that a race soon began to synthesize it in the laboratory.

A chemical structure for diazonamide A was published in 1991, but in 2001, Dr. Harran's group showed that initial report to be incorrect, and uncovered the correct structure. In the first of the two new studies, Dr. Harran and his co-workers synthesized several variants of diazonamide A in order to pin down how it prevents cancer cells from dividing.

Normal cell division involves a structure called the mitotic spindle, which pulls apart the chromosomes before the cell splits. The spindle is primarily made out of a substance called tubulin. Some anti-cancer drugs attack tubulin, but they have serious side effects, such as nerve damage and depletion of bone marrow and white blood cells.

The UT Southwestern researchers found that while diazonamide A blocked cell division, it seemed not to bind directly to tubulin. Instead, Dr. Xiaodong Wang, professor of biochemistry, and Dr. Gelin Wang, instructor of biochemistry, found that the toxin interacted with an enzyme called OAT, which was known to be involved in cellular metabolism but had no previously known role in cell division.

Interestingly, diazonamide did not block OAT's enzyme activity, the researchers said. Rather, it uncovered a second function for the protein in cell division.

"The finding that OAT is the cellular target of diazonamide is surprising for two reasons: First, there is no previous report that a mitochondrial enzyme like OAT can play a direct role in mitosis; second, OAT seems dispensable for normal cell division occurring in mice and men but is required for the division of cancer cells. This may explain the cancer specificity of diazonamide," said Dr. Wang, who is also a Howard Hughes Medical Institute investigator.

Dr. Noelle Williams, assistant professor of biochemistry and internal medicine, led the second phase of the research, which tested the effect of a variant of diazonamide A, called AB-5, in mice with tumors.

AB-5 has a structure nearly identical to diazonamide A and is indistinguishable in its biological action, but is easier to synthesize in the lab.

The researchers tested AB-5's effectiveness against cancer by implanting human tumor cells under the skin of m ice and treating them with either paclitaxel (Taxol) or vinblastine - both approved drugs currently used - or AB-5. The trial used tumor cells from human prostate, breast and colon cancers.

While all three drugs reduced tumors in the mice, the known drugs caused significant weight loss and loss of white blood cells while AB-5 caused neither side effect. "That the diazonamide toxin blocks mitosis selectively in cancer cells is almost too desirable an outcome to be true," said Dr. Steven McKnight, chairman of biochemistry and senior author of the second study. "As with any other unanticipated scientific discovery, the validity of these observations will be held to appropriately diligent scrutiny."


Other UT Southwestern researchers involved in the first study were graduate students Libin Shang and Anthony Burgett. That work was supported by the NIH and the Leukemia and Lymphoma Society.

Other UT Southwestern researchers involved in the second study were Mr. Burgett and Ashley Atkins, research assistant in biochemistry. That work was also supported by the NIH.

Joyant Pharmaceuticals, a Dallas-based company founded by Drs. Harran and Wang, has licensed the rights from UT Southwestern to develop diazonamide and its analogs as anti-cancer drugs. It is researching a manufacturing process and putting the molecule through pre-clinical screening.

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.

Dr. Patrick Harran

Dr. Noelle Williams

Contact: Aline McKenzie
UT Southwestern Medical Center

Painkiller Helps Against Child Cancer

Neuroblastoma is a form of cancer that develops in the nervous system and it affects small children more commonly than any other tumour type. Now, however, scientists at Karolinska Institutet in Sweden can show that a common painkiller can inhibit the development of neuroblastoma and help make treatment of the disease more effective.

The results apply to celecoxib, an analgesic, anti-inflammatory substance that works by inhibiting the effect of the inflammatory enzyme, Cox-2. In a study presented in Clinical Cancer Research, the research group has shown that celecoxib is also active against neuroblastoma, a type of tumour that depends on Cox-2 for its growth and proliferation.

The scientists have shown that celecoxib has an inhibitory and preventative effect on tumour development in rats. The substance also proved able to reinforce the effect of different cytostatics currently in use in the treatment of neuroblastoma.

"The painkiller can check the rapid division and growth of the cancer cells and block the blood vessels that supply the tumour with oxygen and nutrients," says John Inge Johnsen, researcher in child cancer at Karolinska Institutet.

The researchers conclude that celecoxib is a potential anti-neuroblastoma drug, possibly in combination with other drugs.

"But it's a matter of finding the right combination, as celecoxib can also counteract the tumouricidal effects of certain cytostatics," says Per Kogner, Professor at Karolinska Institutet and paediatrician at the Astrid Lindgren Children's Hospital in Stockholm.

The results from cell cultures and animals were obtained at concentrations that the scientists had previously measured in children receiving the medicine. They now plan to proceed to clinical trials, which will determine the way in which celecoxib can be used to treat neuroblastoma in children.

The research was conducted with the support of the Children's Cancer Foundation and the Swedish Cancer Society.

SE-171 77 Stockholm

Aida Pharmaceuticals' Researchers Publish Academic Article On Phase I Results Of Rh-Apo2L In Top Chinese Scholarly Journal

Aida Pharmaceuticals, Inc. (OTCBB: AIDA), one of Mainland China's leading pharmaceutical companies, today announced Company researchers have published an article entitled "Phase I Clinical Trial of Recombinant Human Apo-2 Ligand (Rh-Apo2L) in Patients with Advanced Cancer," in one of Mainland China's leading scholarly journals, Chinese Journal of New Drugs.

The article was written by Zhou Sheng-Yu, Chen Shan-Shan, Liu Peng, Luo Yang, Xing Pu-Yuan, He Jing, Liu Xiao, Li Duan and Feng Feng-Yi, scientists and medical professionals from the Department of Medical Oncology of the Cancer Hospital at the Chinese Academy of Medical Sciences and the Peking Union Medical College in Beijing's Laboratory of Pharmacy at the College of Pharmacy of Fudan University in Shanghai. These institutions were major participants in the Phase I clinical trial of Rh-Apo2L. The article is an overview of the Phase I clinical trial methodology and results.

Chairman of Aida Pharmaceuticals, Mr. Jin Biao, stated, "The inclusion of Aida Pharmaceuticals' research in the Chinese Journal of New Drugs is testament to academia's acceptance of the Phase I study of Rh-Apo2L. Rh-Apo2L was approved to begin Phase II trials by the State Food and Drug Administration of China at the end of last year, which makes Aida the first and only pharmaceuticals company in the world to receive approval for further clinical research of this kind of anticancer drug. We believe that Rh-Apo2L may be a revolutionary drug for the treatment of cancer and a catalyst for explosive growth for the Company."

About the Chinese Journal of New Drugs:

The Chinese Journal of New Drugs was founded in January of 1992, this monthly journal is a nationally distributed publication recognized by the pharmaceutical industry in China. It is administered by the State Food and Drug Administration (SFDA) and sponsored by several organizations including Chinese Pharmaceutical Association.

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.

Texas Gov. Perry Asked To Rescind Executive Order Mandating HPV Vaccination For Girls Entering Sixth Grade

A group of Texas lawmakers on Monday asked Gov. Rick Perry (R) to rescind an executive order that would mandate vaccination against human papillomavirus for girls entering the sixth grade, the Houston Chronicle reports (Elliott, Houston Chronicle, 2/6). Perry on Friday signed the executive order, which will affect approximately 365,000 girls annually. Perry said that parents who do not want their daughters to receive an HPV vaccine "for reasons of conscience, including religious beliefs," will be able to opt out of the requirement. Under the executive order, girls and women ages nine to 21 who are eligible for public assistance will be able to receive Merck's HPV vaccine Gardasil at no cost beginning immediately. Perry did not say how much the mandate would cost the state, although it is estimated to be about $60 million. Perry spokesperson Krista Moody said the state would increase funding for existing health programs by $29.4 million annually to help cover the cost of the vaccine for low-income women and girls. Gardasil and GlaxoSmithKline's HPV vaccine Cervarix in clinical trials have 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 Gardasil 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. GSK in April plans to file for FDA approval of Cervarix, and it expects approval by the end of this year (Kaiser Daily Women's Health Policy Report, 2/5).

State Sen. Jane Nelson (R) on Monday asked Perry to reverse the order and said she would ask Texas Attorney General Greg Abbott (R) about the mandate's legality and whether the Legislature has any recourse (Houston Chronicle, 2/6). Nelson also said that the Legislature should hear testimony from doctors, scientists and patients before mandating the vaccine. "This is not an emergency," Nelson said, adding, "It needs to be discussed and debated" (Dallas Morning News, 2/5). Sen. Glenn Hegar (R) said he would introduce a bill to reverse the mandate (Houston Chronicle, 2/6). Reps. Dennis Bonnen (R) and Charlie Howard (R) filed a bill (HB 1098) that would prohibit requiring students to receive an HPV vaccination to attend public schools (Dallas Morning News, 2/5). Critics said mandating the vaccine would send a message to girls that sex is permissible. Perry in a statement said the vaccine does not "promote sexual promiscuity any more than providing the hepatitis B vaccine promotes drug use," adding, "If the medical community developed a vaccine for lung cancer, would the same critics oppose it claiming it would encourage smoking?" Other opponents of the mandate said that Perry issued the order in return for campaign contributions from Merck (Houston Chronicle, 2/6). Merck in 2006 contributed $5,000 to Perry's campaign and has paid three lobbyists up to $250,000 this year. One lobbyist, Mike Toomey, formerly served as Perry's chief of staff. Perry's press secretary, Robert Black, said that the governor has not spoken to anyone from Merck or to Toomey about the executive order (Kaiser Daily Women's Health Policy Report, 2/5). Black said, "The governor is very pro-life, and he views [HPV vaccination] as protecting life," adding, "Not to pursue that opportunity, the governor believes that would be morally reprehensible" (Houston Chronicle, 2/6).

Related Editorials, Opinion Piece
Several newspapers have published editorials and opinion pieces in response to the executive order. Summaries appear below.


  • Austin American-Statesman: Perry' executive order was a "bold move ... on an issue where Texas usually lags -- health care," an American-Statesman editorial says. However, Perry's mandate "carries political, as well as medical, social and religious baggage," with his connection to Merck, the editorial says. It "could turn out that Perry's executive order is the perfect marriage of profit and health care," but no matter the outcome, "parents should have their girls vaccinated to guard against cervical cancer. And the government should make those vaccinations available to families who are uninsured or can't afford it," the American-Statesman concludes (Austin American-Statesman, 2/6).

  • New York Times: "Other states would be wise to follow" Texas in requiring HPV vaccines, a Times editorial says. Some people fear that HPV vaccination might encourage teenagers "to engage in risky behavior" and some "complain that there are already a slew of required vaccinations," the editorial says, adding that none "of these objections seem strong enough to forgo the protection against a devastating disease." The editorial concludes, "All students deserve protection against HPV infection, and the presumption should be that they will get it" (New York Times, 2/6).

Opinion Piece
  • Rep. Eddie Johnson (D-Texas), Austin American-Statesman: "Though parents can opt out of the vaccination requirement on religious or philosophical grounds, I would hope they would want to spare their daughters such trauma and stigma" of cervical cancer, Johnson writes in an American-Statesman opinion piece. "What strides could we make if we embraced the concept of prevention, regardless of our feelings on premarital sex?" Johnson asks, adding that "providing the vaccine does no harm and can potentially do plenty of good" and that it might be "unethical to not ... use a scientific development to eliminate a disease." Johnson writes that the mandate is a "pro-woman policy," concluding that Texas parents "should join with state officials to make this vaccine as affordable and accessible as the other vaccines that have revolutionized our public health system" (Johnson, Austin American-Statesman, 2/6).

NPR's "All Things Considered" reported on states that are considering vaccine mandates and Merck's efforts to market Gardasil. The segment includes comments from David Catania, a member of the Washington, D.C, City Council; Richard Haupt, a medical director at Merck; and Neal Halsey, a pediatrician and vaccine expert in the Department of International Health at the Bloomberg School of Public Health at Johns Hopkins University (Wilson, "All Things Considered," NPR, 2/6). Audio of the segment is available online. In addition, "All Things Considered" included an interview with the mother of a 3-year-old girl about whether she would vaccinate her daughter against HPV (Norris, "All Things Considered," NPR, 2/6). Audio of the segment 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.