Gonorrhoea Linked To Bladder Cancer In Men

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

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

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

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

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

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

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

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

Bladder cancer

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

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

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

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

British Journal of Cancer (BJC)

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

About Cancer Research UK

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

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

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

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

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

http://www.cancerresearchuk.org

Lung Cancer Vaccine Enters Large-scale Clinical Trial

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

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

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

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

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

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

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

Lung cancer

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

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

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

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

START trial

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

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

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

Cancer Research Technology

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

About Cancer Research UK

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

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

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

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

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

http://www.cancerresearchuk.org

Call For Better Prostate Cancer Biopsies

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The NHS Prostate Cancer Risk Management programme

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

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

About Cancer Research UK

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

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

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

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

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

http://www.cancerresearchuk.org

Launch Of Queens Library Healthlink Initiative

WHO:

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

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

Entertainers: Jazz Band of Renaissance Charter School, Jackson Heights

WHAT: Launch of Queens Library HealthLink Initiative

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

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

***

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

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

The Queens Library HealthLink will:

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

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

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

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

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

###

Contact: Christine Hickey
Memorial Sloan-Kettering Cancer Center

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

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

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

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

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

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

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

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

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

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

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

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

About Mundipharma

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

About BioCryst

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

Forward-looking statements

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

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

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

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

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

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

About Cachexia and VT-122

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

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

About Vicus Therapeutics

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

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

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

CEL-SCI Corporation (Amex: CVM), (Germany: LSR) today announced that the U.S. Food and Drug Administration (FDA) has stated in a letter to the Company that, "...the proposed Phase III study may proceed at any time." CEL-SCI's Phase III clinical study is designed to prove that its cancer drug Multikine(R) increases the survival of head and neck cancer patients.

The study is expected to be conducted in numerous countries around the world. It is designed to develop conclusive evidence of the efficacy of the Multikine treatment regimen in advanced primary squamous cell carcinoma of the oral cavity (head and neck cancer). Upon successful completion of this study, the data will be included in CEL-SCI's worldwide Marketing Applications to make Multikine commercially available for the treatment of this patient population. Head and neck cancer is an aggressive disease affecting about 500,000 people per annum worldwide.

Geert Kersten, Chief Executive Officer of CEL-SCI, said, "So far Multikine has been shown to be non-toxic, which is very unusual for a cancer drug. In Phase II clinical studies with head and neck cancer patients it also markedly increased survival. Now we will get the chance to prove that Multikine can extend the survival of these cancer patients."

The global Phase III study will test the hypothesis that the Multikine treatment regimen, administered locally prior to the current standard therapy given to patients with advanced primary squamous cell carcinoma of the oral cavity, will extend the overall survival and enhance the local/regional control of the disease, while increasing disease free survival in these patients.

Multikine is a patented immunotherapeutic agent consisting of a defined mixture of naturally occurring cytokines, including interleukins, interferons, chemokines and colony-stimulating factors.

CEL-SCI Corporation is developing new immune system based treatments for cancer and infectious diseases. The Company has operations in Vienna, Virginia and Baltimore, Maryland.

When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties, which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital, inability to get American Stock exchange approval for any transaction and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10- K for the year ended September 30, 2005. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date thereof or to reflect the occurrence of unanticipated events.

CEL-SCI Corporation
http://www.cel-sci.com

Update On Craniofacial Cancers

The November/December issue of The Journal of Craniofacial Surgery presents a Special Section devoted to cancers of the head, face, and skull. Highlights include a review of giant congenital nevi, a relatively frequent problem that can pose a difficult challenge for surgeons; reports on a number of rare craniofacial cancers, including some unique challenges facing surgeons in non-Western countries; and some innovative treatment and reconstructive approaches.

Congenital nevi are birthmarks or moles that are present at birth small to medium-sized nevi are common and usually do not need surgery. However, a small percentage of infants have very large, or "giant" congenital nevi. These giant nevi have a high rate of transformation into malignant melanoma, an aggressive type of skin cancer.

Surgery to remove giant nevi avoids the risk of melanoma. However, the location and large size of the nevi make surgery highly challenging. The lead article in the special section highlights some of the other diseases and malformations that can be associated with giant nevi, as well as the along with the options for surgical treatment. Another article reports on the rapid development of a rare but very serious complication of giant congenital nevus, called neurocutaneous melanosis.

Other papers draw attention to rare or unusual cancers of the face, head, and neck. A study from Turkey reports on the evaluation and treatment of very large or extensive facial tumors some developing in patients who received no medical attention for many years. Although surgical reconstruction can achieve reasonably good results in such cases, "complex and long-lasting" operations should be reserved for younger patients, the authors believe. A group of Iranian surgeons describe the characteristics of cancers of the mouth in that country. They underscore the urgent need for efforts to improve early detection of oral cancers in Iran, since cancers diagnosed at an advanced stage are usually incurable.

Other studies report on rare conditions including nevus sebaceous of Jadassohn, a congenital lesion that is best recognized and removed early in life because of later cancer risk; and some rare complications of xeroderma pigmentosum, a condition that makes the skin highly sensitive to the damaging effects of ultraviolet radiation in sunlight.

The special section concludes with three reports on new scientific advances and techniques, including a study of the genetic effects of Medpor an artificial material used for bone reconstruction on bone-forming cells. Another study describes a new, gentler surgical approach to the difficult problem of removing tumors from the eye socket. The final paper reports on a new technique for preserving the colored part of the lip, or "vermilion border," for patients requiring surgery for tumors in that area.

"We hope the publication of this special section will help draw attention to some of the recent innovations and advances in the treatment of craniofacial cancers and encourage further work in this important area," comments Dr. Mutaz B. Habal, Editor-in-Chief of JCS.

About The Journal of Craniofacial Surgery

The Journal of Craniofacial Surgery serves as a forum of communication for all those involved in craniofacial and maxillofacial surgery. Coverage ranges from practical aspects of craniofacial surgery to the basic science that underlies surgical practice. Founded and edited by Mutaz B. Habal, MD, of Tampa, FL, the Journal is affiliated with major specialty societies worldwide, including the American Association of Pediatric Plastic Surgeons, the American Academy of Pediatrics Section of Pediatric Plastic Surgery, the American Society of Craniofacial Surgeons, the European Society of Craniofacial Surgery, the International Society of Craniofacial Surgery, the Japanese Society of Craniofacial Surgery, the Korean Society of Craniofacial Surgery, the Argentine Society of Plastic Surgery Section of Pediatric Plastic Surgery, the American Society of Maxillofacial Surgeons, the World Craniofacial Foundation, and the Brazilian Society of Craniomaxillofacial Surgery. Visit the journal website at http://www.jcraniofacialsurgery.com.

About Lippincott Williams & Wilkins

Lippincott Williams & Wilkins (http://www.LWW.com) is a leading international publisher for physicians, nurses, specialized clinicians, and students. Nearly 275 periodicals and 1,500 books in more than 100 disciplines are published under the LWW brand, as well as content-based sites and online corporate and customer services. LWW is part of Wolters Kluwer Health, a leading provider of information for professionals and students in medicine, nursing, allied health, pharmacy, and the pharmaceutical industry. Wolters Kluwer Health is a division of Wolters Kluwer, a leading multinational publisher and information services company with annual sales of €3.4 billion (2005) and approximately 18,400 employees worldwide.

Lippincott Williams & Wilkins
530 Walnut St.
Philadelphia, PA 19106
United States
http://www.lww.com

Transgenomic Inc. Launches Next Generation SURVEYOR(R) Mutation Detection Kits For Fluorescent Capillary Electrophoresis

Transgenomic, Inc. (Nasdaq: TBIO) announced today that it is launching its next generation SURVEYOR Mutation Detection Kits for universal primer fluorescent capillary electrophoresis. The kits detect mismatch mutations in DNA that has been PCR amplified using two fluorescent primers and digested with SURVEYOR Nuclease. This then allows highly sensitive mutation detection on Applied Biosystems DNA sequencing instruments. It will be a key tool for scientists needing high-throughput analysis of genetic variation, even for those variations present at very low levels such as somatic mutations linked to cancer and its treatment.

Introduced by Transgenomic in 2004, SURVEYOR Nuclease is a proprietary mismatch-specific endonuclease that efficiently detects any mismatches in double-stranded DNA and cleaves at the site of DNA mutations. It identifies all base substitutions, insertions and deletions and can detect multiple mutations in a single fragment, in individual or even pooled PCR samples. SURVEYOR Nuclease's effectiveness in disease specific mutation discovery has been well documented in many peer-reviewed publications over the past two years.

In announcing the product launch, Craig Tuttle, Transgenomic, Inc. CEO, commented that, "We are excited to extend the SURVEYOR Mutation Detection Kit product line and provide such an important research tool to detect mutations that sequencing cannot find, or finds difficult to reveal. SURVEYOR also saves researchers time and money with its increased precision. SURVEYOR Endonuclease is an important expansion of Transgenomic's mutation detection product portfolio which is exemplified by our WAVE(R) System platforms and our emerging CLIA and GLP Clinical Reference Laboratory and Genomic Analysis and Research Services."

To find out more about SURVEYOR Nuclease, go to http://www.transgenomic.com

About Transgenomic: A decade of discovery 1997 - 2007

Transgenomic is a global biotechnology company that provides unique systems, products, discovery and laboratory testing services to the academic and medical research, clinical and pharmaceutical markets for automated high sensitivity genetic variation and mutation analysis in the fields of pharmacogenomics and personalized medicine. This is accomplished through their offerings of Wave(TM) DHPLC systems, reagents, consumables and assay kits, automated cytogenetics systems and Transgenomic Discovery and CLIA Lab Services. To date there have been over 1,200 Wave systems installed in over 600 customer sites in over 35 countries and approximately 1,500 publications utilizing Transgenomic products or services. Transgenomic Discovery and Lab Services utilize their technology and expertise to provide a menu of mutation scanning tests for over 700 cancer-associated genes and more than 60 validated diagnostic tests to meet the needs of pharmaceutical and biotech companies, research and clinical laboratories, physicians and patients. For more information about the innovative systems, products and services offered by Transgenomic, please visit: http://www.transgenomic.com.

Transgenomic Cautionary Statements

Certain statements in this press release constitute "forward-looking statements" of Transgenomic within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to management's current views and estimates of future economic circumstances, industry conditions, company performance and financial results, including the ability of the Company to grow its involvement in the diagnostic products and services markets. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in Transgenomic's reports to the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

Transgenomic, Inc.
http://www.transgenomic.com