Navigation Links
Multi-Pronged Therapeutic Cancer Vaccine Regimen to be Studied in Melanoma Patients
Date:9/17/2008

PARIS, and TORONTO, Sept. 17 /PRNewswire/ -- Sanofi pasteur, the vaccines division of the sanofi-aventis Group, announced today that it is sponsoring a Phase II clinical study exploring a multi-pronged treatment approach to high risk and advanced-stage melanoma -- an often fatal form of cancer for which there are limited treatment options. Patients are being enrolled in the United States and Canada. The trial, called MEL11, will investigate the safety and efficacy of a therapeutic cancer vaccine regimen aimed at stimulating the body's immune system to fight melanoma.

"The MEL11 study uses an entirely new treatment approach to advanced-stage melanoma," said Teresa Petrella, MD, Medical Oncologist and Clinical Researcher at the Odette Cancer Centre at the Sunnybrook Health Sciences Centre in Toronto and the lead investigator of the trial. "The study protocol combines the use of a vaccine with more traditional anti-cancer agents to bolster the effectiveness of the immune system. Melanoma is an increasing concern in the cancer community; its incidence is on the rise and there are very few available treatment options."

The vaccine candidate is uniquely designed to stimulate the body's own defenses -- the immune system -- to find and fight cancer cells. It makes use of a modified canarypox virus, ALVAC(2), which has been shown in an extensive body of research to promote immune responses in humans. The ALVAC(2) virus contains the genes for five antigens -- molecules that induce an immune response -- that are commonly found in melanoma tumors. These antigens stimulate T-cells within the immune system to hone in on melanoma cells, and are expected to halt or slow cancer progression. The vaccine also contains the genes for three proteins called co-stimulatory molecules, which increase the immune response of T-cells to the antigens. In addition to the vaccine, patients in this trial will be treated with two other agents that augment the immune response: GM-CSF and interferon-alpha-2b.

About the Clinical Trial

The randomized, open-label trial involves 120 participants at 23 centers across the United States and Canada. Stage IIIc, IVa and IVb melanoma patients with at least one measurable lesion and a life expectancy of at least six months will be included in the study. Participants will be randomized to one of two study groups. The first group will receive vaccine treatment consisting of a series of ALVAC and GM-CSF injections, followed by administration of interferon. The second group will receive administration of interferon alone.

The study is designed with the primary objective of progression-free survival (tumor stabilization) and the secondary objective of evaluation of safety, other efficacy endpoints (response rates), and the ability of the treatment regimen to induce an immune response.

The first cycle of vaccine treatment is conducted for a period of 16-weeks. If there is no evidence of disease progression during the first cycle, vaccine treatment is extended to a second 16 week cycle of treatment. In the study, patients in Group 2 whose disease has progressed during the first treatment cycle may be offered the vaccine regimen as the next cycle of treatment.

About Melanoma

Melanoma is the most serious form of skin cancer, accounting for 80 percent of all skin cancer deaths. Incidence and mortality rates for melanoma are rising faster than those for any other cancer. According to the American Cancer Society and Canadian Cancer Society, this year nearly 65,000 people in North America will be diagnosed with melanoma and more than 9,000 will die from the disease. By the year 2010, it is estimated that one in 50 people will have been diagnosed with melanoma. Standard treatments have minimal effect on survival, and sometimes cause significant toxicity.

About Therapeutic Cancer Vaccines

Therapeutic cancer vaccines represent an emerging, experimental type of immunotherapy, which are being used in combination with standard cancer treatments. They are different from preventive or prophylactic vaccines, which are used to prevent initial infection and disease. Researchers believe therapeutic cancer vaccines may help inhibit the progression of existing cancers, prevent recurrence of cancers, or destroy remaining cancer cells not killed by prior treatments.

For more information on this program visit http://www.cancervaccines.com.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi pasteur, the vaccines division of sanofi-aventis Group, provided more than 1.6 billion doses of vaccine in 2007, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, sanofi pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR1 million in research and development. For more information, please visit: http://www.sanofipasteur.com.

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2007. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

Global Media Relations U.S. Media Relations

Pascal Barollier Len Lavenda

T. +33-(0)4-37-37-50-38 T. +1-570-839-4446

Pascal.barollier@sanofipasteur.com len.lavenda@sanofipasteur.com

http://www.sanofipasteur.com http://www.sanofipasteur.us
Canadian Media Relations

Nancy Simpson

T. +1-416-667-2955

nancy.simpson@sanofipasteur.com

http://www.sanofipasteur.ca


'/>"/>
SOURCE sanofi pasteur
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
2. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
3. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
4. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
5. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
6. Pharmacopeia Assists the World Health Organization in the Discovery of Novel Therapeutics for the Treatment of Malaria
7. Protalix BioTherapeutics Treats First Patient in Phase III Clinical Trial of prGCD
8. TorreyPines Therapeutics Initiates a Phase I Multiple Dose Clinical Trial of Tezampanel
9. Zila Inc. Product Selected to Identify Pre-Cancer in Study of Leading Cancer Treatment Chemotherapeutic - ERBITUX
10. Advanced Life Sciences to Present Data on Selected Cethromycin Therapeutic Studies at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy
11. TorreyPines Therapeutics Completes Phase I Multiple Dose Clinical Trial of NGX267, a Selective M1 Agonist for the Potential Treatment of Cognitive Impairment Associated with Schizophrenia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/9/2016)... SAN DIEGO , Feb. 9, 2016 ... developing novel, clinical-stage therapies for sickle cell disease and heart ... common stock and warrants to purchase common stock in an ... other conditions, and there can be no assurance as to ... to the actual size or terms of the offering.   ...
(Date:2/9/2016)... LONDON , Feb. 9, 2016 Hearing ... amount of sound energy transmitted to the inner ear. ... and hearing bands. These devices are recommended for users ... eight hours. Earplugs refer to HPD that are inserted ... attenuation earplugs are designed to provide more natural sound ...
(Date:2/9/2016)... LONDON , Feb. 9, 2016 This ... surgical interventions, reported by the ICD-9 coding system in ... to the surgical procedure volumes, the report provides written ... and dynamics of the local markets. In addition, the latest ... --> --> The ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... 08, 2016 , ... Brenton Engineering , powered by ... flow wrapped products at WestPack 2015, February 9-11, in Anaheim, California. This new ... semi-automatic or fully-automatic case packing with a small footprint, rugged, highly flexible, and ...
(Date:2/8/2016)... ... February 08, 2016 , ... Tingley Rubber ... Canada to provide its range of unique and advantaged protective solutions to ... that will provide bilingual customer service and marketing support. A new distribution center ...
(Date:2/8/2016)... ... February 08, 2016 , ... The Bell Agency, a ... latest beneficiary of their ongoing community enrichment program. The current campaign fundraises for ... Donations are now being accepted at: http://www.angelsanddoves.com/donate.html . , Angels & Doves ...
(Date:2/8/2016)... San Francisco, CA (PRWEB) , ... February 08, 2016 , ... ... helped raise $792,000 to help combat pancreatic cancer. , Gary D. Radine, who recently ... who also was the American Cancer Society’s 2015 CEO of the Year , ...
(Date:2/8/2016)... ... , ... Remember the old saying “rub some dirt on it”? Perhaps you ... “Calcium Bentonite Clay” the health benefits of integrating clay into a daily diet are ... A former motivational speaker, Perry A~ has since dedicated her life to learning about ...
Breaking Medicine News(10 mins):