Multi-Pronged Therapeutic Cancer Vaccine Regimen to be Studied in Melanoma Patients

Multi-Pronged Therapeutic Cancer Vaccine Regimen to be Studied in Melanoma Patients

PARIS, and TORONTO, Sept 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 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 .
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: www.sanofipasteur.com [1].

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