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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
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