To: nigel bates who wrote (288 ) 9/26/2000 12:28:34 PM From: nigel bates Read Replies (1) | Respond to of 438 Sept. 26 /PRNewswire/ -- Genzyme Molecular Oncology (Nasdaq: GZMO - news) announced today that it has initiated a phase 1-2 clinical trial to assess the safety, immunogenic efficacy, and potency of a gene therapy cancer vaccine for melanoma, the most serious type of skin cancer. This in vivo gene therapy vaccine combines two of the most widely expressed melanoma tumor antigens, MelanA/MART1 and gp100. The vaccine will employ an adenovirus vector to deliver the antigens intradermally, or between the layers of the skin. Cancer vaccines are designed to stimulate the body's immune system to seek out and destroy cancer cells that display the same antigen included in the vaccine. Antigens are proteins that are present in cancer cells and prompt an immune response to those cells. Frank G. Haluska, M.D., Ph.D., at the Massachusetts General Hospital Cancer Center, is the lead investigator for the trial. Trial sites include Massachusetts General Hospital in Boston and U.S. Oncology in Dallas, TX. Approximately 36 patients with Stage 2, 3, or 4 melanoma who have been completely surgically resected will be enrolled in the study. People suffering from these stages of melanoma are encouraged to call and inquire about entry requirements for the trial at 617-724-7081 in Boston, or 214-370-1822 in Dallas. Genzyme Molecular Oncology is currently conducting a phase 1-2 ex vivo gene therapy melanoma vaccine clinical trial at Massachusetts General Hospital under Dr. Haluska. The trial is enrolling Stage 3 and Stage 4 melanoma patients with active disease. The ex vivo trial takes cells from the patient's immune system and insures that those cells contain the vaccine before re-introducing them to the patient's body. The new in vivo trial will take the next step toward commercialization by delivering the vaccine directly to the patient. It will rely on Genzyme Molecular Oncology's gene delivery technology to deliver the vaccine to the appropriate cells in the immune system. ``We have designed the in vivo melanoma trial to help skin cancer patients mount a strong immune system response to their tumor, and to enable us to obtain gene delivery data that will help us develop cancer vaccines for a range of cancers,'' said Mark Goldberg, M.D., senior vice president medical affairs, oncology, Genzyme. ``This trial bolsters our clinical program, which will continue to expand as we initiate four additional vaccine clinical trials-two in melanoma and two in kidney cancer-using our fusion cell therapy technology. We are also utilizing our powerful antigen discovery technologies to identify tumor-specific antigens that may be used in vaccines for additional major indications, such as prostate, breast, and lung cancers.'' Genzyme Molecular Oncology has completed two phase 1 cancer vaccine trials in melanoma. These studies demonstrated that treatment with either the MelanA/Mart1 or the gp100 antigen was safe and well-tolerated. Genzyme Molecular Oncology has optimized data from these two trials in designing its in vivo phase 1-2 melanoma trial. This leading-edge study will combine two tumor antigens, which is expected to increase the potency of the vaccine in eliciting an immune response. Also, because the vaccine is gene-based, it is expected to prolong presentation of antigens to T cells, allowing the T cells to make a more powerful attack against the tumor cells. Additionally, the immune response may also be sustained for a longer period of time because the vaccine contains the entire genes for each tumor antigen, which may enhance the expected immune response....