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| | | ![]() CRADA Signed to Develop Treatment for Severe Skin Cancer CAMBRIDGE, Mass., Oct. 15, 1996 -- Genzyme Corp.'s General Division (Nasdaq: GENZ) today announced it has entered into a three-year Collaborative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to develop a treatment for metastatic melanoma, an inoperable form of skin cancer. The CRADA covers the use of Genzyme adenoviral vectors that incorporate the genes for proprietary melanoma tumor antigens, MART-1 and gp100, developed by Steven A. Rosenberg, M.D., Ph.D., chief of surgery at NCI. These antigens are expressed at high levels on melanoma tumors. The researchers hope that, by injecting patients with the genes, the expressed antigens will stimulate the patient's immune system to attack the tumor cells. Under the terms of the CRADA, Genzyme will provide Dr. Rosenberg with clinical-grade adenoviral vectors as well as research and development funding to support clinical trials at NCI. If these adenoviral vectors are successful, Genzyme intends to exercise its option for exclusively marketing these vectors. Genzyme has worked with Dr. Rosenberg for the last 18 months and provided clinical-grade vectors in support of two phase I studies. More than 40 patients have been treated in the two phase I trials now in progress. Results from these trials should be available in early 1997. Melanoma is the fastest-growing type of cancer, with 38,000 new cases last year. Metastatic melanoma is a fatal skin cancer that kills about 8,000 people per year. There is no effective treatment available for metastatic melanoma. In commenting on the agreement, Gail Maderis, Genzyme's vice president for gene therapy, stated, "Cancer is one of the leading targets of gene therapy research worldwide. The approach taken by Dr. Rosenberg of stimulating the patient's immune system through the use of melanoma-specific tumor antigens represents a very promising technique for combating metastatic disease. Collaborating with Dr. Rosenberg and the NCI presents an exciting opportunity for Genzyme, and enhances our position as a broad-based gene therapy company." Genzyme has developed viral and lipid-based vector systems to support the commercialization of gene therapies. The company is focusing on applications for genetic disease, cancer, cardiovascular disease, and infectious disease. With fully integrated capabilities, Genzyme has participated in eight clinical trials in gene therapy to date at eight clinical sites in the U.S. and Europe, and established productive collaborations with leading academic groups. One of the world's top five biotechnology companies, Genzyme focuses on developing innovative products and services for major unmet medical needs. The company's General Division develops and markets pharmaceuticals, genetic diagnostic services, and diagnostic, surgical, and specialty therapeutic products.
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