Friday, Apr 5, 1991
South San Francisco, Calif. -- April 5, 1991 --Genentech, Inc. this week began human clinical trials at the UCLA School of Medicine of a monoclonal antibody that may be useful in the management of breast and ovarian cancers.
This project is the first to apply Genentech's expertise in producing drugs through recombinant protein manufacturing to the development of monoclonal antibodies, and is one of the first efforts to treat cancer by targeting a specific oncogene product.
With an estimated 150,000 new cases each year, breast cancer is the most common form of cancer among women, and, despite current therapies, is second only to lung cancer as a cause of death. Ovarian cancer is the fifth most common cancer among women -- with more than 20,000 new cases reported last year -- and is fatal in 62 percent of the cases. Together, these two account for one third of all malignancies and one quarter of all cancer related deaths in women.
Abnormally increased numbers of a gene in the tumor cell, called the HER-2 oncogene, are present in about one-third of all breast and ovarian cancer cases. The increased amounts of this oncogene set off a chain reaction which supports the growth of the HER-2 overexpressing tumor cell. More specifically, the increase in HER-2 oncogenes results in increased production of a cell surface receptor molecule, which promotes tumor growth.
Genentech researchers have developed a monoclonal antibody, against the HER-2 protein, which, in laboratory studies, specifically blocks the surface molecules, inhibits growth of tumor cells in culture, and increases the tumor's susceptibility to the body's immune system.
Phase I human clinical trials are being conducted by Dennis Slamon, M.D., Ph.D., associate professor of medicine in the division of hematology and oncology at UCLA and director of the Revlon/UCLA Women's Cancer Research Program. Dr. Slamon collaborated with Axel Ullrich of Genentech on the discovery of the link between the overabundance of the HER-2 oncogene and aggressive human cancer which contributed to the development of this antibody.
The trials will involve 20 breast and ovarian cancer patients who are characterized as expressing high levels of the HER-2 receptor, and who have not responded to available therapies. The drug's safety and dosing profiles will be evaluated.
Michael Shepard, Ph.D., Genentech senior scientist on the project said, "It isn't often that a cancer-promoting menace makes itself amenable to attack from the outside." He added, "The preclinical data are very strong. We're hopeful that the human therapeutic effect of the HER-2 antibody's interference in tumor growth will be confirmed."
Genentech, Inc., is a leading biotechnology company focusing on the development, manufacture and marketing of pharmaceuticals produced by recombinant DNA technology.
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