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Thirty-three-year-old engineering technician Christopher Lamb was diagnosed with non-Hodgkin's B-cell lymphoma in January, 1997. Christopher is currently receiving therapy through an ongoing Phase II clinical trial that is testing the effectiveness of the C2B8 antibody combined with standard chemotherapy. Genentech and its partners IDEC Pharmaceuticals and Roche have filed for worldwide regulatory clearance to market the C2B8 antibody as a stand-alone therapy for relapsed low-grade non-Hodgkin's B-cell lymphoma based on earlier clinical studies.

According to Susan D. Hellmann, M.D., M.P.H., an oncologist by training and Genentech's vice president of Medical Affairs and chief medical officer, "In the area of oncology, our objective is very straightforward: to improve cancer therapy by both increasing survival time and improving quality of life."

The pipeline product closest to meeting that potential is the C2B8 antibody, which was identified by Genentech's partner IDEC Pharmaceuticals and which has been submitted for regulatory clearance for marketing as a treatment for relapsed low-grade non-Hodgkin's B-cell lymphoma. Genentech and IDEC are working closely with the U.S. Food and Drug Administration on the regulatory review and inspection process in an effort to achieve an expeditious clearance for marketing.

The C2B8 antibody exemplifies the approach taken by all of the oncology products in Genentech's pipeline: "Our strategy is first to understand the underlying disease mechanism of cancer," said Hellmann, "and second, to try to target, using therapeutic antibodies, the tumor-specific markers or disease processes such that we inhibit or delay tumor growth."

Therapeutic antibodies are ideally suited for the task. These highly targeted molecules are made naturally in a mouse immune system and "humanized" to reduce allergic response in humans. Because of their specificity and their human protein structure, they have the potential to deliver their therapeutic effects without the serious side effects typical of traditional chemotherapeutic approaches.

The other therapeutic antibodies targeting cancer in Genentech's pipeline also represent significant firsts. The anti-HER2 antibody for breast cancer, currently in Phase III clinical trials, targets tumors that have excessive copies of a specific protein, the HER2 receptor molecule. About a third of all breast cancer patients have tumors with an excess of this specific receptor, and these typically represent the breast cancer patients with the worst prognosis. The HER2 antibody represents Genentech's first therapeutic antibody targeting a solid tumor cancer.

The anti-VEGF antibody, with which Genentech is currently preparing for Phase I clinical trials, targets a molecule that appears to be important in the growth and survival of many solid tumors. Growing tumors secrete vascular endothelial growth factor, VEGF, which promotes the development of new blood vessels and thereby provides the tumors the necessary blood supply to grow. The anti-VEGF antibody is designed to block the VEGF secreted by tumors and potentially stop their growth and spread. It is Genentech's first therapeutic antibody to target a mechanism common to a number of solid tumors rather than a protein marker specific only to certain types of tumors. Therefore, Genentech believes it may have the potential for broad applicability.

This new targeted approach to cancer drug development has the potential to provide cancer patients with exciting new disease fighting biotherapeutics that may not have the serious side effects of conventional therapy.