Tuesday, Oct 15, 1996
South San Francisco, Calif. -- October 15, 1996 --Based on promising results of the Phase II trial of Nerve Growth Factor (NGF) in diabetic peripheral neuropathy, Genentech, Inc. (NYSE: GNE) announced today it will advance clinical study of this potential new therapy to late-stage, or Phase III. Genentech also announced that its majority stockholder, Roche, exercised its option, per Genentech's 1995 arrangement with Roche, to develop NGF outside the United States. As a result of Roche's opt-in for NGF, Genentech will record contract revenues of $28.4 million in the third quarter of 1996.
Phase II trial results were presented today at the 121st annual American Neurological Association (ANA) meeting in Miami. Stuart C. Apfel, M.D., of the Albert Einstein College of Medicine, presented the results of the six month trial of NGF in diabetic patients with peripheral neuropathy. The trial included 250 patients at 15 sites in the United States. It showed that NGF significantly improved neurological function and the sensations of cooling detection and of heat measured as pain by well accepted neurological function tests. NGF was generally well tolerated.
There are approximately eight million diagnosed diabetics in the United States, of whom 20 percent (1.6 million people) have symptomatic peripheral neuropathy. This damage can lead to serious complications such as repeated limb injury and chronic sores, possibly leading to limb amputation. There is currently no effective therapy for this disorder.
"Our Phase II results for NGF are sufficiently encouraging for Genentech to make the scientific and financial commitment to advance its clinical development with our partner, Roche, " said Arthur D. Levinson, Ph.D., Genentech's President and Chief Executive Officer. "A therapy for diabetic peripheral neuropathy is truly an unmet medical need, and we are excited to pursue NGF's potential to treat this serious disease."
Currently scheduled to begin by the end of the year with results available in 1998, Phase III trials will seek to confirm and expand these results for the purpose of applying for regulatory approval in the United States. Roche will conduct pivotal trials outside the United States for marketing registration there. Genentech and Roche will combine efforts where appropriate to expedite development.
Genentech's Phase III trial, in approximately 1,600 diabetic patients with peripheral neuropathy, will target various endpoints. The primary end point will be improvement in objective tests of neurological functions, such as was seen in the Phase II results. A secondary end point will be a subjective measure of the patients' perception of benefit based on questionnaire responses about symptom improvement.
NGF is one of a family of natural human proteins known to stimulate the growth and survival of neurons in the nervous system. In diabetic peripheral neuropathy, small sensory neurons in the feet, legs and hands are affected, resulting in spontaneous pain, numbness and other abnormal sensations, such as burning or tingling. NGF specifically targets small sensory neurons of the peripheral nervous system (the nerves that receive stimulation from outside the body, such as the sense of touch from the skin and ability to perceive pain), potentially promoting their survival, growth and regeneration.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Ten of the currently marketed biotechnology products stem from Genentech science, five of which Genentech markets directly in the United States. Genentech is headquartered in South San Francisco, California, and is traded on the New York and Pacific Stock Exchanges under the symbol GNE.
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