Thursday, Apr 8, 1999
SOUTH SAN FRANCISCO, Calif. -- April 8, 1999 -- Genentech, Inc. (NYSE: GNE) announced today that the Phase III clinical trial of the company's recombinant human nerve growth factor (rhNGF) for use in treating patients with diabetic peripheral neuropathy did not meet its objectives. Consequently, Genentech does not intend to file a biologics license application with the U.S. Food and Drug Administration.
"Based on the promising results of the Phase II study, we are disappointed in the preliminary findings of this trial," said Arthur D. Levinson, Ph.D., Genentech's president and chief executive officer. "We are thoroughly analyzing the data to better understand the results and are reviewing future plans for rhNGF research."
In the United States, Genentech conducted a multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of rhNGF in patients with diabetic peripheral neuropathy. The primary endpoint was to demonstrate that a greater proportion of rhNGF-treated patients than placebo-treated patients had improvements in nerve function after 12 months of treatment. Nerve function was assessed using the quantitative neurological exam, the Neuropathy Impairment Score of the Lower Limbs (NIS-LL). The study involved 84 centers around the country and 1,019 patients (with both type 1 and type 2 diabetes) with symptomatic and asymptomatic diabetic peripheral neuropathy.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Twelve of the currently marketed biotechnology products stem from Genentech science. Genentech markets seven biotechnology products directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange and the Pacific Exchange under the symbol GNE.
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