ACT Biotech Files Special Protocol Assessment With FDA for Phase 3 Trial of Telatinib for Front-Line Treatment of Stomach Cancer
2/28/2011 9:47:26 AM
SAN FRANCISCO, Feb. 28, 2011 (GLOBE NEWSWIRE) -- ACT Biotech, Inc., a biopharmaceutical company focused on the development of highly targeted, oral therapeutics for the treatment of cancer, announced today that it has filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) related to a randomized Phase 3 trial of telatinib in combination with chemotherapy for the first-line treatment of patients with advanced stomach cancer. The FDA's SPA program is in place to allow the FDA to review and comment on clinical trial protocols, the data from which will form the primary basis of an efficacy claim for drug registration.
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