Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell L...( - Phase 2 Median Overall Survival Co...),Health

- Phase 2 Median Overall Survival Confirmed and Extended at the 12th World

Conference on Lung Cancer in Seoul -

SOUTH SAN FRANCISCO, Calif., Sept. 5 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today announced that it has been granted fast track designation by the U.S. Food and Drug Administration (FDA) for its lead product candidate, picoplatin, for the second-line treatment of refractory or resistant small cell lung cancer (SCLC). Picoplatin is currently being studied in the pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial in SCLC, which is evaluating overall survival as the primary endpoint and is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Yesterday, Poniard presented updated data from its Phase 2 SCLC trial at the 12th World Conference on Lung Cancer in Seoul, which confirmed and extended a median overall survival of 27 weeks (based on an analysis of 63 patients), which compares favorably to a median survival of approximately 17 to 22 weeks for patients who receive other second-line chemotherapy according to the 2007 National Comprehensive Cancer Network practice guidelines.

"Our receipt of fast track designation is the result of our ongoing communications with the FDA, and has the potential to accelerate the development of picoplatin for the treatment of small cell lung cancer, a difficult-to-treat disease, and a patient population with very limited treatment options," said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "We are focused on executing our ongoing Phase 3 SPEAR trial to facilitate the expeditious filing of a New Drug Application
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