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Biotech / Medical : Welcome to the POTP board, the DPP-IV company

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To: rkrw who wrote (77)	5/21/2007 8:19:44 AM
From: rkrw	Read Replies (1) of 90

Yet another small, open label, non placebo controlled phase II bombing in phase III. See it again and again, docs know how to pick good open label patients. Or are responses exaggerated? Talabostat Clinical Program Put on Clinical Hold by FDA Monday May 21, 8:00 am ET Decision Based on Results of the Interim Analyses of the Talabostat Phase 3 Program in Lung Cancer BOSTON--(BUSINESS WIRE)--Point Therapeutics, Inc. (NASDAQ: POTP - News) today announced that the U.S. Food and Drug Administration (FDA) has placed the clinical program for talabostat on clinical hold as a result of the interim analyses of the Company's two Phase 3 talabostat studies as a potential treatment for patients with advanced non-small cell lung cancer (NSCLC). The Company's Independent Data Monitoring Committee recommended stopping both studies due to neither the primary endpoint of median progression-free survival (PFS) nor the secondary endpoint of overall survival demonstrating improvement over the placebo groups. In addition, in the talabostat combination trial with docetaxal (Taxotere®: sanofi-aventis), the talabostat arm of the study demonstrated significantly lower overall survival than the placebo arm. As a result of the Company informing the FDA of the interim results, the FDA has put the Company's talabostat clinical program on hold. "We are obviously surprised and disappointed with the results of both Phase 3 studies," said Don Kiepert, President and CEO. "We are focusing on the best interests of the patients and making sure all this information is being communicated to the appropriate medical and regulatory authorities as quickly as possible. We are also assessing our options given this data and will report on next steps once they have been decided." Talabostat's NSCLC program consisted of two randomized, placebo-controlled, double-blind Phase 3 studies in the second-line and third-line setting. The first Phase 3 study evaluated talabostat and pemetrexed (Alimta® : Eli Lilly) versus placebo and pemetrexed. The second Phase 3 study evaluated talabostat and docetaxal versus placebo and docetaxal. The primary endpoint in both studies was PFS with overall survival as a secondary endpoint. About Point Therapeutics, Inc.:

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