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Biotech / Medical : Welcome to the POTP board, the DPP-IV company -- Ignore unavailable to you. Want to Upgrade?

To: rkrw who wrote (77)	5/15/2007 11:03:39 AM
From: pgo-neil	Read Replies (2) \| Respond to of 90

Hi Jim, Thanks for the PR notice... Obviously they are scrambling for some positive news to allow them to raise capital quickly. I think even in a life boat drill, they only have about 4 to 7 months cash in the till. A couple of points that might be relevant: 1. Timing... if they complete this month, they should be able to get the results in a late breaking poster for ASCO. As late as March, they were projecting a complete enrollment [N=400] in the second quarter. To find in the middle of May that they are still 40 away shows a slowing of enrollment. 2. The Ph2 Pancreatic is still being followed and they announced in March that they expected to complete the trial in the second quarter and report. Even though they were going to miss 6 month survival, they did have 5 Responses out of 51 evaluable. Another 19 patients could move into evaluable for the completed follow-up. Maybe they will have some other ASCO news... Or maybe it will be too late... or maybe not very good news either. A question [with relevance to DNDN]... I would think this unscheduled peek would have to be coordinated and approved by the FDA [the stat analysis as a minimum]. But I don't find any reference to that sort of coordination in the PR. How standard is this approach [with or without FDA approval]?

To: rkrw who wrote (77)	5/21/2007 8:19:44 AM
From: rkrw	Read Replies (1) \| Respond to 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.: