Point Therapeutics (POTP) Says FDA Places Talabostat Clinical Trial on Hold, Shows Lower Overall Survival Rate Than Placebo
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- Point Therapeutics (POTP) Says FDA Places Talabostat Clinical Trial on Hold, Shows Lower Overall Survival Rate Than Placebo
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Point Therapeutics, Inc. (NASDAQ: POTP) 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.
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