Point Therapeutics (POTP) Announces Finalization of Data from Phase 2 Non-Small Cell Lung Cancer Study

December 21, 2006 8:29 AM EST

Point Therapeutics, Inc. (NASDAQ: POTP) announced finalization of progression-free survival (PFS), survival and response data from the Company's completed Phase 2 open label, single-arm, multi-center study of talabostat in combination with docetaxel in patients with Stage IIIB/IV non-small cell lung cancer (NSCLC).

The primary endpoint was overall objective response rate in the evaluable population based on the World Health Organization (WHO) measure of a 50% or greater reduction in tumor size. Secondary efficacy endpoints included PFS and overall survival.

Point's Phase 3 NSCLC program consists of two randomized, double blind placebo controlled trials in up to 800 patients at approximately 100 sites in North America. The first trial evaluates the combination of talabostat with docetaxel versus placebo and docetaxel. The second trial evaluates the combination of talabostat with pemetrexed versus placebo and pemetrexed. The primary study endpoint is progression-free survival. Secondary endpoints include overall survival, objective tumor response, duration of response and quality of life. Both Phase 3 studies continue to enroll patients and Point anticipates having results by the end of 2007. With positive results, the Company would initiate the filing of a New Drug Application in early 2008.

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