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www.fdanews.com/articles/82389-point-therapeutics-announces-results-of-metastatic-melanoma-clinical-program

POINT THERAPEUTICS ANNOUNCES RESULTS OF METASTATIC MELANOMA CLINICAL PROGRAM

November 11, 2005

Point Therapeutics has announced the results of a Phase II single-agent study of its oral anticancer drug candidate, talabostat, in patients with Stage IV melanoma.

The single-agent trial included 42 patients with metastatic melanoma, 31 of whom are evaluable for response. Two patients had a response to talabostat as defined by RECIST (a 30 percent or greater reduction in tumor size), with one of these patients experiencing a complete response, defined as a complete disappearance of the tumor. This patient continues to be a complete responder. The current estimates for single-agent talabostat are 7.1 months for median survival and 1.5 months for median progression-free survival. Additionally, 71 percent of the patients had visceral brain or bone metastases. Left untreated, their median survival would be expected to be approximately 4.4 months.