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Positive Interim Results Reported for Phase 2 Single-Agent Study of Talabostat in Advanced Metastatic Melanoma

BOSTON--(BUSINESS WIRE)--Feb. 15, 2005--Point Therapeutics, Inc. (NASDAQ:POTP - News) announced today that it has successfully completed the first stage of the Company's Phase 2 single-agent study of talabostat in patients with advanced metastatic melanoma. The desired level of tumor response has been observed, allowing the Company to continue accruing patients for the second stage of the study. This is the first study to evaluate the Company's oral lead product candidate, talabostat (PT-100), as a single agent in patients with advanced metastatic melanoma.

Of the first third of evaluable patients enrolled in this 30 patient study, a partial tumor response (defined as a tumor reduction of at least 30 percent) has been observed in a melanoma patient with lung metastases who previously failed IL-2 treatment. "We are extremely pleased to reach this significant milestone," said Don Kiepert, President and CEO of Point Therapeutics. "Importantly, this study shows the anti-tumor impact of talabostat without the effects of other therapies. In our other three on-going Phase 2 clinical studies, talabostat is being combined with other anti-cancer agents."

"Patients with advanced metastatic melanoma do not have many treatment options", said Dr. Casey Cunningham from the Mary Crowley Medical Research center in Dallas, Texas, one of the lead investigators in this study,. "The results observed thus far with talabostat as a single-agent treatment for patients with metastatic melanoma are very encouraging. These results, combined with the results previously reported in combination with docetaxel in patients with non-small cell lung cancer (NSCLC) are establishing human proof of principle for talabostat as an anti-tumor agent."

The trial is an open-label, single-arm study in up to 30 evaluable patients with advanced metastatic melanoma. The primary study endpoint is tumor response. Talabostat is being administered orally for 14 consecutive days followed by a 7 day rest period for up to six treatment cycles. Talabostat is an inhibitor of dipeptidyl peptidases, such as fibroblast activation protein (FAP), found in the stroma of tumors. The Company is currently studying talabostat in four Phase 2 clinical studies in three different tumor types. The Company had previously announced on November 30, 2004 that it successfully completed the first stage of a two-stage clinical study in patients with NSCLC.

Source: Point Therapeutics, Inc.

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