Point Reports Positive Phase II Interim Results in Talabostat Study

Point Therapeutics has successfully completed the first stage of the company's Phase II 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 study is the first 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.

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 seven-day rest period for up to six treatment cycles. Talabostat is an inhibitor of dipeptidyl peptidases, such as fibroblast activation protein, found in the stroma of tumors.

The company is currently studying talabostat in four Phase II clinical studies in three different tumor types.