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news.Point Therapeutics has successfully completed the first stage of its phase II single-agent study of talabostat in patients with advanced metastatic melanoma. As the desired level of tumor response has been observed, Point may now continue accruing patients for the second stage of the study.
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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. 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.
Of the first third of evaluable patients enrolled in this 30 patient study, a partial tumor response (tumor reduction of at least 30%) 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. “Importantly, this study shows the anti-tumor impact of talabostat without the effects of other therapies. In our other three on-going phase II clinical studies, talabostat is being combined with other anticancer agents.”
Talabostat is an inhibitor of dipeptidyl peptidases, such as fibroblast activation protein (FAP), found in the stroma of tumors. Point is currently studying talabostat in four phase II clinical studies in three different tumor types.