Genta Submits Randomized Study Of Tesetaxel In Patients With Advanced Gastric Cancer To FDA For Special Protocol Assessment

News — By on February 27, 2009 at 3:25 am

BERKELEY HEIGHTS, N.J. — Genta Incorporated announced today that the Company has submitted a proposal to the Food and Drug Administration for a randomized clinical trial of tesetaxel, an oral taxane chemotherapy compound, for Special Protocol Assessment (SPA). A SPA is intended to secure agreement on the design, size, and endpoints of clinical trials that are intended to form the primary basis of an efficacy claim in a New Drug Application (NDA). Genta also expects to seek Scientific Advice from the European Medicines Agency (EMEA) for this study to support a Marketing Authorization Application (MAA). The Company believes tesetaxel is the leading oral taxane currently in clinical development. The proposed protocol will e…

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