Genta Receives Fast Track Status by FDA for Tesetaxel

11 April 2010 (Last Updated April 11th, 2010 18:30)

Genta said it received fast track designation for its advanced gastric cancer drug candidate tesetaxel from US FDA. Following positive results from a Phase 2a trial, Genta is conducting a confirmatory Phase 2b trial as second line treatment in patients with advanced gastric cancer.

Genta said it received fast track designation for its advanced gastric cancer drug candidate tesetaxel from US FDA.

Following positive results from a Phase 2a trial, Genta is conducting a confirmatory Phase 2b trial as second line treatment in patients with advanced gastric cancer.

A dose-ranging and pharmacokinetic study of tesetaxel in combination with capecitabine has also been completed.

Genta has prepared a clinical protocol and trial design for a Phase 3 trial.

Genta plans to submit its Phase 3 trial data to the FDA in the second quarter of this year in order to get a Special Protocol Assessment (SPA).