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).