FDA grants "Fast Track" designation for Genta’s advanced gastric cancer drug tesetaxel

Apr 7 2010

Genta Incorporated (OTCBB: GETA.OB) today announced that the U.S. Food and Drug Administration (FDA) has granted the Company's request for "Fast Track" designation of tesetaxel for treatment of patients with . Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.

Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The designation typically enables a Company to submit a New Drug Application (NDA) on a "rolling" basis with ongoing FDA review during the submission process. NDAs with Fast Track designation are also usually granted priority review by FDA at the time of submission.

Based on promising results in a Phase 2a trial, Genta is conducting a confirmatory Phase 2b trial of tesetaxel as 2^nd-line treatment in patients with advanced gastric cancer who have failed a single 1^st-line regimen. As defined, the 1^st-line regimen must comprise a platinum-containing compound (cisplatin, carboplatin, or oxaliplatin) and a fluoropyrimidine (5-fluorouracil, capecitabine, or S-1). The Fast Track designation targets the patient population that is enrolling in the Phase 2b trial.

Genta has formulated a trial design and clinical protocol for a randomized, double-blind, placebo-controlled Phase 3 trial of tesetaxel in this patient population. In developing the trial, the Company completed a dose-ranging and pharmacokinetic study of tesetaxel plus capecitabine (Xeloda^®; Hoffmann LaRoche, Inc.). Results from that study showed that full doses of each of these orally administered drugs could be administered together without causing overlapping side-effects.

Genta plans to submit its proposed Phase 3 trial to FDA in the 2^nd-quarter in order to secure a Special Protocol Assessment (SPA). The Company looks forward to meeting with the FDA to discuss the trial design.