EMA issues Scientific Advice to Genta's clinical development plan for tesetaxel in patients with gastric cancer

Nov 2 2010

Genta Incorporated (OTCBB: GNTA.OB) today announced that the Company has received Scientific Advice from the European Medicines Agency (EMA) on the Company's clinical development plan for tesetaxel in patients with advanced gastric cancer, which includes a pivotal, randomized, controlled, Phase 3 trial. The EMA's written advice is supportive of Genta's proposed Phase 3 trial in patients with advanced gastric cancer whose disease has progressed on 1^st-line chemotherapy. The EMA issued the advice following its established consultative review process, which provides development clarity toward a potential regulatory submission for marketing approval.

Genta is currently discussing plans for this Phase 3 trial with other regulatory agencies, including the U.S. Food and Drug Administration (FDA). Further information about the trial will be provided upon completion of the Company's ongoing regulatory discussions.

Tesetaxel has been designated an Orphan Drug by both FDA and EMA for treatment of patients with advanced gastric cancer. FDA has also granted Fast Track designation for tesetaxel in patients with advanced gastric cancer.

Source: Genta Incorporated