BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--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 1st-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.
