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
-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.
About Scientific Advice
Scientific Advice is a procedure offered by the EMA to stakeholders for clarification of questions arising during development of medicinal products. The scope of Scientific Advice is limited to scientific issues, i.e. to quality, non-clinical, and clinical aspects of the concerned medicinal product not yet unequivocally covered by published scientific guidelines. Scientific Advice focuses on development strategies rather than pre-evaluation of data to support a Marketing Authorization Application. Scientific Advice is legally non-binding and is based on current scientific knowledge that may be subject to future changes.
Taxanes (including paclitaxel and docetaxel) are the most widely used chemotherapy drug class in cancer medicine. However, these agents are associated with serious safety issues, particularly hypersensitivity reactions related to intravenous infusions that are occasionally fatal and that require premedication and careful observation. Other prominent side-effects of this drug class include myelosuppression (low blood counts) and peripheral neuropathy (disabling nerve damage).