Enzychem Lifesciences Files for FDA Breakthrough Therapy Designation for EC-18 for the Treatment of Chemoradiation-Induced Oral Mucositis
November 08, 2021 at 01:06 pm EST
Enzychem Lifesciences that the Company has filed for Breakthrough Therapy designation (BTD) with the U.S. Food and Drug Administration (FDA) for the use of its lead investigational candidate in chemoradiation-induced oral mucositis (CRIOM). The BTD filing is based on data from the Company?s Phase 2 trial. FDA Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). Phase 2, randomized, double-blind, placebo-controlled, 2-stage study evaluated EC-18 for Head and Neck Cancer patients with squamous cell cancers of the mouth, oropharynx, hypopharynx and nasopharynx who received standard fractionated intensity-modulated radiotherapy with concomitant chemotherapy (cisplatin). For Stage 2 of the study, 80 patients were randomized into a 1:1 scheme to receive either placebo or 2000 mg of EC-18 as the maximum tolerable dose, determined by the independent Data Safety Monitoring Board in Stage 1.