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.