Enzychem Lifesciences, Corp. (KOSDAQ: 183490) announced today that the company has achieved a huge milestone by completing enrollment of the required 24 patients in Stage 1 of the Phase 2 CRIOM (Chemoradiation Induced Oral Mucositis) study.
Stage 1 of the Phase 2 CRIOM study evaluates the maximum tolerable dose of EC-18 which will be used in Stage 2 of the study. Patient enrollment for Stage 2 is expected to begin in 2Q 2019. Enzychem has received Fast Track Designation by the U.S. Food and Drug Administration for the Phase 2 study evaluating lead investigational candidate EC-18 in CRIOM.
Enzychem’s lead investigational candidate EC-18, is in development for a variety of indications including Chemotherapy Induced Neutropenia (CIN), Chemoradiation Induced Oral Mucositis (CRIOM), and Acute Radiation Syndrome (ARS). Enzychem Lifesciences was awarded U.S. FDA Fast Track Designation for EC-18 in CRIOM and FDA Orphan Drug Designation in ARS. CIN and CRIOM are in Phase II clinical trials and a pivotal study evaluating EC-18 in ARS is expected to begin under FDA’s animal rule guidance.