Policy & Regulation
Enzychem Lifesciences awarded US FDA fast track designation for chemo-radiation induced oral mucositis
25 April 2018 -

Life sciences company Enzychem Lifesciences Corp (KOSDAQ:183490) reported on Tuesday the receipt of US Food and Drug Administration (FDA) Fast Track Designation of its clinical study of EC-18 to facilitate the research of safety and efficacy in managing chemo-radiation induced oral mucositis (CRIOM).

The South Korean company said EC-18 is a synthetic palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol (mosedipimod) and is a candidate compound for a new drug with immunomodulation function.

Following successful Phase I clinical trials in Korea and in the US, the company is conducting Phase II clinical trials on the indications of Chemotherapy Induced Neutropenia (CIN) and CRIOM.

According to the company, EC-18 was granted US FDA Fast Track Designation to expedite the process of clinical trials and global licensing deals as it proved potential on oral mucositis treatment, the condition in which lacks an effective medication.