Enzychem Lifesciences' Fast Track Designation for chemo-radiation induced oral mucositis had been granted by the FDA
ENGLEWOOD CLIFFS, N.J., April 24, 2018 /PRNewswire/ -- On March 14th, the U.S. Food and Drug Administration (FDA) has granted Enzychem Lifesciences, Corp. (KOSDAQ: 183490), one of the fastest growing life sciences company in South Korea's KOSDAQ Stock Exchange, Fast Track Designation of clinical study of EC-18, a synthetic palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol (mosedipimod), to facilitate the research of safety and efficacy in managing chemo-radiation induced oral mucositis (CRIOM).
The US FDA fast track designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill the unmet medical need.
Enzychem Lifesciences' EC-18 is a candidate compound for a new drug with immunomodulation function.
Enzychem Lifesciences successfully completed Phase I clinical trials in Korea and in the United States. Currently, Enzychem is conducting Phase II clinical trials on the indications of Chemotherapy Induced Neutropenia (CIN) and CRIOM. EC-18 was granted Fast Track Designation as it proved potential on oral mucositis treatment, the condition in which lacks an effective medication.
Ki Young Sohn, Chairman and CEO of Enzychem Lifesciences, said "Along with the Orphan Drug Designation granted to EC-18 for Acute Radiation Syndrome (ARS) last December, this Fast Track Designation on CRIOM will expedite the process of clinical trials and global licensing deals."
About Enzychem Lifesciences Corporation
Enzychem Lifesciences, Corp. (KOSDAQ:183490) is a global new drug development biopharmaceutical company founded in 1999. With R&D driven approach and corporate mission of "Saving Human Lives by Overcoming Unmet Medical Needs", Enzychem is developing innovative treatments which can address significant unmet medical needs. Enzychem is one of the fastest growing life sciences company by market capitalization in South Korea's KOSDAQ Stock Exchange. The company is headquartered in Seoul, South Korea.
For more information on Enzychem Lifesciences, visit http://www.enzychem.com/
This discussion may include predictions, estimates or other information that might be considered forward-looking. While these forward-looking statements represent Enzychem's current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this announcement. Please keep in mind that Enzychem is not obligating itself to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events.
The information included in this press release concerns a drug use that has not been approved by the Food and Drug Administration.
SOURCE Enzychem Lifesciences, Corp.
SOURCE Enzychem Lifesciences, Corp.
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