ENGLEWOOD CLIFFS, N.J., Feb. 21, 2019 /PRNewswire/ — 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.
About Enzychem Lifesciences Corporation
Enzychem Lifesciences, Corp. (KOSDAQ:183490) is a global biopharmaceutical company headquartered in Seoul, Korea, which is dedicated to developing new drugs and APIs (Active Pharmaceutical Ingredients). Since its foundation in 1999, Enzychem Lifesciences has been striving to develop new and innovative treatments capable of addressing unmet medical needs with R&D-driven approaches under its grand mission of “Saving Human Lives by Overcoming Unmet Medical Needs”
EC-18, the lead compound of Enzychem Lifesciences, is an immune modulator driven from deer antler that has the potential to be used for a variety of indications. At present, three clinical trials for different indications are being conducted; Chemotherapy Induced Neutropenia (CIN), Chemoradiation Induced Oral Mucositis (CRIOM), and Acute Radiation Syndrome (ARS). In order to facilitate the clinical trial process, Enzychem launched a US operation office in New Jersey on June 28, 2018.
Currently, Enzychem Lifesciences is one of the fastest growing life science companies in KOSDAQ Stock Exchange in terms of market capitalization. The company is headquartered in Seoul, 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.
Media Contact: Ted Kim (Manager of Business Development)