This is a special report, 08 Feb 2018
EVER SUPREME RECEIVED FDA APPROVAL FOR A CLINICAL
PHASE I TRIAL WITH ITS NEW MYOCARDIAL INFARCTION DRUG
Ever Supreme Bio Technology (ESBT) in Taiwan received approval from the US Food and Drug Administration (FDA) for an Investigational New Drug (IND) application on Feb. 08, 2018 to proceed with a clinical Phase I trial of UMSC01 (umbilical cord-derived stem cells) on Myocardial Infarction patients.
ESBT was established in December 2016 as a frontier pharmaceutical research and development (R&D) company dedicated to cell and gene therapies. The company has exclusive rights to the technology transfer for the new drug of UMSC01 from China Medical University based in Taichung, Taiwan. With leadership from Dr. Wen-Liang Huang as the General Manager, a medical expert who comes with more than 40 years of clinical experiences and a highly respected leader of Institutional Review Board / Ethics Committee (IRB/EC), as well as Dr. Hsiu-Ling Hsiao as the Chief Scientist Officer, with more than 20 years of R&D experience in the international pharmaceutical arena in Europe and North America, ESBT has moved forward undauntedly in exploring the field of regenerative medicines. With much efforts, this IND approval from the FDA brings about an encouraging news not only for the people involved with the project and the company, but also for Myocardial Infarction patients, as it is a major milestone in the advancement of Regenerative medicine in Taiwan and one the few domestic cell therapy clinical trials that had gone through the process of FDA approval.
Looking forward, ESBT will continue its R&D efforts to dedicate in exploring and refinement of new cell-innovative therapies. As always, the company, with patients in mind, wishes to bring new options for safe and effective treatments.