Toronto, Ontario (PRWEB) December 20, 2013
Hemostemix Ltd. announced today the formation and inaugural meeting of a clinical trial steering committee to guide the company in optimizing all aspects of the upcoming Phase 2 trial for its lead product, ACP-01, in patients with critical limb ischemia.
As well-respected specialists in critical limb ischemia and vascular surgery, the role of the Clinical Trial Steering Committee will be to advise the Company on all matters critical to the trial’s success.
“We are extremely honored with the caliber of key opinion leaders who have committed to providing us with their expertise on the trial’s design, implementation, sites, enrollment criteria, and several other critical parameters,” stated Hemostemix Founder and President, Dr. Valentin Fulga.
“We believe we have a real opportunity to learn valuable lessons from the committee’s collective experience in the space and translate that into a successful trial. The committee is providing valuable input in this regard,” continues Dr. Fulga, “and we were pleased to have what proved to be a very valuable inaugural meeting this week in Toronto.”
The committee is comprised of prominent clinician scientists, namely:
Mohammed Al-Omran, MD is Professor of Surgery at University of Toronto and King Saud University and Chief of Vascular Surgery Division at St Michael’s Hospital. Dr. Al-Omran is a clinician investigator and currently appointed as a Scientist at the Li Ka Shing Knowledge Institute of St. Michael’s Hospital. His research interests are focused on atherosclerosis bench to bedside with special interest in peripheral arterial disease.
- Elmar R. Burchardt, MD, PhD, DS., is Professor of Clinical Pharmacology at the University of Witten in Germany. Dr. Burchardt has over 20 years of academic and industry experience in the areas of cell therapy, hematology, inflammation and cardiovascular diseases. He has designed and completed over 40 clinical trials with cell therapy and biological products in North America, Europe and other regions of the world, resulting in several marketing authorizations- As Vice President, Elmar initiated and successfully completed Aastrom Bioscience’s US-based phase II clinical cell therapy trials in Critical Limb Ischemia and Dilated Cardiomyopathy.
- York N. Hsiang, MB. ChB, MHS., FRCSC, is Professor of Vascular Surgery at the University of British Columbia and Consultant Surgeon at the Vancouver General Hospital, Vancouver, B.C. He has been the Professor of Surgery at the University of British Columbia in the Division of Vascular Surgery since July 2000. Dr. Hsiang has Specialty Board Qualifications in General Surgery (FRCSC 1986), Special Competence in Vascular Surgery (1987), and MHSc. (Clinical Epidemiology and Biostatistics, UBC, 1987-88).
- Thomas F. Lindsay, MD is Professor of Surgery and Chair of the Division of Vascular Surgery at the University of Toronto. He is head of the Division of Vascular Surgery within the Peter Monk Cardiac Center at University Health Network and Chair of the Royal College of Physicians and Surgeon of Canada Vascular Surgery Specialty Committee.
- Mark Jay Zucker, MD, JD, FACC, FAC is the Company’s Scientific Advisory Board representative on the clinical steering committee. Dr. Zucker is Director of the Harvey and Georgina Weinstein National Heart Transplant Center at Newark Beth Israel Medical Center and Clinical Professor of Medicine at the University of Medicine and Dentistry of New Jersey, New Jersey Medical School, Newark, N.J. He has been a principal or co-investigator on more than 40 trials including trials of cell-based therapies such as the BioHeart myoblast trial and the Baxter RENEW trial.
The steering committee meeting was lead by Company Founder and President, Dr. Valentin Fulga, with critical support and participation from the company’s new Medical Director, Dr. Eli Braude.
About Hemostemix Ltd
Hemostemix Ltd is a Canadian-Israeli company developing and commercializing innovative blood-derived cell therapies for medical conditions not adequately addressed by current treatments with an operating research, development and manufacturing facility in Kiryat Weizmann Science Park, Ness Ziona. For more information see http://www.hemostemix.com.