Hemostemix Holds First Meeting of Data Safety Monitoring Board (DSMB)August 20, 2015
Hemostemix Inc. (“Hemostemix” or the “Company”) (TSXV: HEM), a clinical-stage autologous cell-therapy company that has treated 15 of 100 patients in its international phase-2 clinical trial for critical limb ischemia (CLI), announced the first meeting of its Data Safety Monitoring Board (DSMB). Governed by regulations from the National Institutes of Health (NIH), the DSMB is comprised of independent experts who oversee the safety and conduct of the Hemostemix trial.
Experts on the Hemostemix DSMB include:
- Armand Keating, MD, FRCPC, director of the Cell Therapy Program at the Philip S. Orsino Facility for Cell Therapy and professor of medicine at the Princess Margaret Cancer Centre, University of Toronto, Canada
- Richard McLain, biostatistician at PFP Statistical Consulting, LLC, Detroit, Michigan, USA (previously 20-year associate director of Pfizer Global Research & Development, Ann Arbor, Michigan)
- Anthony Comerota, MD, FACS, FACC, director of the Jobst Vascular Institute at ProMedica Toledo Hospital, Toledo, Ohio, USA
“Following the recent Food and Drug Administration clearance of the Company’s Investigational New Drug application to expand our phase-2 trial for CLI to clinical sites across the United States, our top priority continues to be conducting our clinical trial safely,” said Dr. Hardean E. Achneck, vice president of clinical research and operations at Hemostemix. “We feel privileged that the safety of our trial is being monitored by such an outstanding team of prominent physicians and scientists in the fields of vascular surgery, biostatistics, and cell therapy.”
About Critical Limb Ischemia (CLI)
CLI is a severe form of peripheral artery disease (PAD) caused by reduced blood flow to the legs. About half of CLI patients either die or require amputation of the affected limb within one year of diagnosis. Demand for a treatment is on the rise, as CLI predominately affects the growing population aged 50 and older.
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