Hemostemix Enrolls Fifth Participant at Vancouver General Hospital in International Phase-2 Clinical Trial for Critical Limb IschemiaJune 25, 2015
Multicenter, double-blind, placebo-controlled trial currently recruits participants at six sites across Canada and South Africa under the same clinical protocol
Hemostemix Inc. (“Hemostemix” or the “Company”) (TSXV: HEM), a clinical-stage autologous cell-therapy company, announced a milestone today in its international phase-2 clinical trial for critical limb ischemia (CLI): treatment at Vancouver General Hospital of the site’s fifth participant. The double-blind, randomized, placebo-controlled trial currently recruits participants at six sites in Canada and South Africa under the same clinical protocol and to date has enrolled 15 out of approximately 100 participants with CLI.
The trial studies the efficacy of the company’s lead product, ACP-01, which uses angiogenic progenitor cells to combat the life-threatening complications of CLI. These proprietary cells are grown from a patient’s own blood and, once injected into his or her diseased tissue, are able to support the formation of new blood vessels.
Dr. York Hsiang, a research scientist with the Vancouver Coastal Health Research Institute and a distinguished professor of vascular surgery at the University of British Columbia, serves as principal investigator for the trial at Vancouver General Hospital. “I’m proud to help lead this clinical trial in Canada,” said Dr. Hsiang. “Critical limb ischemia is a terrible disease that threatens not only the quality of life, but life itself. Having worked extensively with CLI patients, I’m excited to explore a nonsurgical, regenerative cell therapy for CLI, such as ACP-01.”
“Enrolling our fifth participant in Vancouver on the heels of enrolling our first participant in South Africa demonstrates the integrity of our international clinical protocol and growing momentum of the trial,” said Dr. Hardean Achneck, vice president of clinical research and operations at Hemostemix.
“Our ability to conduct a multicenter, double-blind, and placebo-controlled trial across international sites under the same clinical protocol ensures a robust data pool and lays a strong foundation for developing a nonsurgical, regenerative cell therapy to treat CLI,” said Dr. Elmar Burchardt, president and CEO of Hemostemix.
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.
About Vancouver Coastal Health Research Institute (VCHRI)
VCHRI, a world leader in translational health research, is the research body of Vancouver Coastal Health Authority. VCHRI includes three of British Columbia’s largest academic and teaching health sciences centres—Vancouver General Hospital, University of British Columbia (UBC) Hospital, and GF Strong Rehabilitation Centre—as well as many other hospitals and public health agencies across Vancouver Coastal Health. VCHRI is academically affiliated with the UBC Faculty of Medicine and is one of Canada’s top-funded research centres receiving from $80 million to $100 million in research funding annually. More than 1500 personnel are engaged in a variety of research centres, research programs, and evolving research areas. For more information, visit vchri.ca.
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