News & Media
|Hemostemix Receives IRB Approval from the Houston Methodist Hospital Research Institute and the University of California Los Angeles|
|Apr 18 2016 -
Hemostemix Inc. (“Hemostemix” or the “Company”) (TSXV: HEM) (OTCQX: HMTXF), a clinical-stage autologous cell-therapy company, is pleased to announce today the approval of its lead product ACP-01 for critical limb ischemia (CLI) for use in the company’s Phase 2 clinical trial by the Institutions Review Boards of the Houston Methodist Hospital Research Institute and University of California Los Angeles.
Hemostemix previously received clearance of its investigational new drug application for its double blind placebo controlled study to assess bloodderived autologous angiogenic cell precursor therapy in patients with critical limb ischemia from the FDA. Under FDA regulations, Institutions Review Boards (IRBs) are required to review all human subjects research to ensure that the rights and welfare of human subjects are protected at all times. To accomplish this purpose, IRBs are comprised of physicians and research administrators with the authority to approve, require modifications to or disapprove research. The Hemostemix research study and all pertinent study related materials were critically examined by the two IRBs and approved without any modifications.
“IRB approval is an essential step in the process of extending our ongoing international clinical trial to the Houston Methodist DeBakey Heart & Vascular Center and the Ronald Reagan UCLA Medical Center,” explained Dr. Hardean Achneck, M.D., Chief Medical Officer at Hemostemix. “I am especially pleased that we have been able to obtain IRB approval in such a short time from two of the world’s most renowned institutions. Pending the completion of contractual agreements, we are poised to initiate these two additional clinical sites in the U.S.”
“This success is a reflection of our highly professional clinical trial program and follows on the heels of our recent Clinical Research Ethics Board approval of an amended trial protocol by the University of British Columbia for our ongoing clinical trial at the Vancouver General Hospital,” states Hemostemix CEO Dr. Elmar Burchardt, M.D., Ph.D.
About the Houston Methodist DeBakey Heart & Vascular Center
U.S. News & World Report consistently ranks Houston Methodist among the ‘Best Hospitals’ in America and the 2015-16 issue listed Houston Methodist as the No. 1 hospital in the Houston metro area as well as the entire state of Texas. Houston Methodist prides itself with approximately 800,000 outpatient visits per year and is staffed by more than 4,000 physicians. The Houston Methodist DeBakey Heart & Vascular Center is widely regarded as being one of the top cardiovascular programs in the United States. It builds upon the legacy of Dr. Michael E. DeBakey, M.D., a pioneer in heart and vascular surgery, who was personally known to Hemostemix Chief Medical Officer Hardean E. Achneck, M.D.
About the Ronald Reagan UCLA Medical Center
The Ronald Reagan UCLA Medical Center and its affiliated hospitals have been providing state of the art patient care to the people of the greater Los Angeles region and the world for half a century. The UCLA Medical Center is not only one of the most formidable teaching hospitals in the Western United States, but is also ranked by U.S. News & World Report as one of the ‘Best Hospitals’ in the United States in 24 specialty areas (out of a total of 26 specialties assessed). UCLA Medical Center was listed on the ‘Honor Roll,’ and among the best five hospitals nationwide in the 2015-16 issue of U.S. News & World Report. It receives the ‘Highest’ ranking in ‘Patient Volume,’ ‘Advanced Technologies,’ ‘Nursing Intensity’ and ‘Patient Services.’
Hemostemix is a public clinical-stage biotechnology company that develops and commercializes innovative blood-derived cell therapies for medical conditions not adequately addressed by current treatments. It is the first clinical-stage biotech company to test a stem-cell therapy in an international, multicenter, Phase 2 clinical trial for patients with critical limb ischemia (CLI), a severe form of peripheral artery disease (PAD) caused by reduced blood flow to the legs. The Phase 2 trial targets a participant’s diseased tissue with proprietary cells grown from his or her blood that are capable of supporting the formation of new blood vessels. Hemostemix currently enrolls participants in the Phase 2 trial at four sites in South Africa and two sites in Canada. The Company recently received FDA clearance to commence clinical trials in the United States.
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This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential,” and similar expressions, or that events or conditions “will,” “would,” “may,” “could,” or “should” occur. Although Hemostemix believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Hemostemix management on the date such statements were made. Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events, or otherwise.