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Hemostemix Poised to Expand Phase-2 Clinical Trial of Lead Product ACP-01 to the United States
Dec 22 2015 -

Toronto, Ontario

Hemostemix Inc. (“Hemostemix” or the “Company”) (TSXV: HEM), a clinical-stage autologous cell-therapy company, announced today the Company’s progress in expanding the international, multicenter, phase-2 clinical trial of its lead product ACP-01 for critical limb ischemia (CLI) to the United States.

The ongoing phase-2 clinical trial investigates the safety and efficacy of 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. The clinical trial currently recruits patient at two sites in Canada and four sites in South Africa.

“After receiving clearance from the FDA to recruit patients in the United States, we’ve been engaged in a multistep site-initiation process with qualified medical centers that involves executing nondisclosure agreements and discussing our clinical trial protocol,” said Dr. Hardean E. Achneck, vice president of clinical research and operations at Hemostemix. “I’m encouraged and inspired by the positive feedback on the design of our clinical trial that we’ve been receiving from vascular surgeons at such leading U.S. medical centers as Houston Methodist DeBakey Heart & Vascular Center, University of California Davis Vascular Center, Ronald Reagan UCLA Medical Center, Temple University, Malcom Randall Veterans Affairs Medical Center, and Yale University. We are discussing the terms of contractual agreements with some of these sites, and several sites are currently in the process of submitting study documents to their respective institutional review boards.”

“Leading medical centers in the United States are increasingly recognizing the groundbreaking potential of our lead product ACP-01 for the treatment of CLI,” said Dr. Elmar Burchardt, Hemostemix president and CEO. “There is tremendous need for a therapy that reduces the number of limb amputations and improves survival. ACP-01 gives hope to patients who suffer from CLI and to physicians who lack other treatment options.”

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.

For more information, email office@hemostemix.com.

Neither the TSX Venture Exchange, Inc. nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements
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.

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