Hemostemix Inc. (“Hemostemix”) (TSX Venture:HEM; OTCQB:HMTXF) is a publicly traded clinical-stage biotech company that develops and commercializes blood-derived stem cell therapies for medical conditions lacking adequate treatment options. Importantly, it is one of the first clinical-stage biotech companies to test a stem cell therapy within an international, multi-center Phase II clinical trial for patients with critical limb ischemia (“CLI”). CLI is a severe form of peripheral artery disease (“PAD”) that is caused by reduced blood flow to the extremities. After showing promising results in a Phase I trial and with a large number of historical patient treatments performed in open trials, Hemostemix’s Phase II trial targets a participant’s diseased tissue with proprietary cells grown from his or her blood that can support the formation of new blood vessels. This lead cell therapy product is called ACP-01. [Read more…]
CALGARY, Alberta, May 03, 2018 — Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE:HEM) announces that it has treated its first patient under its continuing Phase II Clinical Trial for critical limb ischemia (“CLI”). The first patient was treated at the Vancouver Coastal Health Research Institute (“VCHRI”), a world leader in translational health research for new therapies, led by the principal investigator, Dr. York N. Hsiang, MB ChB MHSc FRCSC. [Read more…]
CALGARY, Alberta, April 19, 2018 – Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE:HEM), a clinical-stage, autologous cell-therapy company, is pleased to announce that the United States Food and Drug Administration (“FDA”) has raised no objections to the Company’s Investigational New Drug (“IND”) application. This allows the Company to expand its Phase II clinical trial for critical limb ischemia (“CLI”) to enroll patients at clinical sites across the United States in addition to Canada, where the Company has already received Health Canada approval. This is a key milestone in the Company’s international Phase II double-blind, randomized, placebo-controlled clinical trial. [Read more…]
Calgary, Alberta, Feb. 23, 2018 — Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE:HEM) is pleased to announce it has finalized the terms of a license agreement (the “License Agreement”) with Aspire Health Science, LLC (“Aspire”) for the Company’s lead therapeutic product technology, ACP-01. ACP-01 is currently the subject of a U.S. Food and Drug Administration (FDA) and Health Canada approved Phase II clinical trial for patients with critical limb ischemia (CLI).
Aspire is an Orlando, Florida based private company focused on the field of stem cell manufacturing as well as related research and development utilizing state-of-the-art FDA cGMP (Current Good Manufacturing Practices) certified laboratory facilities in Orlando, Florida. As previously announced, the Company also recently finalized the terms of a contract manufacturing services agreement (the “Manufacturing Agreement”) with Aspire, formalizing the transition of the Company’s stem cell manufacturing operations from Company owned facilities in Israel to Aspire’s Orlando, Florida facilities. [Read more…]
December 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.
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