Hemostemix Announces Enrollment Milestone in the ACP-01 Phase II Critical Limb Ischemia Clinical Trial
CALGARY, Alberta, April 09, 2019 (GLOBE NEWSWIRE) -- Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE: HEM; OTCQB: HMTXF) is pleased to announce that it has reached an enrollment milestone in its continuing Phase II Clinical Trial for critical limb ischemia (“CLI”).
Enrollment rates have increased substantially over the past several weeks, with an additional nine (9) patients enrolled and treated under the Company’s CLI clinical trial protocol. A total of thirty-three (33) patients have been treated to date, representing over one third of the total trial enrollment goal.
The Company currently has twelve (12) trial sites open, of which eleven are located in the United States and one in Vancouver, Canada, that are actively screening patients for enrollment in the study. The Company has additional clinical trial sites starting up in Canada and the United States. The Company has been successful in attracting investigators that are top of their field vascular surgeons and podiatrists who are highly regarded for treating CLI patients. The Company continues to see positive interest in ACP-01 as a treatment for advanced CLI patients facing this life-threatening condition and imminent lower extremity amputations.
The clinical trial is a randomized, placebo-controlled, double blind Phase II trial of the safety and efficacy of ACP-01 in patients with advanced CLI who have exhausted all surgical and medical treatment options. Under the current USA Food and Drug Administration (“FDA”) and Health Canada approved protocol, approximately 95 patients will be treated with ACP-01 and followed for twelve months. The Company’s patented ACP-01 autologous stem cells have been shown in previous clinical studies to stimulate the generation of new blood vessels in CLI patients and improve amputation-free survival. ACP-01 is derived from the patient’s own blood, expanded in culture and then re-injected into the diseased tissue.
“This escalation in patient enrollment is a direct result of the Company’s expanded internal team working closely with our clinical trial sites to support their efforts and increase patient enrollment. Over the past few months, we have also added several key trial sites in the United States. We see this increase in enrollment and the addition of new clinical trial sites as a strong indication of the importance of a treatment for these no-option critical limb ischemia patients” states Dr. Alan Jacobs, Chief Medical Officer and President of Hemostemix. “We expect to continue to see our enrollment figures escalate as we move towards the interim analysis.”
ABOUT HEMOSTEMIX INC.
Hemostemix is a publicly traded 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 II 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 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. The Company’s intellectual property portfolio includes over 50 patents issued or pending throughout the world. Hemostemix has a manufacturing contract with Aspire Health Science, LLP (“Aspire”), for the production of ACP-01 and for research and development purposes at Aspire’s Orlando, Florida, facility. Building towards commercialization, Hemostemix has also licensed the use, sale and import of ACP-01 for certain indications to Aspire in certain jurisdictions. The Company is continuing research and development of its lead product, ACP-01 with other applications, including cardiovascular, neurological and vascular indications.
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Contact:
Kyle Makofka, CEO
Suite 2150, 300 – 5th Avenue S.W.
Calgary, Alberta T2P 3C4
Phone: (403) 506-3373
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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. By their nature forward-looking statements are subject to known and unknown risks, uncertainties, and other factors which may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the Company’s stage of development, future clinical trial results, long-term capital requirements and future ability to fund operations, future developments in the Company’s markets and the markets in which it expects to compete, risks associated with its strategic alliances and the impact of entering new markets on the Company’s operations. Each factor should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. 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.
