Hemostemix Announces First U.S. Patients Treated in Phase II Clinical Trial
CALGARY, Alberta, July 18, 2018 (GLOBE NEWSWIRE) -- Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE:HEM) is pleased to announce that it has treated three additional patients including its first two patients in the United States under its continuing Phase II Clinical Trial for critical limb ischemia (“CLI”). The first two US patients were treated at Clinical Research of Central Florida located in Winter Haven in central Florida, led by the principal investigator, Dr. C. Jake Lambert, M.D. An additional patient was also recently treated at Vancouver Coastal Heath Research Institute (“VCHRI”) located in Vancouver, BC, resulting in a total of eleven patients being treated at this facility to date under the trial. As a result of these new patient treatments, we have a total of thirteen patient treatments completed at the four currently enrolled facilities to date.
As previously announced, the Company currently has four trial sites open for patient enrollment, including three trial sites in Florida and one in Canada that are all actively screening patients for enrollment in the study. The Company has approximately fifteen additional clinical trial sites located in Canada and the United States that are in various stages of the on-boarding process including eight sites that are near finalization with six of these having approved the Company’s clinical trial agreement pending final review board or budget approvals, which the Company expects will be greenlighted shortly.
The ongoing Phase II double blind, placebo controlled clinical trial investigates the safety and efficacy of the Company’s lead product, ACP-01. The Company’s patented process results in producing specific stem cells that have the ability to support the generation of new blood vessels to combat the life-threatening complications of CLI. The stem cells are raised and expanded from the patient’s blood and then re-injected into the diseased tissue. The results of the current clinical trial will lay the groundwork for an anticipated heart indication trial and ultimately commercialization. An additional indication for ACP-01 includes angina pectoris, for which the Company is planning to commence a Phase II/III trial.
“With the treatment of these first two patients in the United States, the Company has achieved a new and significant milestone that has not been done in the history of Hemostemix or the trial. We are seeing significant progress on patient and site enrollment with a goal of interim data by mid-2019. This is significant for Hemostemix as we continue to advance ACP-01 as a potentially revolutionary treatment for CLI and other diseases,” states Kyle Makofka, Chief Executive Officer and President of Hemostemix. “Having a total of four patients treated so quickly after the trial sites were on-boarded is a positive indication of the interest in our trial and the need for new treatments that could replace the need for life altering amputations.”
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, President and CEO
Suite 1049, 150 – 9th Avenue S.W.
Calgary, Alberta T2P 3H9
Phone: (403) 506-3373
E-Mail:
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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.
