CALGARY, Alberta, Feb. 25, 2019 (GLOBE NEWSWIRE) -- Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE: HEM; OTCQB:HMTXF) is pleased to announce that it has received all approvals from UC Davis Health (“UC Davis”) located in Sacramento, California to be the clinical trial site for the Company’s Phase II clinical trial for critical limb ischemia (“CLI”).
UC Davis Medical Center brings state-of-the-art vascular care to patients throughout Central and Northern California. The Division of Vascular Surgery at UC Davis Medical Center has grown to become the largest vascular specialty group in the region. The division is committed to supporting UC Davis Medical Center in its emerging role as a nationally-recognized tertiary care referral center, providing state-of-the-art care for patients with all types of vascular diseases. Clinical and basic science research is one of the core elements of the division. Dr. Matthew W. Mell, M.D, M.S. is the principal investigator for the trial at UC Davis. Dr. Mell specializes in vascular surgery and is the Medical Director of the Vascular Center at UC Davis. He is also a professor and the Chief of Vascular Surgery. Dr. Mell specializes in complex vascular and endovascular surgery, is a well-regarded expert in health policy, and is nationally recognized for his work in aneurysm screening, surveillance, and improving systems of care for treating ruptured abdominal aortic aneurysms.
With the addition of UC Davis, the Company has a total of twelve trial sites now open for patient enrollment, of which eleven are located in the United States and one in Vancouver, Canada. All sites are actively screening patients for enrollment in the study. In addition, the Company also has several clinical trial sites located in Canada and the United States that are in various stages of the on-boarding process. The Company specifically targets strategic clinical sites throughout the United States and Canada that serve large populations or have the demographics to support patient enrollment.
The clinical trial is a randomized, placebo-controlled, double blind Phase II clinical trial to confirm the safety and efficacy of ACP-01. Under the current USA Food and Drug Administration (“FDA”) and Health Canada approved protocol approximately 95 patients will be followed for a minimum period of six months and a maximum of twelve months. The Company’s patented process results in 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 differentiated and expanded from the patient’s blood and then re-injected into the diseased tissue.
“The addition of UC Davis Health as our second site in the state of California represents another key trial site for the Company and we are very pleased to have them on board with their Chief of Vascular Surgery as their principal investigator. We feel being able to attract another well-recognized facility is a positive indication about our clinical trial and ACP-01 as a potential treatment for CLI,” states Kyle Makofka, President and CEO of Hemostemix.
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 one of the first clinical-stage biotech companies 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.
For more information, please visit www.hemostemix.com or email office@hemostemix.com.
Contact:
Kyle Makofka, President and CEO
Suite 2150, 300-5th Avenue S.W.
Calgary, Alberta T2P 3C4
Phone: (403) 506-3373
E-Mail: kmakofka@hemostemix.com
Neither the TSX Venture Exchange 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. 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 trials and 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.