Hemostemix Announces Two Additional Sites Enrolled in Phase II Clinical Trial
CALGARY, Alberta, Jan. 03, 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 two new medical centers to be clinical trial sites for the Company’s Phase II clinical trial for critical limb ischemia (“CLI”). In addition, the Company is pleased to provide an update on patient enrollment in the trial.
Medical University of South Carolina is located in Charleston, South Carolina, USA with Dr. Thomas E. Brothers, MD as the principal investigator. Dr. Brothers is a vascular surgeon who focuses on management of circulation and peripheral vascular disease and has been recognized as one of America’s top surgeons and best doctors since 2003. Founded in 1824, the Medical University of South Carolina (“MUSC”) educates and trains more than 3,000 students and 700 residents in six colleges and has nearly 13,000 employees, including approximately 1,500 faculty members. MUSC operates a 700-bed medical center, which includes a nationally recognized children’s hospital, the NCI-designated Hollings Cancer Center, a Level I trauma centre and South Carolina’s only transplant center.
Moses H. Cone Memorial Hospital (“MCMH”) is located in Greensboro, North Carolina, USA with Dr. Vance Wells Brabham IV, MD as principal investigator. Dr. Brabham is a board-certified surgeon who specializes in vascular surgery. His professional interests include complex aortic repair, carotid disease, minimally invasive and surgical treatment of peripheral vascular disease, and venous disease. MCMH is the largest and most comprehensive medical center within its five-county region with a 63-acre campus including a 536-bed teaching hospital and referral center. One of its featured services is the Cone Health Heart Vascular Center. The MCMH has been recognized for heart and vascular care and focuses on clinical trials that have high potential for advancing treatment of heart and vascular disease.
With the addition of these two new sites, the Company has a total of eleven trial sites now open for patient enrollment, of which ten 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 seven 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.
Currently a total of twenty four (24) patients have been treated under the clinical trial to-date. The Company anticipates that patient enrollment will escalate rapidly with these additional trial sites on-boarded.
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.
“We are excited with the progress we have made on the trial with these two key trial sites located in North and South Carolina being recently on-boarded. Both of these sites have recognized heart and vascular centers with leading vascular surgeons acting as principal investigators. The escalation in site enrollment is a positive indication of the interest in our trial and the need for new treatments for CLI that could offer an alternative to life altering amputations which is currently one of the limited treatment options available for some CLI sufferers,” 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 firstname.lastname@example.org.
Kyle Makofka, President and CEO
Suite 1049, 150 – 9th Avenue S.W.
Calgary, Alberta T2P 3H9
Phone: (403) 506-3373
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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.