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Hemostemix Announces Three Additional Sites Enrolled in Phase II Clinical Trial
CALGARY, Alberta, Oct. 09, 2018 (GLOBE NEWSWIRE) -- Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE: HEM) is pleased to announce that it has received all approvals from three 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.
Presbyterian Medical Center Novant Health Heart and Vascular Institute (“Novant”) is located in Charlotte, North Carolina with Dr. Michael Miller, MD, as the principal investigator. Dr. Miller has been practicing for over 30 years and specializes in interventional cardiology and cardiovascular disease. With 7,000 employees and over 700 physicians on medical staff, Novant is the one of the largest medical centers serving the Charlotte-Mecklenburg region. Charlotte is the largest city in North Carolina and the second largest city in the Southeastern United States. Almost 20% of its population is over the age of 55. US Census Bureau noted the number of residents across the Charlotte-Concord-Gastonia region was approximately 2.5 million as of mid-2017.
Temple University Hospital (“TUH”), which is part of the Temple University Health System (“TUHS”) is ranked among the "Best Hospitals" in the region by U.S. News & World Report. TUH is a 732-bed hospital located in Philadelphia, Pennsylvania. TUH’s Temple Heart & Vascular Institute focuses on patient-centered care, research and education with more than 100 cardiovascular caregivers. The principal investigator is Dr. Eric T. Choi, MD, who serves as the Co-Surgical Director, Temple Heart & Vascular Institute and his clinical interests include carotid artery disease and CLI. Philadelphia is the state of Pennsylvania’s largest city and one of the largest cities on the east coast of the United States. 2017 U.S. Census Bureau data shows the Philadelphia metropolitan area, which also includes Wilmington, Camden and Philadelphia suburbs, had a population of over 6 million people, ranking it as the 8th most populous metropolitan area in the entire United States.
The Tibor Rubin VA Medical Center located in Long Beach, California is one of six facilities that is part of the VA Long Beach Healthcare System (“VLBHS”) which is part of the Veterans Health Administration (“VHA”), the largest integrated health care system in the United States. Dr. Ian Gordon, MD, PhD, who specializes in vascular surgery, is the principal investigator. Dr. Gordon has over 35 years of experience as a vascular surgeon and is experienced with diabetes complications. VLBHS employs more than 2,200 full-time employees, and is the health care provider for more than 50,000 veterans.
With the addition of these three new sites, the Company has a total of nine trial sites now open for patient enrollment, which also includes Vancouver Coastal Health Research Institute (“VCHRI”) located in Vancouver, BC, University of Florida Health, located in Gainesville, Florida, Clinical Research of Central Florida, located in Winter Haven, Florida, Clinovation Research, located in Weston, Florida, Clinical Trials of Texas, Inc. located in San Antonio, Texas and Houston Methodist Hospital located in Houston, Texas. All sites are actively screening patients for enrollment in the study. In addition, the Company also has nine clinical trial sites located in Canada and the United States that are in various stages of the on-boarding process including three sites located in the states of Massachusetts, Colorado and South Carolina that have approved the Company’s clinical trial agreement pending final review board or budget approvals, which the Company expects will also be greenlighted shortly. 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.
Recently, one additional patient treatment (randomized treatment with either ACP-01 or a placebo) was performed at VCHRI, resulting in a total of 14 patients being treated under the clinical trial. To date, a total of 29 patients have been screened to assess whether they meet the enrollment criteria to be part of the Company’s clinical trial. Of these, 20 patients have been qualified to enroll or have enrolled in the clinical trial. The Company anticipates that patient enrollment will escalate rapidly with the increased momentum it is seeing on site 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 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.
“We have made significant progress on the trial recently with five key trial sites in the United States being on-boarded in the last few weeks with several others close to being greenlighted to begin patient enrollment. In addition, we have seen an enthusiastic response so far from our trial sites, as evidenced by reaching over 20% patient enrollment to-date. 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 people suffering from CLI. With the recent addition to our clinical trial team, we can further escalate our trial site onboarding and patient enrollment initiatives,” states Dr. Ravi Jain, Chief Scientific Officer 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 email@example.com.
Kyle Makofka, President and CEO
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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.