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Hemostemix Announces Addition to Its Clinical Trial Management Team
CALGARY, Alberta, Sept. 24, 2018 (GLOBE NEWSWIRE) -- Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE: HEM) is pleased to announce that Catherine St. George has joined the Company as a Clinical Trial Manager.
Ms. St. George has over 20 years of clinical research experience in phase II and III drug and device trials. She has played a key management role for numerous multi-site clinical trials across the United States and Canada spanning multiple therapeutic disciplines. Catherine’s career includes working at companies in the pharmaceutical and biotech industries, contract research organizations (“CRO”s) and academic sites, including Pfizer Canada and the University of Calgary. Her management expertise extends to the regulatory, ethical, patient recruitment and financial processes necessary to execute successful clinical trials. Her career began at the University of Calgary in basic research laboratories in 1984 and transitioned to clinical research in 1996 when she started coordinating multi-centre clinical trials.
Catherine graduated from St. Francis Xavier University, Antigonish, Nova Scotia in 1982 with a Bachelor of Science degree. In 2006, she received her Certified Clinical Research Professional (“CCRP”) designation.
Hemostemix is building its senior clinical trial team with the addition of Ms. St. George. This experienced team includes Christy Pifer, BSc, CCRP as clinical trial manager and is led by Dr. Ravi Jain, PhD. Dr. Jain has over 16 years of progressive scientific, R&D and management expertise. Dr. Jain has a Bachelor of Science degree in Genetics from the University of California, Davis, was awarded the Regents’ Scholarship and President’s Undergraduate Research Fellowship and obtained his PhD in Molecular Evolution from the University of California, Los Angeles, and was awarded NIH fellowships in Genetic Mechanisms and Bioinformatics. Ms. Pifer has over 18 years of clinical research experience in phase I, II and III drug trials and has coordinated over 100 phase I, II and III clinical trials over the past 12 years in the areas of cardiology, pulmonary medicine and vascular disease. She spent 11 years at the Vascular Center at the University of California, Davis in Sacramento, CA, managing all peripheral vascular trials, including critical limb ischemia (“CLI”) and cell therapy trials.
In addition to managing the current Phase II clinical trial for CLI with a focus on site and patient recruitment, both Ms. Pifer and Ms. St. George will work with Dr. Jain on the Company’s next United States Food and Drug Administration's pre-Investigational New Drug (“pre-IND”) submission for a clinical trial for a heart indication. The Company previously completed two Phase I trials and one Phase II trial for two heart indications, all of which focussed on confirming safety.
The current clinical trial for CLI 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. Currently, the Company has 18 trial sites located throughout Canada and the United States that are either fully engaged or in various stages of site approval process with 6 of these sites fully approved and open to patient enrollment. The Company continues to see a positive response from these sites for patient recruitment, screening and enrollment as it actively works toward reaching patient and trial site goals.
“We are extremely pleased to have someone with Catherine’s extensive clinical trial expertise join our team. Her expertise with multi-site trials, patient enrollment and working with the FDA will be valuable not only for our current CLI trial, but also as we progress with our future clinical trial plans. It is important to note that the current CLI trial is the largest US FDA and Health Canada Phase II trial being pursued from our technology platform to-date and the Company is working towards preparing for other clinical trials based on ACP-01 and the platform we have developed. The Company is currently compiling data and reviewing information with the goal of submitting a pre-IND submission with the FDA for a heart indication before the end of the 4th quarter for 2018.” states Kyle Makofka, Chief Executive Officer and President 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 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.
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
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.
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.