Hemostemix Announces Trial Site for Phase II Clinical Trial
CALGARY, Alberta, April 27, 2018 (GLOBE NEWSWIRE) -- Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE:HEM) is pleased to announce that it has entered into an agreement and has received all approvals from the Vancouver Coastal Health Research Institute (“VCHRI”) located in Vancouver, BC to be a clinical trial site for the Company’s Phase II clinical trial for critical limb ischemia (“CLI”). The Company recently announced that it received FDA approval in the United States in addition to Health Canada approval for its clinical trial in Canada.
With the engagement of Topstone Research Inc. (“Topstone”) in September 2017, the Company has been actively identifying and selecting qualified clinical trial sites in both Canada and the United States. To date, over 20 facilities and institutions have been identified as having good potential to be sites for the clinical trial. The site onboarding process is rigorous with the Company reviewing equipment, facilities, principal investigators, the estimated number of potential patients as well as putting in place agreements, budgets, procedures and protocols. In addition, the clinical trial sites have their own internal protocols for review and approval of the Company’s clinical trial protocol, agreement, overall budget and general procedures and equipment requirements.
Of the potential sites, the Company has approximately 14 clinical trial sites in various stages of the on-boarding process including 5 sites that have approved the Company’s clinical trial agreement pending final review board or budget approvals. It is anticipated that the clinical trial will be conducted at approximately 20 sites located throughout Canada and the United States.
“We are excited to announce that Vancouver Coastal Health Research Institute has agreed to be part of the clinical trial. VCHRI has a strong history of supporting research surrounding CLI and we thank Dr. Hsiang and his team for their dedication to this research. With this first trial site in place, we look forward to further sites being fully onboarded as well as patient treatment.” states Kyle Makofka, CEO and President of Hemostemix.
ABOUT VANCOUVER COASTAL HEALTH RESEARCH INSTITUTE
VCHRI is a world leader in translational health research with over 1,500 personnel engaged in research. It is the research body of Vancouver Coastal Health and a health partner of the University of British Columbia. VCHRI includes three of BC’s largest academic and teaching health sciences centers — Vancouver General Hospital, UBC Hospital and GF Strong Rehabilitation Centre — as well as other hospitals and public health agencies across Vancouver Coastal Health.
Options Approved
The Board of Directors of the Company also announced it has approved the granting of 6,300,000 options pursuant to the Company’s existing incentive stock option plan to certain directors, officers, employees and consultants of the Company. The options have an exercise price of $0.10 per common share and expire five years from the date of grant and generally have up to one-third vesting on each of the first, second and third anniversaries from the date of grant.
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 office@hemostemix.com.
Contact:
Kyle Makofka, President and CEO
Suite 1049, 150 – 9th Avenue S.W.
Calgary, Alberta T2P 3H9
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 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.