HEMOSTEMIX ADDS THE 20th ACTIVE CLINICAL TRIAL SITE AND ENROLLS THE 56TH TRIAL SUBJECTJanuary 17, 2020
January 17, 2020 — Hemostemix Inc. (“HEM,” “Hemostemix” or the “Company”) (TSXV: HEM; OTC: HMTXF) announces the 20th clinical trial site is now active and the 56thtrial subject was enrolled as of December 31, 2019.
The Hemostemix Phase II study of ACP-01 is an international 20 center randomized double-blind placebo-controlled clinical trial to assess the safety and efficacy of ACP-01 injected into the lower extremity of 95 CLI patients who have exhausted all other options. A futility analysis for potentially stopping enrolment into the study will be performed when 42 subjects have completed at least 26 weeks of follow-up.
“Imagine going to your Doctor and he counsels you that he can relieve the minute by minute pain associated with the open ulcerating wounds on your feet (CLI), get you up walking again, and save your limbsfrom amputation, with a confidence factor of 83%,” said Thomas Smeenk, President. “Those are the announced results and that is how ACP-01 works to help a person who is suffering from CLI,” he said. On October 21, 2019, the Company, in conjunction with UBC, U of T, UHN and Vancouver Coastal Health released:“Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Followup” which noted “…healing of ulcers and resolution of ischemic rest pain occurred in 83% of patients, with outcomes maintained for up to 4.5 years.”Patients with critical limb ischemia (CLI) face a high risk of amputation once revascularization surgery options are exhausted. It is estimated that 160,000 amputations are carried out annually in the USA due to the failure of revascularization.
ABOUT HEMOSTEMIX INC.
Hemostemix is a publicly traded autologous stem cell therapy company, in business since 2003. A winner of the World Economic Forum Technology Pioneer Award, HEM developed, is commercializing ACP-01 and NCP-01, and has treated CLI, PAD, Angina, Ischemic Cardiomyopathy, Dilated Cardiomyopathy and other heart conditions addressed by ACP-01. HEM is the first public company to treat more than 700 patients, including 500 no-option end-stage heart disease patients, with complete safety and significant efficacy. For example, patient #35, aged 83, who at age 69 was given six months to live before his treatment November 2, 2005, celebrated his 14thpost treatment anniversary.
On October 21, 2019, the Company, in conjunction with UBC, U of T, UHN and Vancouver Coastal Health released:“Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Followup” which noted “…healing of ulcers and resolution of ischemic rest pain occurred in 83% of patients, with outcomes maintained for up to 4.5 years…”.The trial is ongoing at 20 clinical sites in North America and 56 of 95 subjects have been enrolled in it.
HEM owns 91 patents that cover the generation from peripheral blood of ACP-01 and NCP-01, the scaling of automated production, In Vitro Techniques for use with Stem Cells, a composition of matter patent – The Creation of a Progenitor Cell – and Regulating Stem Cells. For more information, please visit www.hemostemix.com.
Bryson Goodwin, CEO or Thomas Smeenk, President
Suite 1150, 707 – 7thAvenue S.W.
Calgary, Alberta T2P 3H6
BG: 604-341-1531 or TS: 905-580-4170
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 ability to fund operations and access the capital required to continue operations, the Company’s stage of development, future clinical trials and results, long-term capital requirements and 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. Additional information identifying risks and uncertainties are contained in the Company’s filing with the Canadian securities regulators, which filings are available at www.sedar.com.
View All News & Media