Hemostemix Announces Enrollment Update for the ACP-01 Phase II Critical Limb Ischemia Clinical Trial

CALGARY, Alberta, June 27, 2019 (GLOBE NEWSWIRE) -- Hemostemix Inc. ("Hemostemix" or the "Company") (TSX VENTURE: HEM; OTCQB: HMTXF) is pleased to announce that it has enrolled a total of forty (40) patients in its continuing Phase II Clinical Trial for critical limb ischemia ("CLI") to-date. 

As previously announced, the Company has been working closely with its trial sites over the past few months to advance patient enrollment.  In the past several weeks, seven (7) additional patients have been enrolled and treated under the Company's CLI clinical trial protocol.  This total of 40 patients that have been treated to date represent over 42% of the total trial enrollment goal.

The Company currently has fourteen (14) trial sites open, of which twelve are located in the United States and two in Canada, that are actively screening patients for enrollment in the study. The most recent trial site added is Decatur Memorial Hospital, located in Decatur, Illinois, led by principal investigator Dr. Jeffrey Trachtenberg, MD. The Company has also received IRB approval at additional clinical trial sites that will be starting up in Canada and the United States. The Company has been successful in attracting investigators that are top of their field vascular surgeons and podiatrists who are highly regarded for treating CLI patients. The Company continues to see positive interest in ACP-01 as a treatment for advanced CLI patients facing this life-threatening condition and imminent lower extremity amputations.

The clinical trial is a randomized, placebo-controlled, double blind Phase II trial of the safety and efficacy of ACP-01 in patients with advanced CLI who have exhausted all surgical and medical treatment options. Under the current USA Food and Drug Administration ("FDA") and Health Canada approved protocol, approximately 95 patients will be treated with ACP-01 and followed for twelve months. The Company's patented ACP-01 autologous stem cells have been shown in previous clinical studies to stimulate the generation of new blood vessels in CLI patients and improve amputation-free survival.  ACP-01 is derived from the patient's own blood, expanded in culture and then re-injected into the diseased tissue.

"This continued escalation in patient enrollment is a direct result of the Hemostemix internal team working closely with our clinical trial sites in support of their efforts on patient enrollment. We see the enrollment rate and the addition of new clinical trial sites as a strong indication of the importance of a treatment for these no-option critical limb ischemia patients. In addition, we are pleased to have attracted such a geographically diverse group of principal investigators experienced in the conduct of clinical research." states Dr. Alan Jacobs, Chief Medical 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 [email protected].

Contact:
Kyle Makofka, CEO
Suite 2150, 300 ? 5^th Avenue S.W.
Calgary, Alberta T2P 3C4
Phone: (403) 506-3373
E-Mail: [email protected]

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.