Hemostemix Announces Enrollment Update for the ACP-01 Phase II Critical Limb Ischemia Clinical TrialJune 27, 2019
CALGARY, Alberta, June 27, 2019 — 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 bloodderived
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, CEO
Suite 2150, 300 – 5th Avenue S.W.
Calgary, Alberta T2P 3C4
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 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 forwardlooking
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.
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