Hemostemix Announces First U.S. Patients Treated in Phase II Clinical TrialJuly 18, 2018
CALGARY, Alberta, July 18, 2018 — Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE:HEM) is pleased to announce that it has treated three additional patients including its first two patients in the United States under its continuing Phase II Clinical Trial for critical limb ischemia (“CLI”). The first two US patients were treated at Clinical Research of Central Florida located in Winter Haven in central Florida, led by the principal investigator, Dr. C. Jake Lambert, M.D. An additional patient was also recently treated at Vancouver Coastal Heath Research Institute (“VCHRI”) located in Vancouver, BC, resulting in a total of eleven patients being treated at this facility to date under the trial. As a result of these new patient treatments, we have a total of thirteen patient treatments completed at the four currently enrolled facilities to date.
As previously announced, the Company currently has four trial sites open for patient enrollment, including three trial sites in Florida and one in Canada that are all actively screening patients for enrollment in the study. The Company has approximately fifteen additional clinical trial sites located in Canada and the United States that are in various stages of the on-boarding process including eight sites that are near finalization with six of these having approved the Company’s clinical trial agreement pending final review board or budget approvals, which the Company expects will be greenlighted shortly.
The ongoing Phase II double blind, placebo controlled clinical trial investigates the safety and efficacy of the Company’s lead product, ACP-01. The Company’s patented process results in producing specific stem cells that have the ability to support the generation of new blood vessels to combat the life-threatening complications of CLI. The stem cells are raised and expanded from the patient’s blood and then re-injected into the diseased tissue. The results of the current clinical trial will lay the groundwork for an anticipated heart indication trial and ultimately commercialization. An additional indication for ACP-01 includes angina pectoris, for which the Company is planning to commence a Phase II/III trial.
“With the treatment of these first two patients in the United States, the Company has achieved a new and significant milestone that has not been done in the history of Hemostemix or the trial. We are seeing significant progress on patient and site enrollment with a goal of interim data by mid-2019. This is significant for Hemostemix as we continue to advance ACP-01 as a potentially revolutionary treatment for CLI and other diseases,” states Kyle Makofka, Chief Executive Officer and President of Hemostemix. “Having a total of four patients treated so quickly after the trial sites were on-boarded is a positive indication of the interest in our trial and the need for new treatments that could replace the need for life altering amputations.”
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