11:15:31 EDT Thu 02 May 2024
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Hemostemix releases clinical results via Biomedical

2024-02-06 14:15 ET - News Release

Mr. Thomas Smeenk reports

HEMOSTEMIX ANNOUNCES UPDATED PHASE II RANDOMIZED CLINICAL TRIAL RESULTS PUBLISHED BY THE JOURNAL OF BIOMEDICAL RESEARCH AND ENVIRONMENTAL SCIENCES

The Journal of Biomedical Research and Environmental Sciences has published Hemostemix Inc.'s phase II randomized clinical trial results.

The publication highlights the results of no option critical limb ischemia patients who started the clinical trial with an ulcer, comparing wound healing, amputation and mortality between the patients treated with ACP-01 and patients treated with a placebo, and stated the following:

  • Sixty-seven patients with no option critical limb ischemia were allocated to treatment with ACP-01 (46/67) or placebo (21/67).
  • From these data, only patients who presented with wound ulcers before administration of ACP-01 were reviewed (21 treatment, eight placebo).
  • Ulcer size in the treated group decreased from a mean of 1.46 square centimetres to 0.48 square millimetre (p equals 0.01) by three months. There was no significant decrease in the size of the ulcers of the placebo group (p less than 0.54).
  • At one year there were no complications related to treatment.
  • The treatment group had one amputation (4.8 per cent) and one death (4.8 per cent).
  • The placebo group had two amputations (25 per cent) and one death (12.5 per cent).

"In evaluating the subgroup of patients who presented with ulcerous wounds, there was a significant decrease in ulcer size at three months, lower amputation rate at 12 months, and a lower mortality rate at 12 months in the ACP-01 treatment group. Moreover, the one-year death rate in the patients treated with ACP-01 for CLI (4.8 per cent) was substantially less than the death rate reported in the literature of 15 per cent to 20 per cent within six months of a CLI diagnosis. Similarly, the amputation rate of 4.8 per cent in this treatment subgrouop compares favourably with the literature, the latter variably reporting amputation rates of 10 per cent to 40 per cent per year.," stated Dr. Fraser Henderson, chief medical officer.

"I want to thank the authors for their scientific contributions, and bringing this clinical data to fruition. The growing body of evidence in eight peer reviewed publications covering 318 subjects suggests that ACP-01 is safe and efficacious in the treatment of various forms of ischemia," stated Thomas Smeenk, chief executive officer. "We will have additional news of the production of ACP-01 for revenue and clinical trials in the near future, as we are selling ACP-01 as treatment for CLI under exemption," Mr. Smeenk said.

About Hemostemix Inc.

Hemostemix is an autologous stem cell therapy company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the company has developed, patented and is scaling a patient's blood-based stem cell therapeutics platform that includes angiogenic cell precursors, neuronal cell precursor and cardiomyocyte cell precursors.

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