ACP-01 Phase II Clinical Trial for CLI

ACP-01 Phase II Clinical Trial

ACP-01 has completed a randomized, double-blind placebo-controlled Phase II clinical trial for CLI. In the 17 center Phase II clinical trial, 68 subjects were randomized 2:1 to receive ACP.

The trial demonstrated that ACP-01 was safe. Treated patients, as compared to placebo treated patients:

trended toward improvements in ulcer healing at 3 months
trended toward ulcer healing at 6 months
trended toward ulcer healing at the end of study at 12 months
and, trended toward a reduction in pain associated with critical limb ischemia at 12 months, the end of the study.

As originally designed, the clinical trial power analysis required 95 subjects to achieve a statistically significant result. The previous management team, however, truncated the trial to 65 subjects, reducing to 25% the power for the analysis of the study’s primary endpoint.

The clinical trial data was generated from patients treated at 17 participating sites across North America. Of 107 patients screened for the clinical trial, 68 were randomized to receive either ACP-01 (n=47) or placebo (n=21). Of the patients treated with ACP-01, 27 completed the study, and 20 withdrew. Of those treated with placebo, 19 completed the study and 2 withdrew. The data was entered into a database hosted by Medrio and the company completed verification of 71% of data points using source documents held at each site. Patient follow-up ranged from 1 day to 401 days since treatment. The median time to event was 241 days.

The annual incidence of CLI is estimated to be 220-3,500 per 1,000,000 and its prevalence is estimated to be 1% of the adult population (CLI epidemiology and clinical presentation). It is estimated there are 236 Million who suffer from peripheral arterial disease (PAD), and up to 10% of PAD patients progress to CLI (23,600,000). Hemostemix is scaling its patented automated cell therapy system (“ACTS Production) to 4,000 batches per month by the end of 2027 to optimize its costs and margins while completing its clinical trials. Thereafter, ACTS production pods may be located in centralized production plants that scale to meet demand.

2:1 to receive ACP