ORLANDO, Florida, July 6, 2020 – Aspire Health Science, LLC (the “Company” or “Aspire”), an FDA registered cGMP manufacturing facility specialized in the research, development, and manufacturing of cell-based therapies.
Through a licencing agreement with Hemostemix Inc. (“Hemostemix”), Aspire is responsible for manufacturing and managing clinical trial activities including patient data collections and processing of ACP-01 cell therapy for the indication of Critical Limb Ischemia (“CLI”). The Phase 2 clinical trial for CLI reached its Midpoint in April 2020, with 65 subjects treated and 42 patients having completed 6-month follow ups. A data set was prepared and delivered to Accudata Solutions, Inc. (“Accudata”), a third-party biostatistician, for statistical analysis and a summary report of the results were prepared (the “Midpoint Statistical Analysis”). This report has been delivered to Hemostemix as requested.
The decision to conduct an interim analysis should be based on sound scientific reasoning that is guided by clinical and statistical integrity, standard operating practices for interim analyses, and regulatory concerns. Such a decision must not be based on natural tendencies toward operational curiosity or promotional goals. A lack of scientific discipline and standardized review processes related to interim analyses can flaw and ultimately compromise the results of a properly executed clinical trial.
Under protest by Aspire, the Midpoint Statistical Analysis has been released to both Aspire and Hemostemix for review.
Initial Summary for ACP-01 CLI Clinical Trial:
As part of the Midpoint Statistical Analysis, Accudata indicated:
“As far as efficacy, at this stage of the clinical trial, there is not enough evidence to demonstrate that there is a difference between the two treatment groups in either the incidence or the timing of primary endpoint events.”
“The lack of a finding in the primary endpoint is supported by the apparent lack of a treatment difference on subjective measures of pain in the treated limb and total ulcer size. Reductions in sizes of existing ulcers would have been offset by appearance of new ulcers. “ Aspire does not support or endorse the claims Hemostemix has publicly made regarding the clinical trial in recent press releases and marketing materials. Additionally, data collected from the clinical trials outside of Health Canada and US FDA regulatory oversite has not been reviewed by Aspire or Accudata and is not within scope of the Midpoint Statistical Analysis. Aspire’s current understanding of ACP-01, clinical trial protocols, manufacturing protocols, and the Midpoint Statistical Analysis has not been considered or utilized in the interpretation or publication of results by Hemostemix. Aspire is not comfortable with past claims by Hemostemix regarding the current status and efficacy of ACP-01 and question the capability, established procedures, and credentials of those charged with the task of accurately and effectively interpreting and publishing results on behalf of Hemostemix.
For these reasons, Aspire will be discontinuing any further research and development of the ACP-01
platform until further independent reviews are properly completed.
Aspire maintains its position as the rightful licensee of the ACP-01 product and will be monitoring Hemostemix’s activities, as inappropriate action may have a negative impact on the integrity of the trial data and potential to commercialize the product in a timely manner through the proper research and regulatory channels.
ABOUT ASPIRE HEALTH SCIENCE, LLC
Aspire Health Science, LLC is an FDA registered manufacturing facility specialized in development and manufacturing of cell-based therapies.
Kyle Makofka, CEO
Aspire Health Science, LLC
Tel: (407) 420-7246