Hemostemix to combine ACP-01 with Dr. James Shapiro’s Islet Cells to treat Type 1 Diabetes
Professor James Shapiro led the clinical team with the “Edmonton Protocol” islet transplant success, and was lead author of the 2000 New England Journal of Medicine (“NEJM”) study. He was the principal investigator of an international trial that replicated the Edmonton protocol study success, which was published in the NEJM in 2006. As principal investigator on several international islet transplant trial grants, Dr. Shapiro has brought in more than $85 million in grant and philanthropic support through the U of A for work on islet transplantation. He has been the recipient of multiple awards, including the Hunterian Medal from the Royal College of Surgeons of England, the Gold Medal in Surgery from the Governor General of Canada, Physician of the Century, and was named one of Nature Biotechnology’s most remarkable and influential personalities. He was elected Fellow of the Royal Society of Canada in 2012, and was recently appointed as the Department of Surgery’s first Canada Research Council’s Chair in Transplantation Surgery and Regenerative Medicine.
Professor Shapiro is a busy clinical hepatobiliary and pancreatic oncology and transplant surgeon, and also maintains an active immunology/transplant research laboratory. His group is actively researching personalized medicine approaches to pancreatic and other hepatobiliary cancers, with generation of human tumor transplantation in immunodeficient mouse models, using a novel pre-vascularized subcutaneous implantation site model.
“I am particularly excited about the potential of ACP-01 to improve early engraftment, survival and function of transplanted human islets and stem cell products, and we are poised to explore this potential,” said Dr. Shapiro. “We believe that improving cell survival is key to improving short-term and long-term cell transplant function in our diabetes trials, as we look ahead to future cell therapy treatments that could one day reverse diabetes in the 450 million suffers worldwide” he said.
“In facilitating islet cell survival and mitigating local inflammation and autoimmunity, angiogenic cell precursor (ACP) technology will help to surmount two major obstacles to more widespread adoption of islet cell transplantation for treatment of type 1 diabetes, said Dr. Fraser Henderson, CMO. In addition, we anticipate salutary effects of ACP upon microvasculature in general and renal function in particular,” he said.
“This is the first of many such new developments Hemostemix will introduce to the market in 2022. In part, this demonstrates the hidden value of Hemostemix as a stem cell platform technology company,” said Thomas Smeenk, CEO.
ABOUT HEMOSTEMIX
Hemostemix is a publicly traded autologous stem cell therapy company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company developed and has published seven peer reviewed articles about the safety and efficacy of its lead product ACP-01 for the treatment of CLI, PAD, Angina, Ischemic Cardiomyopathy and Dilated Cardiomyopathy. ACP-01 has been used to treat over 300 patients. ACP-01 is the subject of a randomized, placebo-controlled, double blind trial of its safety and efficacy in patients with advanced critical limb ischemia who have exhausted all other options to save their limb from amputation.
On October 21, 2019, the Company announced the results from its Phase II CLI trial abstract presentation entitled “Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Follow-up” which noted healing of ulcers and resolution of ischemic rest pain occurred in 83% of patients, with outcomes maintained for up to 4.5 years.
The Company owns 91 patents across five patent families titled: Regulating Stem Cells, In Vitro Techniques for use with Stem Cells, Production from Blood of Cells of Neural Lineage, and Automated Cell Therapy.