SAN DIEGO, September 28, 2017 — ViaCyte, Inc., a privately-held regenerative medicine company, today announced that the California Institute for Regenerative Medicine (CIRM) approved a grant of $20 million to support the clinical development of ViaCyte’s PEC-Direct™ product candidate. This novel cell replacement therapy is being developed as a functional cure for patients with type 1 diabetes who are at high risk for acute life-threatening complications. PEC-Direct is currently in a Phase 1/2 open-label clinical trial at multiple sites in the United States and Canada to evaluate safety and efficacy. CIRM previously provided support for the pre-clinical studies that laid the critical groundwork for the present clinical evaluation of the PEC-Direct product.
“We are grateful to CIRM and the citizens of California for their continued support of our potentially transformative stem cell-derived cell replacement therapies for diabetes,” said Paul Laikind, Ph.D., President and CEO of ViaCyte. “With PEC-Direct we intend to address a critical unmet medical need for people who are most severely impacted by type 1 diabetes. These patients are often eligible for islet transplants, a procedure that can be highly effective but suffers from a severe lack of donor material. We believe PEC-Direct could overcome some of the key limitations of islet transplant by providing a virtually unlimited supply of cells manufactured under quality-controlled conditions, a safer and more optimal route of administration, and a reduced cost.”
The PEC-Direct product candidate delivers stem cell-derived PEC-01 pancreatic progenitor cells in a device designed to allow direct vascularization of the cells, which is expected to allow for a robust engraftment and cellular performance similar to the anatomy of a normal islet. Given the open nature of the device, patients implanted with PEC-Direct, as with other transplants, will require immune suppression. Thus, it is being developed to treat patients with the greatest unmet medical need, including type 1 diabetes patients who already require immune suppression following a kidney transplant, as well as type 1 patients who are at high risk for acute complications, such as hypoglycemia unawareness, extreme glycemic lability, and/or severe hypoglycemic episodes. It is estimated that about 140,000 people in United States and Canada, or about 10% of type 1 diabetes patients, have high-risk type 1 diabetes.
“ViaCyte is focused on the development of stem cell-derived cell replacement therapies to provide a better treatment option for patients with type 1 diabetes, and we are pleased to partner with them to develop the PEC-Direct product candidate,” said Maria Millan, M.D., President and CEO of CIRM. “Developing a product to help the patients with the greatest need is well aligned with CIRM’s important mission.”
In addition to CIRM, the following institutions are also providing support for the PEC-Direct clinical trial: JDRF, CIRM’s Alpha Clinic, the Sanford Stem Cell Clinical Center, the JDRF Canadian Clinical Trials Network, the Stem Cell Network, and Alberta Innovates Health Solutions. The clinical trial is under way at the UC San Diego School of Medicine’s Altman Clinical Trials Research Institute, the University of Alberta Hospital in Edmonton, Alberta, and the University of Minnesota, with additional sites planned in the US and Canada.
For more information about ViaCyte’s clinical trials, please visit: https://clinicaltrials.gov/.
ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices. Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels. ViaCyte has two product candidates in clinical development. The PEC-Direct™ product candidate delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin. ViaCyte is headquartered in San Diego, California. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.