Developing PEC-Direct to address urgent medical need in patients with high-risk type 1 diabetes
SAN DIEGO, September 21, 2017 – Today, ViaCyte announced that its PEC-Direct™ product candidate has been selected as one of three finalists for CONNECT’s Most Innovative New Product Awards in the Life Science Product, Clinical Stage, category. CONNECT, a premier innovation company accelerator in San Diego that creates and scales great companies in the technology and life sciences sectors, continues its thirty-year tradition of celebrating innovation leaders in the San Diego community.
“As a company with deep ties to the San Diego community, we are honored to have PEC-Direct recognized as a finalist for CONNECT’s Most Innovative New Product Awards,” said Paul Laikind, PhD, President and Chief Executive Officer of ViaCyte. “Patients with high-risk type 1 diabetes complications, such as hypoglycemia unawareness, are at constant risk of life-threatening low blood glucose. ViaCyte is developing PEC-Direct to address this most urgent medical need and provide these patients with a potentially life-saving therapy.”
The PEC-Direct product candidate is being developed for patients with high-risk type 1 diabetes, who often experience life-threatening acute complications, such as hypoglycemia unawareness and severe hypoglycemic episodes. PEC-Direct could also be important for patients that have undergone a kidney transplant as a result of diabetic complications. 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, would require chronic immune suppression. After implantation, the cells are expected to mature into the full complement of islet cells, including insulin-producing beta cells, offering a potential functional cure for patients with high-risk type 1 diabetes.
“At ViaCyte, our mission is to profoundly improve the lives of people with type 1 diabetes. To accomplish that, we have become leaders and pioneers in many areas, breaking new ground in stem cell research and medical device engineering, and developing brand new methods of cell therapy scaling and manufacturing,” said Dr. Laikind. “ViaCyte’s innovative cell replacement therapy has received support from well-respected organizations, including CIRM and JDRF, and represents a potentially transformative new life-saving approach that could help hundreds of thousands of people with high-risk type 1 diabetes around the world.”
For more than a decade, ViaCyte has been developing innovative stem cell-derived cell replacement therapies with a focus on the treatment of insulin-requiring diabetes. The company was the first to describe directed differentiation of human pluripotent stem cells into pancreatic cells, and the first to demonstrate the differentiation of stem cell-derived pancreatic progenitor cells into glucose-responsive insulin-producing cells, both in vivo and in vitro. In addition, ViaCyte launched the first clinical trials for stem cell-derived islet replacement therapies for type 1 diabetes. PEC-Direct is currently being evaluated in a Phase 1/2 clinical trial at the UC San Diego School of Medicine’s Altman Clinical Trials Research Institute and other sites in the United States and Canada. It is estimated that about 140,000 people in United States and Canada have high-risk type 1 diabetes.
The 2017 Most Innovative New Product Awards presentation and dinner will be held on the evening of November 30 at Hyatt Regency La Jolla at Aventine, 3777 La Jolla Village Drive, San Diego, CA 92122. Each of the finalists will be featured in the Innovation Showcase and the winner in each of ten categories will be announced live during the dinner.
For a complete list of finalists and additional information, please visit the Most Innovative New Product Awards Website.
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 products 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.
CONNECT is a premier innovation company accelerator in San Diego that creates and scales great companies in the technology and life sciences sectors. By creating an environment in which entrepreneurs and C-suite executives have access to the people, capital, and technology resources they need for success, CONNECT has assisted in the formation and development of more than 3,000 companies since 1985. Widely regarded as one of the world’s most successful organizations linking entrepreneurs and C-suite executives with the resources they need for the commercialization of innovative products and services; our program has been modeled in more than 50 regions around the world. www.connect.org