San Diego, California, October 6, 2014 — ViaCyte, Inc., a privately-held regenerative medicine company developing a stem cell-derived islet replacement therapy for the treatment of diabetes, called VC-01™, will give two presentations at the annual Stem Cell Meeting on the Mesa Conference, being held at the Estancia La Jolla Hotel & Spa and The Salk Institute for Biological Studies, as follows:
- Paul Laikind, ViaCyte’s President and Chief Executive Officer, is scheduled to present a company update at the Partnering Forum at the Estancia on October 7, 2014, at 2:15 p.m. PST.
- Kevin D’Amour, ViaCyte’s Vice President of Research and Chief Scientific Officer, will speak at The Salk Institute on October 9, 2014, at 10:40 a.m. PST as a member of the panel discussing Clinical Trials at the Sanford Stem Cell Clinical Center.
ViaCyte announced the achievement of several business and product development milestones in the past three months, including the acceptance by the U.S. Food and Drug Administration of its Investigational New Drug application (IND) allowing the first evaluation of VC-01 in human clinical trials. These two presentations will highlight this first-in-human testing and several other recent developments.
ViaCyte’s VC-01 product candidate consists of pancreatic progenitor cells, called PEC-01™ cells, derived from a proprietary human stem cell line, encapsulated in ViaCyte’s proprietary Encaptra® device. When implanted under the skin, the PEC-01 cells are designed to mature and further differentiate into insulin-producing beta and other endocrine cells that regulate blood glucose in a manner similar or identical to the islets that normally comprise the endocrine pancreas.
Following the acceptance of its IND, ViaCyte initiated a Phase 1/2 clinical trial evaluating the VC-01 product candidate directly in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function. In addition to determining the safety of the product candidate in these patients, the study is designed to demonstrate the effectiveness of the VC-01 product candidate in replacing the lost endocrine function that is central to the disease. In an open-label, dose-escalating format, ViaCyte expects to enroll approximately 40 patients in the study at multiple clinical sites. The first clinical site participating in the trial is the Sanford Stem Cell Clinical Center at the University of California, San Diego (UCSD). The principal investigator of the trial at the UCSD site, Dr. Robert Henry, will speak alongside Dr. D’Amour at The Salk Institute on October 9, 2014.
About Type 1 Diabetes
Type 1 diabetes mellitus (previously called juvenile diabetes) is a life-threatening chronic condition in which the pancreas produces little or no insulin, a hormone needed to allow glucose to enter cells to produce energy. It is typically diagnosed during childhood or adolescence, though it can also arise in adults. Though less common than type 2 diabetes, which occurs when the body becomes resistant to insulin, type 1 diabetes affects several million Americans, according to JDRF. Currently, there is no cure for type 1 diabetes and the risk of long-term complications is high even with diligent treatment. Standard treatment involves multiple daily injections of insulin and rigorous management of diet and lifestyle.
ViaCyte is a privately-held regenerative medicine company focused on developing a novel cell therapy for the treatment of diabetes. ViaCyte’s lead product candidate, the VC-01 combination product, is based on the production of pancreatic progenitor cells derived from human pluripotent stem cells. These progenitor cells are implanted in a durable and retrievable encapsulation device. Once implanted and matured, these cells are designed to secrete insulin and other regulatory factors in response to blood glucose levels. VC-01 is being developed as a potential long-term diabetes treatment without immune suppression, and without risk of hypoglycemia or other diabetes-related complications.
ViaCyte is headquartered in San Diego, California with additional operations in Athens, Georgia. The Company is funded in part by the California Institute for Regenerative Medicine and JDRF.
Paul Laikind, Ph.D.
President and Chief Executive Officer \