SAN DIEGO, Jan. 8, 2015 /PRNewswire/ -- ViaCyte, Inc., a privately-held regenerative medicine company with the first stem cell-derived islet replacement therapy for the treatment of diabetes in clinical trials, has received a No Objection Letter from Health Canada providing clearance to proceed with sites in Canada for the Company's Phase 1/2 clinical trial of its VC-01TM product candidate. The VC-01 product candidate is currently being evaluated in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function. The location and enrollment start date of the first Canadian clinical trial site have not yet been disclosed.
"The first cohort of patients in this two-cohort dose escalation study of the VC-01 product candidate is currently being assessed at a single site in the United States. Should the product candidate proceed to the second cohort, we intend to expand the trial to multiple sites," said Paul Laikind, PhD, President and CEO of ViaCyte. "Health Canada's approval represents further validation of the trial and allows us to expand internationally to one or more sites in Canada."
The Investigational New Drug application for the Phase 1/2 trial, called STEP ONE, or Safety, Tolerability, and Efficacy of VC-01 Combination Product in Type 1, was allowed by the US Food and Drug Administration in August 2014. The STEP ONE trial was launched in September 2014 at UC San Diego Health System, with the support of the UC San Diego Sanford Stem Cell Clinical Center and under the direction of Principal Investigator Robert Henry, MD. The first implant was performed in October 2014.
In addition to determining the safety of the product candidate in these patients, STEP ONE is designed to evaluate 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.
ViaCyte is a privately-held, clinical-stage regenerative medicine company focused on developing a novel cell therapy for the treatment of diabetes. ViaCyte is conducting a Phase 1/2 clinical trial, called STEP ONE, of the Company's lead product candidate VC-01 in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function. The VC-01 combination product is based on the production of pancreatic progenitor cells (PEC-01™ cells), which are implanted in a durable and retrievable encapsulation device, known as the Encaptra® drug delivery system. Once implanted and matured, these cells are designed to secrete insulin and other regulatory factors in response to blood glucose levels. The VC-01 combination product 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. For more information, please visit www.viacyte.com.