PEC-Encap™ Combination Product is in the Clinic
ViaCyte, Inc. announced in July 2014 that it had filed its first Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes, and in August 2014 the IND was accepted, allowing clinical testing to commence. The first patients were implanted at UC San Diego. In 2015, ViaCyte announced the allowance of PEC-Encap clinical testing in Canada, and a second site opened in Edmonton, Alberta. The first-in-human STEP ONE* trial is evaluating the safety and efficacy of ViaCyte’s PEC-Encap (a.k.a. VC-01™) product candidate, a stem cell-derived, encapsulated cell replacement therapy. STEP ONE is the first trial in the world investigating a stem cell-derived beta cell replacement therapy for diabetes.
*Safety, Tolerability, and Efficacy of VC-01 Combination Product in Type One Diabetes
PEC-Direct™ Combination Product is in the Clinic
In 2017, ViaCyte, Inc. announced the allowance of clinical testing for its PEC-Direct cell replacement product candidate for high-risk type 1 diabetes. With the STEP ONE trial underway, and the addition of W. L. Gore & Associates as collaborators to optimize the Encaptra® cell delivery system, ViaCyte felt that the PEC-Direct approach might be the most rapid way to get the invaluable PEC-01 cell replacement therapy to those who need it most. The PEC-Direct trial is now underway in the U.S. and Canada, with clinical sites established at University of Alberta, UC San Diego, and the University of Minnesota.
The initial phase of clinical investigation is focusing on the safety of the cell replacement therapy combination products in patients. Subsequent phases will focus on establishing the doses required for efficacy, or reduction or elimination of insulin use. The protocols for the Phase1/2 studies of PEC-Encap and PEC-Direct are approved and additional clinical protocols are under development. Investigational sites are being selected and patient enrollment has begun.
Information on the clinical testing of ViaCyte’s implantable cell replacement therapies can be found at Clinicaltrials.gov.