VC-01™ Combination Product is in the Clinic
ViaCyte, Inc. announced in July 2014 that it had filed an 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. This first-in-human trial is evaluating the safety and efficacy of ViaCyte’s VC-01™ product candidate, a stem cell-derived, encapsulated cell replacement therapy.
VC-01’s Path to the Clinic
ViaCyte’s primary focus is on efficient delivery of a safe and efficacious product for clinical trials. The Company:
- completed preclinical safety testing, including three safety and efficacy studies performed by independent contract research organizations under good laboratory practices (GLP)
- held a successful pre-IND meeting which aligned development plans with FDA expectations
- established manufacturing processes and quality control systems for PEC-01™ cells, the Encaptra® drug delivery system, and the VC-01™ combination product candidate, which will produce sufficient product for the planned clinical studies
- submitted an IND to the FDA to initiate clinical research in patients with type 1 diabetes
- received FDA allowance of the IND and launched the first clinical site for the Phase 1/2 trial
The initial phase of clinical investigation is focusing on the safety of the VC-01 combination product in patients. Subsequent phases will focus on establishing the dose required for insulin independence. The protocol for the Phase1/2 study is approved and additional clinical protocols are under development. Investigational sites are being selected and patient enrollment has begun.
Information on the clinical testing of VC-01™ can be found at Clinicaltrials.gov.