Health Canada has issued a No Objection Letter to ViaCyte, Inc., giving the company the go-ahead to proceed with sites in Canada for is Phase 1/2 clinical trial of VC-01 product candidate, according to a company press release.
Patients with type 1 diabetes who have minimal to no insulin-producing beta-cell function are being evaluated for the VC-01 product candidate.
“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,” Paul Laikind, PhD, preside and CEO of ViaCyte, said in a press release. “Should the product candidate proceed to the second cohort, we intend to expand the trial to multiple sites. Health Canada’s approval represents further validation of the trial and allows us to expand internationally to one or more sites in Canada.”
The FDA granted the investigational new drug application for the trial, called STEP ONE, and the study launched in September 2014 at the University of California San Diego Health System.
The trial will evaluate the effectiveness of the product candidate in replacing lost endocrine function. Forty participants are expected to be enrolled in the trial.