ViaCyte, a private regenerative medicine drug developer, has recently announced that the U.S. Food and Drug Administration’s acceptance of a clinical trial protocol to test the company’s candidate product, VC-01, for the treatment of type 1 diabetes.
According to a ViaCyte’s press release, the company is now determined to initiate the study shortly, according to Paul Laikind, Ph.D., President and Chief Executive Officer, adding that this trial represents a “milestone for Via Cyte, as we begin studying the use of the VC-01 product candidate for the treatment of type 1 diabetes.”
This phase 1 / 2 trial will focus on the study of the safety, tolerance, and effectiveness of VC-01 in treating type 1 diabetes patients. The company estimates that the complete study will involve a total of about 40 patients who suffer from no or almost-no insulin production.
According to a ViaCyte press release, the clinical trial will seek to assess several different aspects of the experimental therapy, such as VC-01’s ability to replace lost endocrine function; the measure of insulin production through C-peptide, a biomarker for insulin; and the assessment of secondary endpoints and side effects.
VC-01 is a drug based on pancreatic progenitor cells, PEC-01TM, which are contained in a capsule that is implanted under the skin using ViaCyte’s Encaptra device and release insulin determined by blood glucose levels.
The experimental diabetes drug is expected to be a potential long-term treatment without immune suppression and without the risk of hypoglycemia.
ViaCyte believes that their now-authorized trial will be the first evaluation of a stem cell-derived replacement therapy for type 1 diabetes.