July 17, 2014
San Francisco, CA – A promising treatment for type 1 diabetes that has received almost $40 million in funding from the stem cell agency, the California Institute for Regenerative Medicine (CIRM), has taken a major step towards being tested in people.
ViaCyte Inc., the company behind the therapy, has submitted an Investigational New Drug application (IND) with the Food and Drug Administration (FDA) seeking permission to start a phase 1/2 clinical trial in patients with type 1 diabetes (T1D). The trial is designed to see if their implantable product, the VC-01™ product candidate, is safe and shows evidence of being efficacious for patients with the disease.
Viacyte’s approach uses a thin plastic pouch, containing an immature form of pancreatic cells that, when implanted under the skin, are designed to mature and become insulin-producing and other cells needed to regulate blood glucose levels. These cells are able to sense when blood glucose is high, and then secrete insulin to restore it to a healthy level. In effect this is designed to mimic the glucose regulating functions of the pancreas, which, in people with T1D, no longer works. This approach was shown to be effective in extensive preclinical testing in models of the disease.
“This is good news for ViaCyte and is a clear sign of the progress they are making.” says C. Randal Mills, Ph.D., the President and CEO of the stem cell agency. “Filing for an IND is a crucial step along the path to bringing a stem cell treatment to patients. CIRM will be working with them and supporting them every step of the way to try and make this happen as quickly, and as safely, as possible.”
The complete press release can be read here