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$20M Grant To Fund Clinical Trial Of Type 1 Diabetes Therapy.

SAN DIEGO, Calif., September 28, 2017 -- Privately-held Via-Cyte, Inc., was awarded $20 million by the California Institute for Regenerative Medicine (CIRM) to fund clinical development of its PECDirect functional cure for patients with type 1 diabetes at high risk for acute life-threatening complications.

PEC-Direct is in a Phase 1/2 open-label clinical trial at multiple sites in the United States and Canada to evaluate safety and efficacy.

CIRM has funded preclinical studies that laid the critical groundwork for the present clinical evaluation.

The PEC-Direct product candidate delivers stem cell-derived PEC-01 pancreatic progenitor cells in a device designed to allow direct vascularization of the cells, which is expected to allow for a robust engraftment and cellular performance similar to the anatomy of a normal islet.

Given the open nature of the device, patients implanted with PEC-Direct, as with other transplants, will require immune suppression.

Thus, it is being developed to treat patients with the greatest unmet medical need, including type 1 diabetes patients who already require immune suppression following a kidney transplant.

It would also benefit type 1 patients at high risk for acute complications, such as hypoglycemia unawareness, extreme glycemic lability, and/or severe hypoglycemic episodes.

About 140,000 people in U.S. and Canada, or about 10 percent of type 1 diabetes patients, have high-risk type 1 diabetes.

Also providing support for the PEC-Direct clinical trial: JDRF, CIRM's Alpha Clinic, the Sanford Stem Cell Clinical Center, the JDRF Canadian Clinical Trials Network, the Stem Cell Network, and Alberta Innovates Health Solutions.

The clinical trial is under way at the UC San Diego School of Medicine's Altman Clinical Trials Research Institute, the University of Alberta Hospital in Edmonton, Alberta, and the University of Minnesota, with additional sites planned in the US and Canada.

The PEC-Direct product candidate delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.

The PEC-Encap (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.


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Title Annotation:In The Clinic
Publication:Stem Cell Business News
Geographic Code:1CANA
Date:Oct 2, 2017
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