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news.US-based regenerative medicine firm ViaCyte has received a $16.6m Accelerated Development Pathway grant from the California Institute for Regenerative Medicine (CIRM) to develop a stem cell-derived islet replacement therapy called VC-01 to treat patients with type 1 diabetes.
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VC-01 has recently secured clearance from the US Food and Drug Administration (FDA) to initiate evaluation in human clinical trials.
The company’s stem cell-based therapy has been supported by several prior rounds of funding from CIRM.
The VC-01 combination product candidate includes pancreatic progenitor cells, called PEC-01 cells, derived from human stem cell line, encapsulated in the company’s Encaptra device.
When implanted under the skin, the PEC-01 cells are designed to mature and further differentiate into insulin-producing beta and other endocrine cells that regulate blood glucose similar or identical to the islets that normally include the endocrine pancreas.
ViaCyte president and CEO Dr. Paul Laikind said,"Today’s grant allows us to continue to accelerate our efforts as we move into the critically important stage of evaluating VC-01 in human clinical trials."
Recently, the FDA has accepted the company’s investigational new drug (IND) application of the VC-01 product candidate.
The funding from CIRM will help in supporting the recently started Phase I/II clinical trial in patients with type 1 diabetes, as well as additional clinical testing in the future.
The Phase I/II trial is designed to assess VC-01 directly in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function.
The VC-01 development program is also supported by JDRF, a global organization focused on type 1 diabetes research.
The trial is also designed to show the effectiveness of the VC-01 product candidate in replacing the lost endocrine function that is central to the disease.