JDRF announces funding of $7 million to help ensure a rapid transition of ViaCyte’s VC-01 encapsulated cell therapy product into the clinical phase of development.
The clinical phase testing will begin once ViaCyte’s investigational new drug (IND) therapy is accepted by the FDA.
ViaCyte’s VC-01 product candidate is a cell replacement therapy that could transform the way individuals with type 1 diabetes manage their disease by supplying an alternative source of insulin-producing cells with the potential to free individuals from a dependence on external insulin use. The product candidate uses pancreatic progenitor cells derived from a stem cell line which are encapsulated inside a semi-permeable drug delivery system. The product is designed to be inserted under the skin where, after maturation of the stem cells into islet-like structures including beta cells, they are expected to produce insulin and other pancreatic hormones in response to blood glucose levels, similar in manner to that of normal islets in the pancreas. If the product candidate performs as intended, it has the potential to provide individuals who have type 1 diabetes with a replacement for the beta cells lost or impaired as a result of their disease.
JDRF views beta cell encapsulation research as an area of extreme promise and priority. They began their partnership with ViaCyte in December 2011 and previously provided the company with $6 million in funding that has contributed to the progress in developing the VC-01 product.
In order to initiate the clinical evaluation of the VC-01 product, ViaCyte is planning on filing an IND with the FDA within the next quarter. The company also plans to begin testing on patients with type 1 diabetes around mid-year provided there are no objections from the FDA. The purpose of these human studies is to evaluate efficacy and safety.
Jeffrey Brewer, President and CEO of JDRF, said, ”ViaCyte has an innovative and advanced technology that we believe has the potential to significantly benefit people with type 1 diabetes. A product like VC-01 could someday be a key step in helping JDRF achieve its vision of creating a world without type 1 diabetes.”
Practice Pearls:
JDRF is funding $7 million to the development of ViaCyte’s promising new type 1 diabetes encapsulated cell therapy (VC-01).
VC-01 works by providing patients with an alternative source of insulin-producing cells and could free them from insulin dependence.
The IND for VC-01 and human studies aimed to detect safety and efficacy are scheduled to start in the near future.
”JDRF to Provide Additional Support for Upcoming Clinical Trial of ViaCyte’s Encapsulated Cell Therapy for Type 1 Diabetes.” JDRF to Provide Additional Support for Upcoming Clinical Trial. ViaCyte, n.d. Web. 09 Feb. 2014.
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