San Francisco, CA – The California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, today awarded $16 million to help accelerate the development of a treatment for type 1 diabetes.
The award is part of the Accelerated Development Pathway program. The goal of the program is to provide researchers who already have funding from the agency to move their work towards a clinical trial; the extra funding is to enable them to do additional work that will accelerate the development of their therapy.
“Our mission is to accelerate the development of effective treatments that target unmet medical needs in patients,” says C. Randal Mills, Ph.D., President and CEO of the agency. “The Accelerated Development Pathway does just that, building on existing funding for a project to help the investigators do additional work to advance their research and hopefully speed up their progress.”
ViaCyte Inc. was given $16 million to advance its work in type 1 diabetes. The company has already received approval from the Food and Drug Administration (FDA) to begin clinical trials of its product candidate, a thin plastic pouch that contains an immature form of pancreatic cells. When the device is implanted under the skin the cells are able to sense when blood sugar is high and, in response, secrete insulin to restore it to a healthy level.
“As projects like these advance it is often important for researchers to do additional studies, ones that were not anticipated when they first applied for funding,” says Jonathan Thomas, Ph.D., J.D., Chair of the agency’s Board. “A lack of funding could slow down the research. We want to do everything we can to help promising projects stay on track to help people in need.”
The new funding will enable ViaCyte to do additional functional studies on the device, and to follow patients for three years after the study ends. It will also support them in developing a larger capacity version of the device, to enable them to use more cells, and to do the studies needed to enable it to be used in patients. The initial site for this first-in-human testing of an implanted cell therapy will be at the University of California, San Diego Health System and is supported by the UC San Diego Sanford Stem Cell Clinical Center.
Mills also unveiled his plans to launch CIRM 2.0, giving the agency a new focus on the best ways to achieve its mission, and new tools to enable it to do that. As part of that new focus he told the Board about a proposal to speed up the agency’s funding process, to enable it to more nimbly respond to the needs of researchers with projects ready to go to clinical trials. The first phase of CIRM 2.0 is expected to be launched January 1, 2015.
The Board also approved a proposal designed to reduce perception of an inadvertent conflict of interest among CIRM employees who may be considering taking a job with an institution or company that receives CIRM funds. The proposal acknowledges that because the agency has recruited such high caliber individuals it is always a possibility that companies or institutions would try to hire them away.
The new policy will require employees to contact the agency’s General Counsel if they have begun discussions with a “prospective employer that has received or is currently applying for CIRM funding.” The information will remain confidential but it will enable General Counsel to advise the employee of their obligations under state law.
“We have an extraordinary group of people working at CIRM,” says Mills. They are smart, committed, passionate and experienced and we know others will try to recruit them. This policy establishes a procedure to ensure there is not even a perception of a conflict of interest as a result of that action, regardless of whether or not the person is offered or accepts the position. It is our responsibility to work proactively to continually earn the trust the public has placed in us.”
About CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research.