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NEWARK, Calif., April 11, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM) today announced that it has entered into an agreement with the California Institute for Regenerative Medicine (CIRM) under which CIRM will provide approximately $19.3 million to help fund preclinical development and IND-enabling activities of the Company's proprietary HuCNS-SC® product candidate (purified human neural stem cells) for Alzheimer's disease. The funding, which will be in the form of a forgivable loan, was awarded under CIRM's Disease Team Therapy Development Award program (RFA 10-05) in September 2012. The goal of the research will be to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration within four years.
"With CIRM's support, we are now able to lay the groundwork that could result in the world's first neural stem cell trial in Alzheimer's patients," commented Martin McGlynn, President and CEO of StemCells, Inc. "Currently, there are no good treatment options for Alzheimer's patients, and there aren't any on the horizon, so it is clear that the field could benefit from creative approaches to this devastating and challenging disease. Our collaborators at UC Irvine have provided a compelling preclinical rationale to test the utility of our cells to restore memory in patients afflicted with this deadly condition."
StemCells, Inc. will evaluate its HuCNS-SC cells as a potential therapeutic in Alzheimer's disease in collaboration with researchers at the University of California, Irvine (UCI) led by Frank LaFerla, Ph.D., a world-renowned researcher in the field, and Matthew Blurton-Jones, Ph.D. Dr. LaFerla is Director of the Institute for Memory Impairments and Neurological Disorders (UCI MIND), and Chancellor's Professor, Neurobiology and Behavior. Dr. Blurton-Jones is Assistant Professor, Neurobiology and Behavior, at UCI.
In July 2012, Dr. Blurton-Jones presented data at the
Alzheimer's Association Annual Meeting demonstrating that the Company's neural stem cells restored memory and significantly enhanced synaptic function in two animal models relevant to Alzheimer's disease. Importantly, these results did not require reduction in beta amyloid or tau that accumulates in the brains of patients with Alzheimer's disease and account for the pathological hallmarks of the disease.
Terms and Conditions of the Loan
Loan funds are expected to be disbursed periodically over the four-year project period, with disbursements subject to a number of preconditions, including the achievement of certain progress milestones and compliance with certain financial covenants. The term of the loan is ten years, but may be extended under certain circumstances. The loan is unsecured and will bear interest at the one year LIBOR rate plus two percent; however, the interest rate will increase by one percent each year after year five. The loan is forgivable, such that the Company's obligation to repay the loan will be contingent upon the success of HuCNS-SC cells in Alzheimer's disease. No warrants will be issued in connection with the loan, but the Company will owe various success milestone payments in the event of the product's commercial success.