StemCells, a company engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery, announced that it has reached an agreement with the California Institute for Regenerative Medicine (CIRM) for CIRM to extend approximately $19.3 million in funding for 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 will be granted in the form of a forgivable loan and was awarded within CIRM's Disease Team Therapy Development Award program (RFA 10-05) in September 2012. The research is aimed towards filing an Investigational New Drug (NYSE: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 will test its HuCNS-SC cells, in a joint effort with researchers at the University of California, Irvine (NYSEARCA:UCI), as a potential treatment for Alzheimer's disease. The research team at UCI is led by the impressive pairing of 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.
Dr. Blurton-Jones delivered a presentation in July 2012 at the Alzheimer's Association Annual Meeting showing data that demonstrated the company's neural stem cells restored memory and dramatically improved synaptic function in two animal models. An important characteristic of the data is that achieving the positive results did not require a reduction in beta amyloid or tau that accumulates in the brains of Alzheimer's patients and are responsible for the pathological hallmarks of the disease.
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.
For further information, please visit stemcellsinc.com
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