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|StemCells, Inc. Awarded CIRM Planning Grant to Pursue Preclinical Development of HuCNS-SC Cells for Alzheimer's Disease|
NEWARK, Calif., Sep 1, 2011 (GlobeNewswire via COMTEX) --
StemCells, Inc. (Nasdaq:STEM) announced today that the California Institute of Regenerative Medicine (CIRM) has approved the Company's application for a "Disease Team Therapy Development Planning Award." The grant, totaling approximately $100,000, will help fund the Company's plans to develop its proprietary human neural stem cell product, HuCNS-SC(R) cells, in Alzheimer's disease by enabling the Company and its collaborators at the University of California, Irvine, to prepare and submit an application for a "Disease Team Therapy Development Research Award." The CIRM has indicated that each Research Award will be up to $20 million, payable over four years, to fund preclinical and IND-enabling activities with the aim of starting human clinical trials within the four-year window. The CIRM has also indicated it plans to approve and fund Research Awards in the summer of 2012. StemCells, Inc. was one of only four companies awarded a disease team planning grant.
"Our research, and that of our collaborators, provides a strong rationale for developing our HuCNS-SC neural stem cells as a potential treatment for Alzheimer's disease," said Ann Tsukamoto, PhD, Executive Vice President, Research & Development of StemCells, Inc. "Our collaborator, Professor Frank LaFerla, has shown that mouse neural stem cells enhance memory in a mouse model of Alzheimer's disease, and we have previously shown that our human neural stem cells can survive in the hostile environment reflective of an Alzheimer's brain. This award is an encouraging vote of confidence, and with CIRM's help, we will be better able to pursue our aim of developing a stem cell-based therapy for Alzheimer's disease."
Dr. LaFerla's groundbreaking research was published in August 2009 in the Proceedings of the National Academy of Sciences (PNAS). Dr. LaFerla, a world renowned leader in Alzheimer's disease research, is Director of the University of California, Irvine (UCI) Institute for Memory Impairments and Neurological Disorders (UCI MIND), and Chancellor's Professor, Neurobiology and Behavior in the School of Biological Sciences at UCI. In April 2011, StemCells, Inc. and Dr. LaFerla established a research collaboration to evaluate the therapeutic potential of HuCNS-SC cells in animal models of Alzheimer's disease.
Alzheimer's disease is a progressive, fatal neurodegenerative disorder that results in loss of memory and cognitive function. Today, there is no cure or effective treatment option. According to the Alzheimer's Association, approximately 5.4 million Americans have Alzheimer's disease, including nearly half of people aged 85 and older. The prevalence of Alzheimer's disease is expected to increase rapidly as a result of our aging population.
About StemCells, Inc.
StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company's lead therapeutic product candidate, HuCNS-SC(R) cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. Clinical trials are currently underway in spinal cord injury and in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children. In addition, the Company plans to file an IND by year-end 2011 to initiate a clinical trial of HuCNS-SC cells in age-related macular degeneration, and is also pursuing preclinical studies of its HuCNS-SC cells in Alzheimer's disease and stroke. StemCells also markets stem cell research products, including media and reagents, under the SC Proven(R)brand, and is developing stem cell-based assay platforms for use in pharmaceutical research, drug discovery and drug development. Further information about StemCells is available at http://www.stemcellsinc.com.
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Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the prospect of the Company's HuCNS-SC cells to enhance memory in patients with Alzheimer's disease; the prospect of successful results from the Company's preclinical research in Alzheimer's disease; the potential of the Company's HuCNS-SC cells to treat a broad range of central nervous system disorders, including Alzheimer's disease; the prospect and timing associated with filing an IND to initiate a clinical trial in a retinal disorder; and the future business operations of the Company, including its ability to conduct clinical trials as well as its other research and product development efforts. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including the fact that additional trials will be required to demonstrate the safety and efficacy of the Company's HuCNS-SC cells for the treatment of any disease or disorder; uncertainty as to whether the FDA or other applicable regulatory agencies will permit the Company to continue clinical testing in spinal cord injury, PMD or in future clinical trials of proposed therapies for other diseases or conditions given the novel and unproven nature of the Company's technologies; uncertainties regarding the Company's ability to recruit the patients required to conduct its clinical trials or to obtain meaningful results; uncertainties regarding the Company's ability to obtain the increased capital resources needed to continue its current and planned research and development operations; uncertainty as to whether HuCNS-SC cells and any products that may be generated in the future in the Company's cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; uncertainties regarding the Company's ability to commercialize a therapeutic product and its ability to successfully compete with other products on the market; and other factors that are described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2010, and in its subsequent reports on Form 10-Q and Form 8-K.
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SOURCE: StemCells, Inc.
CONTACT: Rodney Young Chief Financial Officer (510) 456-4128