Company Has Received First Disbursement of $3.8 Million
NEWARK, Calif., July 30, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM) today announced that it has formally launched its Alzheimer's disease program, which is being supported by the California Institute for Regenerative Medicine (CIRM). The goal of the project is to file, within four years, an Investigational New Drug (IND) application with the U.S. Food and Drug Administration to evaluate the Company's proprietary HuCNS-SC® product candidate (purified human neural stem cells) as a potential therapeutic in the treatment of Alzheimer's disease. CIRM has agreed to provide approximately $19.3 million to the Company in the form of a forgivable loan to help fund preclinical development and IND-enabling activities, and the Company recently received an initial disbursement of $3.8 million from CIRM. The funding was awarded under CIRM's Disease Team Therapy Development Award program (RFA 10-05) in September 2012.
"With CIRM's support, we have taken the first steps towards the development of a novel cell-based therapeutic for use in the treatment of Alzheimer's disease," commented Eliseo Salinas, MD, Executive Vice President and Head of Research & Development at StemCells, Inc. "Today, there are no good treatment options for Alzheimer's disease; in particular, there are no approved drugs which alter the progression of the disease. Furthermore, in the past few years, several drugs have failed in late-stage clinical trials. These drugs, like most of the treatments currently in development, target a single modality in a complex disease believed to result from a biological cascade probably triggered by multiple genetic and environmental factors. Cell-based therapies have the potential to provide a therapeutic benefit by acting on several relevant biological targets under the regulation of the host."
"We know from the preclinical work that our proprietary HuCNS-SC cells survive in the toxic environment of the Alzheimer's disease brain and restore memory under the regulation of the host. So rather than targeting a single mechanism in this cascade, our strategy is to provide healthy, self-renewing cells that can halt or slow disease progression and therefore preserve or restore cognitive function. Even a modest slowing of disease progression could translate into substantial improvements in quality of life for patients and families, as well as significant economic savings for society."
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. 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 were observed in the presence of amyloid deposition and increased tau, two toxic hallmarks of the disease, and provide the basis for a fundamentally different and novel approach to the treatment of Alzheimer's disease.
About 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 for patients afflicted by Alzheimer's disease. According to the Alzheimer's Association, approximately 5.4 million Americans have Alzheimer's disease, including nearly half of people aged 85 and older, and the prevalence of the disease is expected to increase rapidly as a result of the country's aging population. Moreover, the costs of the disease to society are significant - recent estimates range from $150 to $200 billion per year in the United States, with approximately three-quarters of those costs resulting from daily care either at home or in nursing facilities.
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 opportunities. A list of grants and loans awarded to date may be seen here: http://www.cirm.ca.gov/for-researchers/researchfunding.
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® cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company has shown preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. The Company is also conducting a Phase I/II clinical trial in chronic spinal cord injury in Switzerland and Canada and has reported positive interim data for the first three patients. The Company is also conducting a Phase I/II clinical trial in dry age-related macular degeneration (AMD), and is pursuing preclinical studies in Alzheimer's disease. StemCells also markets stem cell research products, including media and reagents, under the SC Proven® brand. Further information about StemCells is available at http://www.stemcellsinc.com.
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 potential of the Company's HuCNS-SC cells to treat a broad range of central nervous system disorders such as Alzheimer's disease; the prospect of initiating a clinical trial in Alzheimer's disease; the timing and prospects for funding by the California Institute for Regenerative Medicine; and the future business operations of the Company. 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 results of the Company's preclinical studies will be replicated in humans; uncertainties about whether the Company will satisfy, and continue to satisfy, all preconditions for funding from CIRM; uncertainties about the Company's ability to continue to satisfy the obligations under the Company's various loan agreements and repay these loans when due; 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; 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, 2012, and in its subsequent reports on Forms 10-Q and 8-K.
CONTACT: Rodney Young
Chief Financial Officer