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|StemCells, Inc. to Present Clinical Evidence of Long-Term Survival of HuCNS-SC(R) Cells Following Completion of Immunosuppression Regimen|
PALO ALTO, Calif., Jun 15, 2011 (GlobeNewswire via COMTEX) --
StemCells, Inc. (Nasdaq:STEM) announced today that it will present evidence of engraftment, migration and the long-term survival of its proprietary HuCNS-SC neural stem cells following transplantation into patients with a severe neurological disorder. Importantly, the results show that the cells can persist following the completion of the planned year-long immunosuppression regimen. The data, which supports the Company's premise regarding the viability and utility of neural stem cell therapy as a potential treatment for a wide range of debilitating and lethal central nervous system (CNS) disorders, will be reported at the International Society for Stem Cell Research (ISSCR) 9th Annual Meeting, June 15-18 in Toronto, Ontario, by Nobuko Uchida, Vice President, Stem Cell Biology at StemCells, Inc.
"These findings support our vision of a one-time transplantation of stem cells with a lasting clinical benefit," said Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. "In a field of promises, we now have confirmation that we are on the right path. Ultimately, we hope to show that our HuCNS-SC human neural stem cells can dramatically impact a broad spectrum of neurological disorders."
The durability of the Company's HuCNS-SC human neural stem cells within the hostile inflammatory environment of the diseased brain is only one important aspect of the results being presented. The authors also report the persistence of the transplanted donor cells long after immunosuppressive treatment has been discontinued. This finding is significant because other allogeneic tissue and organ transplants usually require life-long immunosuppression, which carries increased risk for cancer and opportunistic infections. The data to be presented by StemCells, Inc. also support the belief that the central nervous system is "immune-privileged" and that a relatively brief period of immunosuppression may be all that is required to avoid the risk of transplant rejection within the CNS. Additional studies will determine whether immunosuppression protocols can be further optimized.
The data to be presented was derived from postmortem examinations of three patients in the Company's Phase I clinical trial of HuCNS-SC cells in neuronal ceroid lipofuscinosis (NCL, also referred to as Batten disease), a rare and fatal neurodegenerative disorder in children. The patients expired from causes related to the underlying disease. Analysis of the brain tissue of two of the patients at autopsy revealed the presence of the donor cells at the sites of transplantation as well as evidence of migration into deeper structures of the brain, confirming similar observations made in animal models. In one of these patients, the persistence of the donor cells was evident 2.5 years post transplant and 1.5 years after completion of the immunosuppression regimen.
The International Society for Stem Cell Research (ISSCR) is an independent, nonprofit organization established to promote and foster the exchange and dissemination of information and ideas relating to stem cells, to encourage the general field of research involving stem cells and to promote professional and public education in all areas of stem cell research and application. The ISSCR Annual Meeting is the preeminent meeting of stem cell experts from public, private, academic, and government institutions from around the world, and provides a forum which features the leading research and discoveries of the year.
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 U.S. securities laws, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the clinical development of the Company's HuCNS-SC cells; the long-term survival and effect of HuCNS-SC cells within the human body; the potential of HuCNS-SC cells to treat neurodegenerative diseases and central nervous system disorders; 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 FDA or other applicable regulatory agencies will permit the Company to continue clinical testing in PMD, spinal cord injury 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 obtain the increased capital resources needed to continue its current and planned research and development operations; uncertainty as to whether HuCNS-SC 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; uncertainties regarding the Company's manufacturing capabilities given its increasing preclinical and clinical commitments; 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 (650) 475-3128