StemCells, Inc. Publishes Comprehensive Review of Results From HuCNS-SC Clinical Trials

NEWARK, Calif., Sept. 9, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM) today announced the publication of a comprehensive overview describing the therapeutic potential and results from early clinical trials of the Company's proprietary HuCNS-SC® product candidate (purified human neural stem cells). The paper was published recently in Stem Cell Research & Therapy, an international peer-reviewed journal considered to be the major forum for translational research into stem cell therapies, and is part of a series about clinical applications of stem cells edited by Mahendra Rao, MD, PhD, Director, NIH Center for Regenerative Medicine.

"This review lays out the rationale and clinical translation strategy underlying our HuCNS-SC programs in central nervous system disorders," said Ann Tsukamoto, PhD, Executive Vice President, Scientific and Strategic Alliances at StemCells and lead author on the paper. "As a company, we have gone the extra mile to identify, prospectively purify and extensively characterize the biological activity of our neural stem cells, which has produced robust and reproducible results in a number of disease models. Our human neural stem cells are being developed for disorders of the brain, the spinal cord and the eye, so our results have been published in a number of respected journals specific to each of those areas. This paper provides an excellent summary of our data and progress to date in all areas."

Eliseo Salinas, MD, Executive Vice President and Head of Research and Development at StemCells, added, "To our knowledge, no other cell-based therapy has shown such robust preclinical evidence of biological effect. Our data to date highlight the promise of HuCNS-SC cells to address a broad spectrum of neurological disorders, as supported by our encouraging early clinical results, and we are working diligently towards proof of principle studies in AMD, PMD and spinal cord injury."

The overview describes the biological activity of the Company's HuCNS-SC cells, and explains the rationale and supporting data for pursuing neuroprotective strategies and clinical translation in a broad range of diseases and disorders of the central nervous system. The Company's preclinical studies have shown that the HuCNS-SC cells can:

  • protect host neurons by providing a missing enzyme in models of lysosomal storage disease,
  • produce myelin in models of dysmyelination,
  • restore motor function in a spinal cord injury models,
  • protect photoreceptors and preserve visual function in models of retinal degeneration, and
  • improve cognitive function in models relevant to Alzheimer's disease. 

Based on this preclinical data, the Company is pursuing a number of disease targets in clinical studies. 

  • Published results from the Company's Phase I clinical study in Pelizeaus-Merzbacher disease, a rare myelination disorder, show evidence of de novo myelin production in patients transplanted with HuCNS-SC cells, and
  • Interim data from the Company's ongoing Phase I/II clinical study show improved sensory function in spinal cord injured patients.  

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 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) at two sites in the United States.  In addition, the Company is pursuing preclinical studies in Alzheimer's disease, with support from the California Institute for Regenerative Medicine (CIRM).   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 timing and prospect of initiating a Phase II clinical trial in PMD and concluding the Company's on-going trials in spinal cord injury and AMD; the Company's ability to successfully execute its product development activities; 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, Swissmedic, Health Canada or other applicable regulatory agencies will permit the Company to continue clinical testing in spinal cord injury, AMD or in future clinical trials of proposed therapies for other diseases or conditions; 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 the results of the Company's preclinical studies will be replicated in humans; 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, 2012, and in its subsequent reports on Form 10-Q and Form 8-K.

CONTACT: Rodney Young
         StemCells, Inc.
         Chief Financial Officer
         (510) 456-4128
         
         Ian Stone
         Russo Partners
         (619) 308-6541

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