StemCells, Inc. Announces New Preclinical Data Showing HuCNS-SC(R) Cells Preserve Visual Function by Keeping Photoreceptors Normal and Healthy
NEWARK, Calif., Sept. 18, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM) today announced the publication of preclinical data confirming that the Company's proprietary HuCNS-SC cells (purified human neural stem cells) preserve photoreceptor cells and visual function in a widely used model of retinal degeneration. The data show not only that HuCNS-SC cells preserve the number of photoreceptors that would otherwise be lost, but also that the surviving photoreceptors appear healthy and normal, and maintain their synaptic connection to other important cells necessary for visual function. The study was published in Investigative Ophthalmology and Visual Science (IVOS), the journal of the Association for Research in Vision and Ophthalmology, and is available at (http://www.iovs.org/content/early/recent.) These results are highly relevant to disorders of vision loss, the most notable of which is age-related macular degeneration (AMD), which afflicts approximately 30 million people worldwide.
"This study demonstrates that, at the cellular and sub-cellular level, the surviving photoreceptors have all the components that characterize a healthy and normal photoreceptor, and they have the correct synaptic connections," said Nicolas Cuenca, PhD, Professor in the Department of Physiology, Genetics and Microbiology at the University of Alicante, Spain, and lead author of the paper. "The robust anatomical preservation of the photoreceptors and their synaptic connections most likely underlie the preservation of visual function.
"In addition, this study confirmed our preliminary hypothesis that HuCNS-SC cells phagocytose photoreceptor outer segments. The phagocytic activity of the HuCNS-SC cells restores a function normally performed by retinal pigmented epithelial (RPE) cells."
The Company is currently conducting a Phase I/II clinical trial in the dry form of AMD, the most prevalent form of the disease. The preclinical data underlying this Phase I/II clinical trial was previously published in the European Journal of Neuroscience (http://onlinelibrary.wiley.com/doi/10.1111/j.1460-9568.2011.07970.x/abstract). That data demonstrated that HuCNS-SC cells protect host photoreceptors (both rods and cones) and preserve vision in the Royal College of Surgeons (RCS) rat, a well-established animal model of retinal disease that has been used extensively to evaluate potential cellular therapies.
The Company's Phase I/II clinical trial in dry AMD is currently enrolling patients at the Byers Eye Institute at Stanford in Palo Alto, California, and at the Retina Foundation of the Southwest in Dallas, Texas. The Company recently dosed the first high-dose patient in the trial. To date, a total of five patients have been dosed in the 16-patient trial. Patients interested in participating in the clinical trial should contact the Byers Eye Institute at Stanford at (650) 498-4486 or the Retina Foundation of the Southwest at (214) 363-3911. The Company is working to open additional sites in the United States.
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 prospect of the Company's HuCNS-SC cells to preserve vision; the prospect and timing of patient enrollment in the Company's clinical trial in dry AMD; 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 in retinal disease will be replicated in humans; uncertainty as to whether the FDA or other applicable regulatory agencies or review boards will permit the Company to continue clinical testing in AMD; uncertainties regarding the timing and duration of any clinical trials; 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; 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 StemCells, Inc. Chief Financial Officer (510) 456-4128 Ian Stone Russo Partners (619) 308-6541