StemCells, Inc. Adds Byers Eye Institute at Stanford as Second Site for Phase I/II Clinical Trial in Dry Age-Related …

NEWARK, Calif., April 18, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced the addition of the Byers Eye Institute at Stanford, located in Palo Alto, Calif., as a second site for the Company's Phase I/II clinical trial of its proprietary HuCNS-SC(R) product candidate (purified human neural stem cells) in dry age-related macular degeneration (AMD). AMD is the leading cause of vision loss and blindness in people over 55 years of age, and approximately 30 million people worldwide are afflicted with the disease. Approximately 90 percent of AMD patients have the dry form of the disease and there are no approved treatments for dry AMD.

The Byers Eye Institute at Stanford, which is part of Stanford Hospital & Clinics, is dedicated to combating blindness and preserving sight. The Institute leverages the research and teaching strengths of Stanford and integrates all vision care services at Stanford into one state-of-the-art facility. Theodore Leng, MD, FACS, clinical assistant professor in ophthalmology at the Stanford University School of Medicine, is the lead investigator at the site. Stanford's Department of Ophthalmology is a nationally acclaimed leader for treatment of retinal diseases, refractive disorders, neuro-ophthalmic disorders and diseases of the vitrea.

"We are excited to be a part of this groundbreaking clinical trial for macular degeneration," said Dr. Leng. "The Company's preclinical data indicates that transplanting neural stem cells to protect photoreceptors may prove to be a viable approach to this debilitating disease. That data provides a very strong rationale for this innovative cell therapy trial."

"The clinical strategy with our neural stem cells is to preserve visual function before it is lost," said Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. "Our published preclinical data supports this approach in dry AMD and we hope to replicate those results in this clinical trial. We are very happy to be adding the Byers Eye Institute at Stanford and their participation is expected to accelerate patient enrollment for this trial."

The Company initiated the Phase I/II clinical trial last year at the Retina Foundation of the Southwest (RFSW) in Dallas, Texas. A summary of the Company's preclinical data underlying the trial was featured in the February 2012 issue of the international peer-reviewed European Journal of Neuroscience (available at http://onlinelibrary.wiley.com/doi/10.1111/j.1460-9568.2011.07970.x/abstract). The data demonstrated that HuCNS-SC cells protect host photoreceptors 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. Transplantation of HuCNS-SC cells into RCS rats significantly protected photoreceptors from degeneration. Moreover, the number of cone photoreceptors, which are responsible for central vision, remained constant over an extended period, consistent with the sustained visual acuity and light sensitivity observed in the study. In humans, degeneration of the cone photoreceptors accounts for the unique pattern of vision loss in dry AMD.

About Age-Related Macular Degeneration (AMD)

Age-related macular degeneration (AMD) refers to a loss of photoreceptors (rods and cones) from the macula, the central part of the retina. AMD is a degenerative retinal disease that typically strikes adults in their 50's or 60's, and progresses until central vision is lost. There are approximately 1.75 million Americans age 40 years and older with some form of AMD, and the disease continues to be the number one cause of irreversible vision loss among senior citizens in the United States with more than seven million at risk of developing AMD.

About the Clinical Trial

The Phase I/II trial is evaluating the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry age-related macular degeneration (AMD). The trial is an open-label, dose-escalation study, and is expected to enroll a total of 16 patients. The HuCNS-SC cells will be administered by a single injection into the space beneath the retina in the most affected eye. Patients' vision will be evaluated using both conventional and advanced state-of-the-art methods of ophthalmological assessment. Evaluations will be performed at predetermined intervals over a one-year period to assess safety and signs of visual benefit. Patients will then be followed for an additional four years in a separate observational study. 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.

About HuCNS-SC Cells

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StemCells, Inc. Adds Byers Eye Institute at Stanford as Second Site for Phase I/II Clinical Trial in Dry Age-Related ...