NEWARK, Calif., Feb. 5, 2015 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM), a leading stem cell company developing novel cell-based therapeutics for disorders of the central nervous system, announced today that Theodore Leng, MD, MS, Clinical Assistant Professor of Ophthalmology at the Byers Eye Institute at Stanford, Stanford University School of Medicine and a principal investigator on StemCells, Inc.'s Phase I/II study in dry age related macular degeneration will be presenting findings on the safety and preliminary efficacy of HuCNS-SC®, human neural stem cells, for dry age related macular degeneration (AMD) at the Angiogenesis, Exudation and Degeneration 2015 symposium. Dr. Leng will present at 12:40 p.m. EST. AMD is the leading cause of blindness in people over the age of 50 and today there are no approved therapies to treat dry AMD. This symposium is hosted by the Bascom Palmer Eye Institute at the University of Miami Miller School of Medicine. The symposium will be held February 7, 2015 at the Mandarin Oriental Hotel in Miami, Florida.
The one day symposium attracts basic scientists, clinicians, and healthcare experts, all focused on diseases of the eye. The meeting highlights revolutionary therapies now in development and clinical practice for the management of diseases of the eye, with a focus on neo-vascular AMD, macular edema, diabetic retinopathy, and retinopathy of prematurity.
Previously the Company has reported that preliminary interim findings for those subjects with one year of follow-up post-transplant show a reduction in the rate of geographic atrophy (GA) in the study eye when compared to both expected natural history of the disease and the untreated control eye. GA is the progressive loss of two important retinal tissue layers, the photoreceptors and the retinal pigmented epithelium. This degeneration is the cause of vision loss in dry AMD. In addition, interim results also indicate either stable or improved visual acuity and contrast sensitivity (the ability to distinguish shades of light versus dark) at 6 and 12 months post-transplant.
About HuCNS-SC Cells
StemCells, Inc. has demonstrated human safety data from completed and ongoing clinical studies of its proprietary HuCNS-SC cells. StemCells clinicians and scientists believe that HuCNS-SC cells may have broad therapeutic application for many diseases and disorders of the CNS. Because the transplanted HuCNS-SC cells have been shown to engraft and survive long-term, there is the possibility of a durable clinical effect following a single transplantation. The Company’s preclinical research established that HuCNS-SC cells can be directly transplanted in the central nervous system (CNS) with no sign of tumor formation or adverse effects. The HuCNS-SC platform technology is a highly purified composition of human neural stem cells that are expanded and stored as banks of cells.
About StemCells, Inc.
StemCells, Inc. is currently engaged in clinical development of its HuCNS-SC (purified human neural stem cells) platform technology, as a potential treatment for diseases and disorders of the central nervous system. Interim data from the Company’s Phase I/II clinical trial in thoracic spinal cord injury shows measurable gains involving multiple sensory modalities and segments in half of the subjects, two of whom converted from complete injury (AIS A) to incomplete injury (AIS B), post-transplant. Enrollment has recently commenced in the Company’s Phase II clinical trial in cervical SCI. StemCells, Inc. has also completed enrollment and treatment in its Phase I/II clinical trial in geographic atrophy of age-related macular degeneration (GA-AMD), the most severe form of dry AMD, which is the leading cause of blindness in the elderly. Interim results for those subjects with 12 month follow-up post transplantation of HuCNS-SC cells into the eye, show a reduction in the rate of disease progression as compared to the control (untreated) eye and to the expected natural history of the disease. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company showed preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. Further information about StemCells, Inc. 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 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, 2013, and in its subsequent reports on Forms 10-Q and 8-K.
CONTACT: Greg Schiffman StemCells, Inc. Chief Financial Officer (510) 456-4128 Andrea Flynn Russo Partners (646) 942-5631
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