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
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
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 PhaseI 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
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
Chief Financial Officer
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