Safety and Preliminary Efficacy of Human Neural Stem Cells in StemCells, Inc.'s Dry AMD Study to be Presented at Ophthalmolog...
February 05 2015 - 8:00AM
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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