StemCells, Inc. (Nasdaq:STEM), a world leader in the research and
development of cell-based therapeutics for the treatment of
disorders of the central nervous system, announced today that it
has transplanted the first subject in its Phase II Pathway® Study
assessing the efficacy of its proprietary HuCNS-SC® (purified human
neural stem cells) platform technology for the treatment of
cervical spinal cord injury (SCI). The transplant was performed at
the University of Miami Hospital within the Miller School of
Medicine, home to The Miami Project to Cure Paralysis, one of the
world's most comprehensive spinal cord injury research centers
dedicated to finding effective treatments for paralysis.
"The participant tolerated the procedure well and is recovering
from the surgery as expected," said Allan D. Levi, M.D., Ph.D.,
F.A.C.S., Robert M. Buck Distinguished Chair in Neurological
Surgery at the University of Miami Miller School of Medicine and
Principal Investigator for the center. "Our center is a leader in
clinical research aimed at curing paralysis, and we are excited to
be participating in this breakthrough approach to spinal cord
injury repair. The Pathway study is designed to measure the
potential of these human neural stem cells, HuCNS-SC, as a possible
treatment for repairing some aspects of spinal cord injury.
Restoring or improving motor function would be life changing for
these patients."
The Pathway Study is the first clinical trial designed to
evaluate both the safety and efficacy of transplanting human neural
stem cells into patients with cervical spinal cord injury.
Traumatic injuries to the cervical (neck) region of the spinal
cord, also known as tetraplegia or quadriplegia, impair sensation
and motor function of the hands, arms, legs, and trunk. The trial
will be conducted as a randomized, controlled, single-blind study
and efficacy will be primarily measured by assessing motor function
according to the International Standards for Neurological
Classification of Spinal Cord Injury (ISNCSCI). The primary
efficacy outcome will focus on change in upper extremity strength
as measured in the hands, arms, and shoulders. The trial will
follow the participants for one year and will enroll up to 52
subjects.
"We are working with all due speed to pioneer a revolutionary
therapeutic approach for victims of spinal cord injury, a
debilitating condition that has significant unmet need and no
effective treatment," said Stephen Huhn, M.D., FACS, FAAP, Vice
President, Clinical Research and CMO at StemCells, Inc. "Enrollment
of the first patient with cervical injury is an important step in
our clinical development, which ultimately has the goal of
improving motor function and restoring a level of independence for
individuals living with chronic spinal cord injury. The Pathway
Study is a natural evolution from our Phase I/II trial in thoracic
spinal cord injury."
The Company completed enrollment and dosing in its open-label
Phase I/II study in thoracic spinal cord injury in May 2014 and has
reported interim results on all 12 subjects. Post-transplant gains
in sensory function below the level of injury were demonstrated in
half of the subjects. Two subjects converted from a complete injury
(AIS A) to an incomplete injury (AIS B). The interim results also
continue to confirm the favorable safety profile of the cells and
the surgical procedure.
About the Pathway Spinal Cord Injury Clinical
Trial
The StemCells, Inc. Pathway Phase II clinical trial, titled
"Study of Human Central Nervous System (CNS) Stem Cell
Transplantation in Cervical Spinal Cord Injury," will evaluate the
safety and efficacy of transplanting the Company's proprietary
human neural stem cells (HuCNS-SC cells), into patients with
traumatic injury in the cervical region of the spinal cord.
Conducted as a randomized, controlled, single-blind study, the
trial will measure efficacy by assessing motor function according
to the International Standards for Neurological Classification of
Spinal Cord Injury (ISNCSCI). The primary efficacy outcome will
focus on change in upper extremity strength as measured in the
hands, arms and shoulders. The trial will enroll approximately 52
subjects and follow the patients for 12 months post-transplant.
Information about the Company's spinal cord injury program can
be found on the StemCells, Inc. website at:
http://www.stemcellsinc.com
Patient testimonials from the Phase I/II study can be found
at:
http://www.stemcellsinc.com/News-Events/Video-Library.htm
Information for patients interested in participating in the
study is available at the Pathway website at:
http://www.sciresearchstudy.com
Additional information about the clinical trial is available
at:
http://clinicaltrials.gov/ct2/show/NCT02163876?term=stem+cells+cervical+spinal+cord+injury&rank=1
About HuCNS-SC Cells
StemCells, Inc. has demonstrated human safety data from
completed and ongoing clinical studies in which its proprietary
HuCNS-SC cells have been transplanted directly into all three
components of the central nervous system: the brain, the spinal
cord and the eye. StemCells, Inc. 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 HuCNS-SC platform technology is a
highly purified composition of human neural stem cells
(tissue-derived or "adult" stem cells). Manufactured under cGMP
standards, the Company's HuCNS-SC cells are purified, expanded in
culture, cryopreserved and then stored as banks of cells, ready to
be made into individual patient doses when needed.
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 U.S. securities laws, and is subject to the safe harbors
created therein. These statements include, but are not limited to,
statements regarding whether the improvements in sensory function
seen in the Company's Phase I/II clinical study of spinal cord
injury will persist and whether they will prove to be clinically
meaningful; the prospect for evaluating trial patients for changes
in their sensation, motor function and bowel/bladder function; the
potential of the Company's HuCNS-SC cells to treat spinal cord
injury and other central nervous system disorders; and the future
business operations of the Company, including its ability to
conduct clinical trials as well as its other research and product
development efforts. 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 will permit the Company to continue
clinical testing in spinal cord injury or in future clinical trials
of proposed therapies for other diseases or conditions;
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 manufacture viable cells sufficient to enroll the patients
planned for the Company's Phase II studies; 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 Form 10-Q and Form
8-K.
CONTACT: Greg Schiffman
StemCells, Inc.
Chief Financial Officer
(510) 456-4128
Andrea Flynn
Russo Partners
(646) 942-5631
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