StemCells, Inc. Presents Interim Results from its Phase II Pathway Study in Chronic Cervical Spinal Cord Injury at ASIA Annua...
April 18 2016 - 8:05AM
StemCells, Inc. (NASDAQ:STEM), a world leader in the research and
development of cell-based therapeutics for the treatment of central
nervous system disorders, announced today that Dr. Stephen Huhn,
the Company’s Chief Medical Officer and VP of Clinical Research,
presented additional details on its ongoing Phase II Pathway™ Study
of HuCNS-SC cells for the treatment of chronic cervical spinal cord
injuries. The presentation, which took place at the 2016
American Spinal Injury Association (ASIA) annual meeting in
Philadelphia on Friday, April 15, included a top line update for
the six patients enrolled in open label Cohort I from the Pathway
Study. The 6-month results from Cohort I showed that muscle
strength had improved in five of the six patients with four of
these five patients also demonstrating improved performance on
functional tasks assessing dexterity and fine motor skills. In
addition, four of the six patients had improvement in the level of
cord injury as measured by ISNCSCI (International Standards for
Neurological Classification of Spinal Cord Injury) assessment. The
Company expects to release detailed final 12-month results on this
first open-label cohort later this quarter.
"The emerging data continue to be very
encouraging," said Dr. Huhn. "We believe that these types of motor
changes will improve the independence and quality of life of
patients and are the first demonstration that a cellular therapy
has the ability to impact recovery in chronic spinal cord injury.
We currently have thirteen sites in the United States and Canada
that are actively recruiting patients. We have enrolled and
randomized 19 of the 40 total patients in the statistically
powered, single-blind, randomized controlled, Cohort II. We are
projecting to complete enrollment by the end of September so that
we can have final results in 2017.”
About the Pathway Spinal Cord Injury
Clinical Trial
The Phase II Pathway Study, 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 of the
cervical region of the spinal cord. Cohort I is an open label
dose-ranging cohort in six AIS-A or AIS-B subjects. Cohort II
is a randomized, controlled, single-blinded cohort in forty AIS-B
subjects. Cohort III, at the discretion of the sponsor, is an
open-label arm involving six AIS-C subjects. The study 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 up to 52 subjects.
Enrollment of Cohort I has been completed and the Company is
now enrolling patients into Cohort II.
Information about the Company’s spinal cord
injury program can be found on the Company’s website at:
http://www.stemcellsinc.com/Clinical-Programs/SCI
Information on the Company’s pre-clinical spinal
cord injury research, along with an animation on the science of
HuCNS-SC cells for the treatment of spinal cord injuries, can be
found at:
http://www.stemcellsinc.com/Science/Pre-Clinical-Studies/About-SCI
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
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® platform technology (purified human
neural stem cells) as a potential treatment for chronic spinal cord
injury (SCI). The Company's Pathway Study, a Phase II
proof-of-concept trial in chronic cervical SCI is actively
enrolling at thirteen sites in the U.S. and Canada. Six-month
interim data for the first cohort of the Pathway Study showed the
first-ever clinical evidence of a treatment effect improving both
upper muscle strength and motor function following cellular
transplant in spinal cord injury. Top-line data from the Company's
earlier Phase I/II clinical trial in chronic thoracic SCI showed
measurable gains involving multiple sensory modalities and segments
in seven of twelve patients enrolled in the study, including the
conversion of two patients from the complete AIS-A spinal cord
injury to the incomplete AIS-B spinal cord injury. The Company has
also completed its Phase I/II clinical trial in geographic atrophy,
the most advanced form of dry age related macular degeneration.
Top-line results from this study show a positive safety profile and
favorable preliminary efficacy data. 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 by MRI. A Phase I study in
children with Batten’s disease showed that transplantation of the
cells into the brain was safe and resulted in long term survival of
the 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 the future business operations of StemCells,
Inc. (the "Company"), the prospect for continued clinical
development of the Company's HuCNS‑SC cells in CNS disorders, the
timing of final data release in the Company’s Pathway Study in
cervical spinal cord injury, and the belief that the improvements
observed in the Pathway Study will have a meaningful impact on the
quality of life and independence of patients in the study. 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 risks whether the FDA or other applicable
regulatory agencies, including applicable institutional review
boards at one or more clinical trial sites, will permit the Company
to continue clinical testing or conduct future clinical trials;
uncertainties regarding the timing of patient enrollment in the
Company’s Pathway Study; 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; uncertainties
regarding the Company's manufacturing capabilities given its
increasing preclinical and clinical commitments; uncertainties
regarding the Company’s plans to increase its authorized share
capital; uncertainties regarding the validity and enforceability of
the Company's patents; uncertainties as to whether the Company will
become profitable; 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, 2015.
CONTACT:
Greg Schiffman, Chief Financial Officer StemCells, Inc.
(510) 456-4128
Lena Evans
Russo Partners
(212) 845-4262
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