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, today announced that the
six-month interim results for the first cohort in its ongoing Phase
II Pathway™ Study in cervical spinal cord injury (SCI) showed motor
improvements in both strength and function. The assessment of motor
function involved using tests of dexterity.
Patients eligible for the study have complete
loss of motor control below the level of injury, the most severe
degree of SCI as defined by the American Spinal Injury Association
Impairment Scale (AIS). Clinicians used both ISNCSCI (International
Standards for Neurological Classification of Spinal Cord Injury)
and GRASSP (Graded Assessment of Strength Sensibility and
Prehension) measures to establish a pre-transplant baseline for
each patient and to assess post-transplant progress.
This first cohort of the Pathway Study was
designed to assess the safety, and preliminary signs of efficacy,
of cell administration into the cervical cord and select the dose
level for the 40-patient second cohort, a randomized, controlled
and single-blinded arm of the trial, which is already underway.
Based on six-month follow-up, for the first
cohort, an overall pattern of motor improvement was detected in
four of the six patients as measured by gains in both strength and
function on the collective ISNCSCI and GRASSP outcomes.
Additional highlights of the six-month
interim results include:
- Muscle strength was improved in five of the six patients.
- Four of the five patients with gains in muscle strength also
demonstrated improved performance on functional tasks assessing
dexterity and fine motor skills.
- Four of the six patients had improvement in the spinal level of
injury as defined by the ISNCSCI assessment; three upgraded one
level and one upgraded two levels.
- Based on a Patient Global Impression of Change (PGIC)
assessment, four of the six patients reported that their condition
had improved post-transplant.
- Changes in muscle strength and function were observed around
three months post-transplant, consistent with the onset of sensory
improvements seen in the Company's Phase I/II thoracic study.
- No adverse events were attributed to the cells.
- The timing of the transplants ranged from ten to 23 months
post-injury.
“The early analyses of motor improvement from
the first cohort of the Pathway Study are consistent with an
evolution of the sensory outcomes seen in StemCells’ previous
thoracic study,” said Armin Curt, MD, the principal investigator at
the University of Zurich for the Company’s previous Phase I/II
thoracic spinal cord injury study. “The emerging data are the first
clinical evidence of a treatment effect improving muscle strength
and function following cellular transplant in spinal cord injuries.
These findings are even more compelling given that all the patients
are between one and two years post injury.”
“We do not expect to see spontaneous recovery in
spinal cord injury patients more than a year after their injury,”
added StemCells’ CMO and Vice President, Clinical Research, Stephen
Huhn, M.D., FACS, FAAP. “The improvements in upper extremity muscle
strength and function can be seen in specific tasks such as opening
a jar, picking up coins or grasping and turning a key. Gaining the
ability to perform these simple tasks should result in more
independence and an improved quality of life for those impacted by
spinal cord injuries. These findings demonstrate the ability of our
HuCNS-SC® cells to improve both muscle strength and motor function,
thereby changing the trajectory of recovery following a spinal cord
injury.”
“These are the results we have been waiting to
see in our spinal cord injury program. For the first time, we have
seen improvements in strength and motor function. While
preliminary, these results should come as really exciting news for
spinal cord injury patients and their families,” commented
StemCells’ CEO Martin McGlynn. “Until now, they have had little
hope for a therapy that might improve the quality of their lives.
These data are also very encouraging for the many StemCells
employees and stakeholders who remain steadfast to our mission to
address unmet medical needs through the use of novel cell-based
therapeutics which hold the promise of better treatments and
potential cures for a wide range of diseases and disorders of the
central nervous system.
“StemCells, Inc. would like to thank all of the
patients, their families and caregivers who are participating in
this study, along with the clinical investigators who are enabling
this groundbreaking research. It is their courage and leadership
that enables scientific advancement and the potential for exciting
new therapies.”
Live Webcast to Discuss the 6 Month
Interim Results is Scheduled Today at 4:30 PM ET (1:30 PM
PT)
StemCells, Inc. will host a webcast to discuss
the interim results from the Phase II clinical trial of HuCNS-SC
cells in spinal cord injury after market close today, November 18,
at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).
Live webcast:
http://edge.media-server.com/m/p/zmuy6r4y
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 in the
cervical region of the spinal cord. Conducted as a randomized,
controlled, single-blinded 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 Company’s, Inc. 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?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 platform technology (purified human
neural stem cells) as a potential treatment for both neurological
and retinal disorders. Top-line data from the Company's Phase I/II
clinical trial in thoracic spinal cord injury (SCI) showed
measurable gains involving multiple sensory modalities and
segments, including the conversion of two of seven patients
enrolled in the study with complete injuries to incomplete
injuries, post-transplant. The Company's Pathway Study, a Phase II
proof-of-concept trial in cervical SCI is actively enrolling at
twelve sites. The Company has also completed its Phase I/II
clinical trial in geographic atrophy dry age related macular
degeneration. Top-line results from this study show a positive
safety profile and favorable preliminary efficacy data. The
Company's Radiant™ Study, a Phase II multi-center proof-of-concept
trial in GA-AMD is now actively enrolling at three sites. 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.
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"); statements about the prospect
of generating statistically meaningful data from the Pathway Study;
statements about the nature and significance of the treatment
effect seen in the Pathway Study; and statements about and the
prospect for continued clinical development of the Company's
HuCNS-SC cells in CNS disorders. 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
uncertainties about whether preliminary data in any Phase I or
Phase II clinical study will prove to be reproducible or
biologically meaningful in any future clinical study; 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
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 whether results in preclinical research in animals will
be indicative of future clinical results in humans; uncertainties
regarding the Company's manufacturing capabilities given its
increasing preclinical and clinical commitments; 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, 2014 and in its subsequent reports on Forms 10-Q and
8-K.
CONTACT:
Greg Schiffman, Chief Financial Officer StemCells, Inc.
(510) 456-4128
Lena Evans
Russo Partners
(212) 845-4262
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