StemCells, Inc. Announces Webcast to Discuss Interim Results From the First Cohort in Its Phase II Study in Cervical Spinal C...
November 12 2015 - 8:05AM
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, will host a webcast to
discuss the six-month interim results from the first cohort in its
Phase II PathwayTM Study in cervical spinal cord injury. The
Company will also provide a progress update on the second
40-patient cohort which is currently enrolling patients.
The first cohort is an open-label dose
escalation arm used to determine the cell dose for the second
cohort of the study. The second cohort is a randomized,
single-blind study expected to enroll 40 motor complete patients,
these are patients with complete loss of motor function below the
point of injury. This cohort is statistically powered to
demonstrate efficacy of the Company’s proprietary HuCNS-SC®
platform technology (purified human neural stem cells) for the
treatment of cervical spinal cord injury. The patients in the first
and second cohorts undergo all of the same clinical safety and
efficacy assessments. All patients in the study will be
followed for 12 months post-transplant. Final results from this
first cohort will be available Q2 2016, and final results from the
study are expected in 2017.
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 on Wednesday,
November 18, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific
Time).
Interested parties are invited to listen to the
webcast over the Internet by accessing the Investors section of the
Company's website at www.stemcellsinc.com. Webcast participants
should allot extra time before the webcast begins to register and,
if necessary, download and install audio software.
Event:
Clinical update, and top line interim data analysis, of the
Pathway, Phase II Spinal Cord Injury Study
Date:
Wednesday, November 18, 2015
Time:
4:30 PM ET (1:30 PM PT)
Live webcast:
http://edge.media-server.com/m/p/zmuy6r4y
An archived version of the webcast will be
available for replay on the Company's website beginning
approximately two hours following the conclusion of the live call
and continuing for a period of 90 days.
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-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/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") 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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