Neuralstem Announces Publication of NSI-566 Data in a Rodent Model of Traumatic Brain Injury
March 09 2017 - 7:03AM
-NSI-566 Achieved Robust Engraftment and
Long-Term Survival After Transplantation-
Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused
on the development of nervous system therapies based on its neural
stem cell technology, announced the recent publication of
preclinical data on NSI-566 spinal cord-derived neural stem cells
in Journal of Neurotrauma. These data showed robust
engraftment and long-term survival of NSI-566 post transplantation
in a rat model of penetrating ballistic-like brain injury
(PBBI). NSI-566 is Neuralstem’s lead stem cell therapy
candidate.
The study entitled, “Amelioration of penetrating ballistic-like
brain injury induced cognitive deficits after neuronal
differentiation of transplanted human neural stem cells," was led
by Ross Bullock, M.D., Ph.D., The Miami Project to Cure Paralysis,
University of Miami School of Medicine. These are the first
data from the 4-year proof-of-concept research program, funded by
the United States Department of Defense, for NSI-566 in traumatic
brain injury.
“These data on NSI-566 are encouraging, particularly since
researchers have long been challenged to achieve durable
engraftment and survival of neural stem cells after
transplantation,” said Dr. Bullock. “No long-term
treatment beyond physical therapy is currently available to restore
cognition after a traumatic brain injury. Transplantation of
stem cells into the injured brain may allow a unique replacement
therapy and fill a significant medical need.”
Researchers transplanted NSI-566 into rats 7-10 days after
PBBI. The rats were immunosuppressed to enable survival of
NSI-566 neural stem cells. Robust engraftment with evidence
of prominent neuronal differentiation was observed after 4 months,
and axons from grafted cells extended a significant distance from
the graft site along host white matter tracts.
“These data continue to support our research and development
platform. The results provide additional insight into our
proprietary regionally specific stem cells and their potential
benefits in nervous system disorders,” said Karl Johe, Ph.D., Chief
Scientific Officer, Neuralstem. “We look forward to
additional preclinical data from this collaboration with Dr.
Bullock’s group to support the potential use of NSI-566 in
traumatic brain injury.”
About Neuralstem Neuralstem’s patented
technology enables the commercial-scale production of multiple
types of central nervous system stem cells, which are being
developed as potential therapies for multiple central nervous
system diseases and conditions.
Neuralstem’s technology enables the discovery of small molecule
compounds by systematic screening chemical compounds against its
proprietary human hippocampal stem cell line. The screening
process has led to the discovery and patenting of molecules that
Neuralstem believes may stimulate the brain’s capacity to generate
new neurons, potentially reversing pathophysiologies associated
with certain central nervous system (CNS) conditions.
The company has completed Phase 1a and 1b trials evaluating
NSI-189, a novel neurogenic small molecule product candidate, for
the treatment of major depressive disorder or MDD, and is currently
conducting a Phase 2 efficacy study for MDD.
Neuralstem’s stem cell therapy product candidate, NSI-566, is a
spinal cord-derived neural stem cell line. Neuralstem is currently
evaluating NSI-566 in three indications: stroke, chronic spinal
cord injury (cSCI), and Amyotrophic Lateral Sclerosis (ALS).
Neuralstem is conducting a Phase 1 safety study for the
treatment of paralysis from chronic motor stroke at the BaYi Brain
Hospital in Beijing, China. In addition, NSI-566 was
evaluated in a Phase 1 safety study to treat paralysis due to
chronic spinal cord injury as well as a Phase 1 and Phase 2a risk
escalation, safety trials for ALS. Subjects from all three
indications are currently in long-term observational follow-up
periods to continue to monitor safety and possible therapeutic
benefits.
Cautionary Statement Regarding Forward Looking
InformationThis news release contains “forward-looking
statements” made pursuant to the “safe harbor” provisions of the
Private Securities Litigation Reform Act of 1995. Such
forward-looking statements relate to future, not past, events and
may often be identified by words such as “expect,” “anticipate,”
“intend,” “plan,” “believe,” “seek” or “will.” Forward-looking
statements by their nature address matters that are, to different
degrees, uncertain. Specific risks and uncertainties that could
cause our actual results to differ materially from those expressed
in our forward-looking statements include risks inherent in the
development and commercialization of potential products,
uncertainty of clinical trial results or regulatory approvals or
clearances, need for future capital, dependence upon collaborators
and maintenance of our intellectual property rights. Actual results
may differ materially from the results anticipated in these
forward-looking statements. Additional information on potential
factors that could affect our results and other risks and
uncertainties are detailed from time to time in Neuralstem’s
periodic reports, including the Annual Report on Form 10-K for the
year ended December 31, 2015, and Form 10-Q for the nine months
ended September 30, 2016, filed with the Securities and Exchange
Commission (SEC), and in other reports filed with the SEC. We do
not assume any obligation to update any forward-looking
statements.
Contact:
Danielle Spangler
Investor Relations
Neuralstem, Inc
301.366.1481
Lori Rosen
Public Relations
LDR Communications
917.553.6808
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