Neuralstem Expands Phase 1 Safety Trial of NSI-566 Neural Stem Cells in Spinal Injury
April 12 2017 - 7:35AM
Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused
on the development of nervous system therapies based on its neural
stem cell technology, announced that a new cohort of four patients
will be added to its ongoing Phase 1 human clinical trial
evaluating the safety and feasibility of using NSI-566 spinal
cord-derived neural stem cells to repair chronic spinal cord injury
(cSCI). The amended protocol was approved by the U.S. Food
and Drug Administration and the Institutional Review Board at the
study site, University of California San Diego (UCSD).
NSI-566 is Neuralstem’s lead stem cell therapy candidate.
Under the amended protocol, updated on clinicaltrials.gov
(NCT01772810), four qualifying patients with AIS-A complete,
quadriplegic, cervical injuries involving C5-C7 cord will be added
to the study. The injury must have occurred 1-2 years prior
to the time of stem cell treatment, which is a one-time surgery
involving six injections of NSI-566 into the affected area of the
cord. The study has begun active recruitment of patients.
About 250,000 Americans are living with cSCI, and approximately
11,000 new injuries are reported each year1. Roughly 52% of these
individuals will be considered paraplegic and 47% will be
considered quadriplegic1. cSCI is a permanent and disabling
condition with few to no treatments. Its devastating effect
can be measured from social, healthcare, and economic
perspectives.
“This expansion of the study to cervical injuries builds on the
results demonstrating that the implantation of NSI-566 stem cells
in the first four patients with AIS-A complete thoracic cSCI was
safe and feasible with no serious adverse events,” said Karl Johe,
Ph.D., Chief Scientific Officer, Neuralstem. “There is a
tremendous unmet need in the treatment of cSCI and we are
privileged to have the experts at UCSD School of Medicine and the
Sanford Stem Cell Clinical Center at UC San Diego Health conducting
the research. We look forward to further evaluating NSI-566
neural stem cells in chronic complete cervical injuries."
Long-term safety data from the first cohort of chronic complete
thoracic injuries is currently being analyzed by the study team at
UCSD School of Medicine.
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 also 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.
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1 http://www.sci-info-pages.com/facts.html
Contact:
Danielle Spangler
Director of Investor Relations, Neuralstem
301-366-1481
dspangler@neuralstem.com
Kimberly Minarovich
Argot Partners (Investor Relations)
212-600-1902
kimberly@argotpartners.com
Lori Rosen
LDR Communications (Public Relations)
917-553-6808
lori@ldrcommunications.com
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