Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused
on the development of central nervous system therapies based on its
neural stem cell proprietary technology, announced that Karl Johe,
Ph.D., Chief Scientific Officer, presented the poster, “Therapeutic
Efficacy of NSI-189 in Diabetic Mice,” at the Annual Meeting of the
Diabetic Neuropathy Study Group of the EASD (European Association
for the Study of Diabetes), held in Bucharest, Romania, on
September 11th. The data demonstrate the potential for NSI-189 to
reverse neuropathies resulting from diabetes in two well-recognized
animal models.
Researchers, led by Nigel Calcutt, Ph.D., at University of
California San Diego School of Medicine, showed that NSI-189
significantly protected nerve function and structure in mice with
induced type 1 diabetes, when given at the beginning of disease,
and improved the nerve function and structure, when given eight
weeks after disease onset. The mice were evaluated along several
well-established indices of neuropathy, including: slowing of motor
nerve conductance velocity, painful hypersensitivity of skin,
insensitivity to heat, and reduction in dermal and epidermal nerve
fiber density. Treatment with NSI-189 significantly improved all of
these indices, in comparison to vehicle-treated diabetic animals.
Additionally, in a genetic model of type 2 diabetes (db/db mouse),
NSI-189 treatment showed significant reversal in all of the same
indices of neuropathy.
“Diabetes causes irreversible damage to both the central and the
peripheral nervous systems,” said Nigel Calcutt, Ph.D., lead author
and Professor of Pathology at University of California San Diego
School of Medicine. “This study demonstrates that NSI-189 may have
potential to reduce, and in some cases, reverse the neuropathies
caused by diabetes, promoting structural changes that normalize
heat and pain sensitivities. If further studies confirm this, we
could foresee translation of this therapy into clinical
investigation in humans.”
NSI-189, Neuralstem’s lead neurogenic compound, is in a Phase 2b
multi-center trial for the treatment of major depressive disorder
(MDD). The company expects to report results in the second half of
2017.
In earlier preclinical studies, the antidepressant and
neurogenic effects of NSI-189 were shown to be mediated by a novel
mechanism of action and not by either direct inhibition of
serotonin or norepinephrine re-uptake or by direct induction of
brain-derived neurotrophic factor (BDNF) release, therefore
differentiating NSI-189 from currently-available antidepressants.
Additionally, receptor-binding studies show that NSI-189 has no
appreciable binding activity for known neurotransmitter receptors,
transporters, or kinases, suggesting a novel mechanism of
action.
“We have been assessing NSI-189’s potential therapeutic utility
outside of MDD,” said Karl Johe, PhD, Neuralstem’s Chief Scientific
Officer. “Various preclinical studies demonstrate its neurogenic
and synaptogenic capacity in the central nervous system. The
diabetes study shows NSI-189’s neuroregenerative capacity in the
peripheral nervous system. We look forward to further
evaluating its neuroregenerative capacity in the central nervous
system in future studies such as diabetes-induced central
neuropathies which result in cognitive impairment.”
To view the poster, please visit
http://www.neuralstem.com/pdf/NeuroDiab2016NeuralstemP37final.pdf.
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 ability to generate neural stem cell lines from
human hippocampus, which were used for systematic chemical
screening for neurogenesis effect, 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, its first 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 first stem cell product candidate, NSI-566, a
spinal cord-derived neural stem cell line, is under development for
treatment of amyotrophic lateral sclerosis (ALS). Neuralstem has
completed two clinical studies, in a total of thirty patients,
which met primary safety endpoints. In addition to ALS, NSI-566 is
also in a Phase 1 study to treat paralysis due to chronic spinal
cord injury, as well as in a Phase 1 study to treat paralysis from
ischemic stroke.
Cautionary Statement Regarding Forward Looking Information:
This 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 filed with the Securities
and Exchange Commission (SEC) on March 14, 2016, Form
10-Q for the period ended June 30, 2016, and in other reports
filed with the SEC.
Contact:
Neuralstem – Investor Relations:
Danielle Spangler
301.366.1481
Planet Communications - Media Relations:
Deanne Eagle
917.837.5866
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