GERMANTOWN, Md., June 19, 2014 /PRNewswire/ -- Neuralstem,
Inc. (NYSE MKT: CUR) announced that select data from the NSI-189
Phase Ib trial in patients with major depressive disorder (MDD)
will be presented at the International
College of Neuropyschopharmacology (CINP) 2014 World
Congress, in Vancouver, Canada. A
poster entitled, "Effects of NSI-189, a neurogenic compound, on
quantitative electroencephalography (qEEG) in patients with
major depressive disorder (MDD) during a phase 1b randomized,
double-blinded, placebo controlled, multiple ascending dose study,"
will be presented in the session "Biomarkers (incl.
pharmacogenomics and brain imaging) for diagnosis and treatment
response" on June 24th from
5:15 to 6:45 p.m. PDT.
During the course of the NSI-189/MDD Phase Ib trial, patients
underwent quantitative electroencephalography brain measurements,
in addition to the clinical tests reported earlier this week. In
the study to be presented at CINP
(https://www1.cinp-congress.org/guest/ID30b935a2860cf8/AbstractView?ABSID=11795),
researchers reported that NSI-189 had a measurable impact on the
brain waves of patients on active therapy who showed increased
high-frequency brain wave activity in the left temporal region,
where the hippocampus is located, compared to placebo. This finding
is consistent with improvement in left temporal lobe function and
may also reflect changes in activity in the left mesial temporal
lobe and hippocampus, and changes in patient clinical
responses.
"These findings validate our hypothesis, demonstrated in
in-vitro and animal studies, that NSI-189 stimulates the
neurogenesis of hippocampal stem cells," said Karl Johe, PhD, Neuralstem's Chairman and Chief
Scientific Officer and a study author. "These EEG findings show
that the hippocampal region is, indeed, where a significant change
in brain wave activity is taking place in patients on active
therapy, and corroborates our theory that NSI-189 targets the
hippocampus. It is the first physical proof in humans. Taken
together with the significant patient clinical improvements
reported earlier in the week, we are encouraged that NSI-189 may be
affecting the physical structure of the brain in these depression
patients."
About Major Depressive Disorder
Major depressive disorder (MDD), also called major depression,
is characterized by a combination of symptoms that interfere with a
person's ability to function normally. MDD affects approximately
14.8 million American adults and is the leading cause of disability
in the U.S. for ages 15-44, according to the National Institute of
Mental Health. While most treatments modulate brain
neurotransmitter levels to treat brain chemistry, new research
suggests that brain physiology could also be involved. Depressed
patients have reduced volume in the hippocampus, a part of the
brain that generates new neurons. Neuralstem believes that
stimulating the generation of new neurons in the hippocampus could
potentially address the pathology of the depression itself.
About Neuralstem
Neuralstem's patented technology enables the production of
neural stem cells of the brain and spinal cord in commercial
quantities, and the ability to control the differentiation of these
cells constitutively into mature, physiologically relevant human
neurons and glial cells. Neuralstem's NSI-566 spinal cord-derived
stem cell therapy is in Phase II clinical trials for amyotrophic
lateral sclerosis (ALS), often referred to as Lou Gehrig's disease. Neuralstem has been
awarded orphan status designation by the FDA for its ALS cell
therapy.
In addition to ALS, the company is also targeting major central
nervous system conditions with its NSI-566 cell therapy platform,
including spinal cord injury and ischemic stroke. The company has
received FDA approval to commence a Phase I safety trial in chronic
spinal cord injury.
Neuralstem also maintains the ability to generate stable human
neural stem cell lines suitable for systematic screening of large
chemical libraries. Through this proprietary screening technology,
Neuralstem has discovered and patented compounds that may stimulate
the brain's capacity to generate neurons, possibly reversing
pathologies associated with certain central nervous system
conditions. The company has completed a Phase I safety trial
evaluating NSI-189, its first neurogenic small molecule product
candidate, for the treatment of major depressive disorder (MDD).
Additional indications might include traumatic brain injury (TBI),
Alzheimer's disease, and post-traumatic stress disorder (PTSD).
For more information, please visit www.neuralstem.com or connect
with us on Twitter, Facebook and LinkedIn
Cautionary Statement Regarding Forward Looking
Information:
This news release may contain forward-looking statements made
pursuant to the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. Investors are cautioned that such
forward-looking statements in this press release regarding
potential applications of Neuralstem's technologies constitute
forward-looking statements that involve risks and uncertainties,
including, without limitation, 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, 2013 and Form 10Q, for the period
ended March 31, 2014.
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SOURCE Neuralstem, Inc.