GERMANTOWN, Md.,
Nov. 17, 2014
/PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR)
announced that blood-based biomarkers for major depressive disorder
(MDD) identified a rapid response to NSI-189 in the Phase Ib
MDD trial. In the poster "Biomarker Profiling of
NSI-189 Phosphate, a Neurogenic Compound, in Patients with Major
Depressive Disorder (MDD) during a Phase Ib Randomized
Double-Blind, Placebo-Controlled Trial," presented on Friday at the
CNS Summit in Boca Raton, FL
(http://www.cnssummit.org), researchers concluded that NSI-189 is
rapidly and persistently efficacious. Furthermore, they suggest
that it may be possible to predict a patient's response to the drug
from baseline biomarker profiling.
These results are consistent with clinical data
results, reported at the American Society of Clinical
Psychopharmacology (ASCP) Annual Meeting in June, that showed a
significant number of patients on active treatment demonstrated
clinical improvement by a reduction in total Montgomery–Asberg
Depression Rating Scale (MADRS) scores >/= 15.9 points, which
continued 8 weeks after dosing stopped. This sustained drop
was to a point at, or near, what is usually associated with
remission on SSRI compounds. MADRS is a commonly-used clinical
assessment scale to determine depression severity. NSI-189 is
Neuralstem's first-in-class, lead neurogenic small molecule
compound, shown to promote neurogenesis in vitro. In animal
studies, NSI-189 resulted in a significant increase in hippocampal
volume. Quantative EEG Phase Ib analysis, also reported in
June, showed that active therapy patients had significantly
increased brain wave patterns in the hippocampal region of the
brain.
"This is a small study, but we believe these established
markers of depression, such as plasma levels of the stress
hormone, cortisol, as well as neurotrophic factors, offer further
biometric-based confirmation that NSI-189 appears to be
demonstrating neurogenesis in the brain, as hypothesized and shown
in animal studies," said Karl Johe,
PhD, Neuralstem Chairman and Chief Scientific Officer. "There was
little difference in baseline markers between control and active
therapy patients at the beginning of the study. Upon commencing
therapeutic dosing, a difference in depression biomarkers emerged
between the groups within days and continued to improve through the
28-day treatment for the two lower-dose arms. Furthermore,
during the non-dosing 8-week follow-up period, these two cohorts
showed sustained benefits signaling sustained hippocampal
neurogenesis."
"NSI-189 is a novel neurogenic compound that has shown
promise as a potential treatment for MDD in a Phase 1B,
double-blind, randomized, placebo-controlled, multiple-dose study
with three ascending cohorts," said study author and principal
investigator in the Phase I trial, Maurizio
Fava, MD, Executive Vice Chair, Department of Psychiatry and
Executive Director, Clinical Trials Network and Institute,
Massachusetts General Hospital. "Preliminary analysis of this small
sample set suggests that prediction of response to NSI-189 may be
possible from baseline peripheral biomarker profiling."
"This data continues to validate the development of
NSI-189 as a potentially new class of antidepressants that act via
neurogenesis, a fundamentally different mechanism of action than
current treatments, which have a low success rate," said
Richard Garr, Neuralstem President
and CEO. "We plan to launch a large, multi-site Phase II
study in the second quarter of 2015.
About the Trial
In this single-site study, 24 patients with
confirmed diagnosis of recurrent major depressive disorder (MDD),
were treated orally with NSI-189 in three equal dose cohorts
(8/dose cohort; 40mg QD, 40mg BID, and 40mg TID) for 28 days. Each
dose cohort consisted of randomized, double-blinded, placebo
controls at 1:3 ratio of placebo: drug. All subjects stayed
in-clinic for the 28-day treatment period. After this period,
the subjects returned to the clinic for follow-up measures for up
to additional 8 weeks post dosing.
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
multiple types of brain and spinal cord neural stem cells in
commercial quantities for the potential treatment of central
nervous system diseases and conditions. Neuralstem's first stem
cell product, NSI-566, a spinal cord-derived neural stem cell line,
is in an ongoing clinical trial to treat amyotrophic lateral
sclerosis (ALS, or Lou Gehrig's
disease). Phase II surgeries were completed in July, 2014. A later
stage trial is anticipated to commence in 2015 at multiple centers.
Neuralstem received orphan status designation by the FDA for
NSI-566 in ALS. In addition to ALS, NSI-566 is also in a Phase I
trial in chronic spinal cord injury at UC San Diego School of
Medicine. NSI-566 is also in clinical development to treat
neurological diseases such as ischemic stroke and acute spinal cord
injury.
Neuralstem's second stem cell product, NSI-532.IGF,
consists of human cortex-derived neural stem cells that have been
engineered to secrete human insulin-like growth factor 1 (IGF-1).
In animal data presented at the Congress of Neurological Surgeons
2014 Annual Meeting, the cells rescued spatial learning and memory
deficits in an animal model of Alzheimer's disease.
Additionally, Neuralstem's ability to generate human
neural stem cell lines for chemical screening has led to the
discovery and patenting of compounds that may stimulate the brain's
capacity to generate neurons, possibly reversing pathologies
associated with certain central nervous system (CNS)
conditions. The company has completed Phase Ia and Ib trials
evaluating NSI-189, its first neurogenic small molecule product
candidate, for the treatment of major depressive disorder (MDD),
and is expecting to launch a Phase II study for major depressive
disorder (MDD) in 2015. 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
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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 September 30, 2014.
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SOURCE Neuralstem, Inc.