GERMANTOWN, Md., May 23, 2014 /PRNewswire/ -- Neuralstem,
Inc. (NYSE MKT: CUR) announced that data from the NSI-189 Phase Ib
study in major depressive disorder (MDD) will be presented at the
American Society of Clinical Psychopharmacology Annual Meeting in
Hollywood, Florida, on
June 17th at 4:15 EDT. NSI-189 is Neuralstem's first-in-class,
lead neurogenic small molecule compound. In pre-clinical studies,
NSI-189 was shown to promote the formation of new neurons
(neurogenesis) in animals and in human hippocampus-derived neural
stem cells. In "A Phase Ib Randomized, Double-Blind,
Placebo-Controlled, Multiple-Dose Escalation Study Evaluating the
Effects of NSI-189 Phosphate, A Neurogenic Compound, in Patients
with Major Depressive Disorder (MDD)," found on page 73 of the
abstract book
http://ascpmeeting.org/wp-content/uploads/2014/05/ASCP-Oral-Abstract-Book-Online.pdf,
study author, Marlene Freeman, MD,
Medical Director, Clinical Trials Network and Institute,
Massachusetts General Hospital, and Associate Professor of
Psychiatry, Harvard Medical School,
will discuss trial results, including that depressed patients on
two different doses showed clinically meaningful reductions in
depressive and cognitive symptoms across all measures against
placebo. Furthermore, these improvements appeared to persist
throughout the follow up period. Based on the results, the
investigators, including lead study author, Maurizio Fava, MD, Executive Vice Chair,
Department of Psychiatry, Executive Director, Clinical Trials
Network and Institute, Massachusetts General Hospital, concluded
that a neurogenesis-based platform could identify promising new
treatments for major depressive disorder.
"We are honored that the highly prestigious American Society of
Clinical Psychopharmacology selected our data for presentation at
their Annual Meeting," said Karl
Johe, PhD, Neuralstem's Chairman and Chief Scientific
Officer. "This is extremely robust Phase Ib data. As the
abstract points out, trial patients on active therapy
experienced meaningful reductions in their depressive and cognitive
symptoms across all clinical measurements, including the
Montgomery-Asberg Depression Rating Scale (MADRS); the Clinician
Global Impression – Improvement (CGI-I); the Symptoms of Depression
Questionnaire (SDQ) and the Cognitive and Physical Functioning
Questionnaire (CPFQ). We are eager to share the complete data in
the June 17th presentation, as well
as biomarker data from trial, which will be presented at the
International College of
Neuropsychopharmacology World Congress in Vancouver on June
24th."
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.