GERMANTOWN, Md., June 25, 2014 /PRNewswire/ -- Neuralstem,
Inc. (NYSE MKT: CUR) announced that two sets of data from the
NSI-189 clinical trial in major depressive disorder (MDD) were
reported at two recent academic conferences: American Society of
Clinical Psychopharmacology (ASCP) Annual Meeting, on June 17th, and the International College of Neuropyschopharmacology
(CINP) Annual Meeting, on June 24th,
2014. NSI-189 is Neuralstem's lead proprietary neurogenic
compound. At yesterday's CINP meeting, a poster presentation on
quantitative EEG (qEEG) measurements, an electrophysical biomarker
of depression, taken during the course of study showed that
patients in the active treatment arm of the study:
- Had significantly increased brain wave patterns in the
hippocampal region of the brain. Specifically, qEEG measurements at
Day 28 showed statistical significance between the treatment and
the placebo group in the electrical wave patterns emanating from
specific areas of the brain, namely the left posterior temporal
lobe and parietal region (p<0.02).
- Showed increased electrical coherence in the prefrontal
cortical region, which is a pro-cognitive signal.
- Researchers concluded that these electrophysiological changes
are consistent with the neurogenic hypothesis of the drug
mechanism, which involves long-term structural changes in the
hippocampus.
These results follow the 28-day clinical data presented at the
ASCP meeting last week, which showed a significant and large
treatment effect in the improvement of both depression and
cognitive symptoms in the active therapy patients, compared to
placebo, which continued eight weeks after treatment stopped,
specifically:
- In a comprehensive assessment scale for depression (Symptoms of
Depression Questionnaire or SDQ), the combined treatment group
showed statistically significant improvement (p=0.02) after 28 days
of the drug treatment compared to its randomized, double-blinded,
placebo control group. There was a large effect size of
0.90.
- As measured by the assessment scale of cognitive and
functioning deficits specifically designed for depressed patients
(Cognitive and Physical Functioning Questionnaire or CPFQ), the
treatment group was significantly better than the placebo group
(p=0.01) at Day 28 with a large effect size of 0.94.
- As measured by both by SDQ and CPFQ, NSI-189's significant and
large treatment effects continued for eight weeks even after the
drug was withdrawn.
"This is a small study, but we should acknowledge the importance
of showing such a powerful signal in such a small study in an
indication with a very high placebo effect, historically," said
Richard Garr, Neuralstem's President
and CEO. "Additionally, we believe that no approved
antidepressants have shown this type of long-term disease modifying
property. If these large effect sizes and stable improvements in
both depression and cognition are replicated with larger cohorts,
we will pursue a breakthrough designation, with accelerated
development prospects and reimbursement advantages. We plan to
launch a large, multi-site Phase II study by the first quarter of
2015."
"We believe this qEEG data confirms that NSI-189 is affecting
key circuitry common in both mood control and cognition, involving
hippocampal neurogenesis and synaptogenesis," said Dr. Karl Johe, Neuralstem's Chairman and Chief
Scientific Officer. "The next clinical trial will test two doses
(40mg QD and 40mg BID), along with a randomized, double-blinded,
placebo control group, in approximately 150 patients with confirmed
diagnosis of recurrent MDD, with the aim of confirming these
extremely promising results in a larger clinical setting."
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
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.