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SOURCE Neuralstem, Inc.
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.
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).
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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