ROCKVILLE, Md., Oct 27, 2011 /PRNewswire/ -- Neuralstem, Inc. (NYSE Amex: CUR) announced that it has completed Phase Ia in the ongoing safety trial to test its neuroregenerative small molecule drug, NSI-189, in the treatment of major depressive disorder (MDD). Phase Ia tested the drug in healthy volunteers for safety and tolerability. Phase Ib, which the company expects to commence later this year, will test the safety and tolerability of NSI-189 in depressed patients.
NSI-189 is a proprietary new chemical entity discovered by Neuralstem that stimulates new neuron growth in the hippocampus, an area of the brain that is believed to be involved in MDD and other diseases and conditions, such as Alzheimer's disease and post-traumatic stress disorder (PTSD).
"We are extremely pleased the trial has progressed so smoothly," said Karl Johe, PhD, Chief Scientific Officer and Chairman of Neuralstem's Board of Directors. "We didn't see any drug-related adverse effects in this set of patients. We are eager to move to the next phase of this safety trial, where we will be testing NSI-189 in patients who suffer from major depressive disorder."
About the Trial
This Phase Ia trial tested single ascending doses of NSI-189 in healthy patients. Standard safety endpoints were monitored. All doses were well tolerated and there were no drug-related serious adverse events. The trial will commence to the Ib phase, testing the safety of escalating doses of daily administration for 28 days in depressed patients. The entire Phase I trial is expected to be approximately one year in duration.
NSI-189 is the lead compound in Neuralstem's neurogenerative small molecule drug platform, which the company plans to develop into orally administered drugs for major depression and other psychiatric disorders.
NSI-189 stimulated neurogenesis of human hippocampus-derived neural stem cells in- vitro. In mice, NSI-189 stimulated neurogenesis in the hippocampus and increased its volume. In humans, NSI-189 may reverse the human hippocampal atrophy seen in major depression and other disorders. This program has received significant support from both the Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH).
Neuralstem's patented technology enables the ability to produce neural stem cells of the human 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 glia. Neuralstem is conducting an ongoing FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.
In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia, chronic stroke, and Huntington's disease. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.
Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the 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 new neurons, possibly reversing the pathologies of some central nervous system conditions. Neuralstem's first small molecule compound, NSI-189 is currently in a Phase I FDA-approved safety trial in major depressive disorder. The Phase Ib portion of the trial, in depressed patients, is expected to commence later this year. Additional indications could include schizophrenia, Alzheimer's disease and bipolar disorder.
For up-to-date information on the clinical trials for NSI-189/MDD, ALS and other Neuralstem cell therapy and pharmaceutical treatments in development, visit www.neuralstem.com
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, 2010 and the quarterly report on Form 10-Q for the period ended June 30, 2011.
|SOURCE Neuralstem, Inc.|
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