Navigation Links
Neuralstem Completes Phase Ia in Neuroregenerative Small Molecule Drug, NSI-189, Major Depressive Disorder Trial
Date:10/27/2011

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.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO)

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.

About NSI-189

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).

About Neuralstem

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.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Neuralstem Announces Issuance of Core Technology Patent in Europe
2. Neuralstem Licenses Cleveland Clinic Spinal Cord Injection Technology
3. Neuralstems ALS Trial on Clinical Hold
4. Neuralstems Human Stem Cells Integrate into Nervous System of Rats with Animal Model of ALS
5. Neuralstem Receives FDA Approval to Commence Drug Trial for Major Depression
6. Neuralstem Receives FDA Orphan Designation for Spinal Cord Stem Cells for Treatment of ALS
7. Neuralstem Updates ALS Clinical Trial Progress
8. Dr. Eva Feldman, Principal Investigator, Presents Interim Safety Results for Neuralstem ALS Trial
9. Neuralstem Updates NSI-189 Major Depression Trial
10. Neuralstem Announces Notice of Allowance for Two Additional Neurogenic Compound Patents
11. Dr. Eva Feldman, Principal Investigator, Presents Interim Data on Neuralstem ALS Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... , Oct. 12, 2017   Divoti USA ... Jewelry up to the standard of the latest FDA requirements, which ... 2017). Anyone in need of Medical ID jewelry such ... Alert Jewelry are engraved in terms of the new ... Divoti offers ...
(Date:10/11/2017)... , Oct. 11, 2017  True Health, a ... amplified its effort during National Breast Cancer Awareness ... cancer risks. ... Oncology calculated that more than 10 million American ... mutations in BRCA1 or BRCA2 and have not had ...
(Date:10/7/2017)... --  Provista, a proven leader in the supply ... power, today announced a new resource area on Provistaco.com ... is the online home for case studies, articles on ... releases, slideshows and events. ... at their fingertips, viewers can also watch short videos ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 13, 2017 , ... Ellevate Network, the leading network for professional women, brought ... gender equality at their inaugural Summit in New York City in June. The event ... audience of over 3 million. To watch the Mobilize Women video, click here ...
(Date:10/13/2017)... VA (PRWEB) , ... October 13, 2017 , ... ... of DevOps and Agile Software Development, has been awarded a contract by the ... Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San Francisco ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are estimated ... in breathing. Oral appliances can offer significant relief to about 75 percent of ...
(Date:10/12/2017)... , ... October 12, 2017 , ... The American College ... to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium in ... , In honor of Morris F. Collen, a pioneer in the field of medical ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader in ... 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced ... 2017. , The annual award competition recognizes editorial and design excellence across a range ...
Breaking Medicine News(10 mins):