Navigation Links
Neuralstem Receives FDA Orphan Designation for Spinal Cord Stem Cells for Treatment of ALS
Date:2/9/2011

ROCKVILLE, Md., Feb. 9, 2011 /PRNewswire/ -- Neuralstem, Inc. (NYSE Amex: CUR) announced that the U.S. Food and Drug Administration's Office of Orphan Products Development has granted it orphan drug designation for the treatment of Amyotrophic Lateral Sclerosis (ALS) with its human spinal cord derived neural stem cells (NSI-566RSC), currently in a Phase I safety study to evaluate the safety of the product and the surgical route of administration in a wide range of ALS patients.

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

"Congress passed the Orphan Drug Act because it recognized that adequate drugs for many rare diseases have not been developed," said Richard Garr, president and CEO of Neuralstem. "The designation of our spinal cord stem cells as an orphan drug underscores the importance of developing effective treatments for patients with ALS. In addition to providing a seven-year term of market exclusivity for our stem cells for ALS upon FDA approval, Orphan Drug Designation also positions Neuralstem to take advantage of certain financial and regulatory benefits, including government grants for conducting clinical trials, waiver of FDA user fees for the submission of a Biologics License Application for NSI-566RSC, and certain tax credits. It is an important step forward for the company."

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 in a FDA-approved Phase I safety clinical trial for Amyotrophic Lateral Sclerosis (ALS), often referred to as Lou Gehrig's disease.

In addition to ALS, the company is also targeting major central nervous system diseases, including traumatic spinal cord injury, ischemic spastic paraplegia, and Huntington's disease. The company has also 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. The company has been approved to commence a Phase Ia safety trial evaluating NSI-189, its first small molecule compound, for the treatment of major depression.  Additional indications could include schizophrenia, Alzheimer's disease, traumatic brain injury, posttraumatic stress syndrome, and stroke.

For more information, please go to 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, 2009, and in its quarterly report on Form 10-Q for the period ended September 30, 2010.


'/>"/>
SOURCE Neuralstem, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Neuralstem Receives FDA Approval to Commence Drug Trial for Major Depression
2. Neuralstems Human Stem Cells Integrate into Nervous System of Rats with Animal Model of ALS
3. Neuralstems ALS Trial on Clinical Hold
4. Neuralstem Licenses Cleveland Clinic Spinal Cord Injection Technology
5. Neuralstem Announces Issuance of Core Technology Patent in Europe
6. Rcadia COR Analyzer System Receives Expanded FDA Clearance to Rule Out Coronary Artery Disease in Coronary Branch Vessels
7. Access Pharmaceuticals Receives Early MuGard Prescriber Anecdotal Feedback Validating Larger Target Market Potential
8. Covaris Receives the Society for Laboratory Automation and Screening (SLAS) New Product Award at LabAutomation 2011
9. Actavis Receives Approval of Pantoprazole Sodium Delayed-Release Tablets, USP in the U.S.
10. The Villages Charter School Receives Donation From Praxis EMR
11. Pervasis Receives FDA Fast Track Status for Vascugel® to Prevent Arteriovenous Access Failure in Patients Undergoing Hemodialysis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Dublin - ... " Global Markets for Spectroscopy Equipment" report ... This report focuses on the global market of ... applications in various applications. The report deals with spectroscopy ... industries: pharmaceutical and biotechnology, food and beverage, and environmental ...
(Date:6/24/2016)... Research and Markets has announced the ... Tests" report to their offering. ... The World Market for Companion Diagnostics covers the ... analysis in the report includes the following: ... Kits) by Region (N. America, EU, ROW), 2015-2020 , ...
(Date:6/23/2016)... HOUSTON , June 23, 2016  MedSource ... platform as its e-clinical software solution of choice.  ... the best possible value to their clients by ... nowEDC.  The preferred relationship establishes nowEDC as the ... pricing for MedSource,s full-service clients.  "nowEDC has long ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements ... that was developed to enhance the health of felines. The formula is all-natural and ... main herbs in the PawPaws Cat Kidney Support Supplement Soft Chews are ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... Austin ... of the American College of Mohs Surgery and to Dr. Russell Peckham for medical ... and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe ... from the David Geffen School of Medicine at UCLA. He trained in Internal Medicine ... his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... A recent ... that most people are unfamiliar with. The article goes on to state that individuals ... also many of these less common operations such as calf and cheek reduction. The ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association (PHA) ... will receive two significant new grants to support its work to advance research ... anniversary by recognizing patients, medical professionals and scientists for their work in fighting ...
Breaking Medicine News(10 mins):