Navigation Links
Neuralstem's ALS Trial on Clinical Hold
Date:2/20/2009

ROCKVILLE, Md., Feb. 20 /PRNewswire-FirstCall/ -- Neuralstem, Inc. (NYSE Alternext US: CUR) announced today its spinal cord stem cell trial to treat ALS is on clinical hold and that the Federal Drug Administration (FDA) has provided the Company with specific comments, questions and recommendations for modifications to its protocol.

(Logo: http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO )

"The FDA has presented us with their review of our entire Investigational New Drug (IND) application," said Richard Garr, Neuralstem's President & CEO. "They have asked for some additional information regarding our product manufacturing process and pre-clinical studies, as well as our novel clinical delivery injection device and technique. The Company believes that it can provide this information in an expeditious manner."

"The Agency has also requested various modifications to the protocol and eligibility criteria for patients in the trial, as well as slight changes to the timing of the surgeries," Mr. Garr continued. "We are evaluating these changes and will respond accordingly. The Agency had extensive 'non hold' comments, requests for information, and recommendations. These primarily concerned issues that will need to be addressed for final product manufacturing and testing. We are appreciative of their work in this area."

"Over all we believe the Agency's comments and recommendations are extremely helpful," Garr concluded. "We are evaluating them carefully, and expect to reach agreement with the Agency on all matters so that the trial can be approved and move forward."

About Neuralstem

Neuralstem's patented technology enables, for the first time, 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 into mature, physiologically relevant human neurons and glia. Major Central Nervous System diseases targeted by the Company with research programs currently underway include: Ischemic Spastic Paraplegia, Traumatic Spinal Cord Injury, Huntington's disease and Amyotrophic Lateral Sclerosis (ALS).

In pre-clinical work, the company's cells have extended the life of rats with ALS (Lou Gehrig's disease) as reported the journal TRANSPLANTATION, in collaboration with Johns Hopkins University researchers, and also reversed paralysis in rats with Ischemic Spastic Paraplegia, as reported in NEUROSCIENCE on June 29, 2007, in collaboration with researchers at University of California San Diego.

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- KSB for the year ended December 31, 2007 and the quarterly report on form 10-Q for the period ended September 30, 2008.


'/>"/>
SOURCE Neuralstem, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Progen Engages Leading CRO to Assist with Phase 3 Trial of PI-88
2. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
3. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
4. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
5. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
6. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
7. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
8. Clinical Trial Effectiveness: How Pharmas & Biotechs Save Cost with Savvy Investigator Management
9. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
10. Iomai Trial Shows 100 Percent Immune Response in Elderly Subjects Vaccinated With Novel Travelers Diarrhea Patch Vaccine
11. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... Texas , Dec. 8, 2016 ... program that brings leading-edge laboratory services and management ... United States , allowing more doctors and ... health care management solutions. Logo - ... Hospital systems, under pressure to contain ...
(Date:12/8/2016)... 8, 2016 Information products and services provider ... in Scopus , the world,s largest abstract and citation database ... metrics for journals from over 5,000 publishers. The new set of ... subscribe to and when to adjust a journal,s editorial strategy. ... , , ...
(Date:12/8/2016)... A Small Business Innovative Research (SBIR) grant has been ... Phoenix -based NeuroEM Therapeutics, Inc. and ... seek to determine an optimal set of treatment parameters ... treat Alzheimer,s Disease. The grant will also investigate the ... neurologic disorders such as Parkinson,s Disease and PTSD. ...
Breaking Medicine Technology:
(Date:12/9/2016)... (PRWEB) , ... December 09, 2016 , ... Mediaplanet today ... for organ transplantation while encouraging readers to sign up as an organ donor for ... organ transplant. , An organ donor can save up to 8 saves through ...
(Date:12/9/2016)... PA (PRWEB) , ... December 09, 2016 , ... ... education program through the Pennsylvania Cable Network (PCN) during the summer of 2016. ... Injury Implementation Grant provided by the United States Department of Health and Human ...
(Date:12/8/2016)... ... December 08, 2016 , ... Russ DiGilio ... the first national #QuackGivesBack campaign which supported local breast cancer organizations during National ... Quack Gives Back initiative, and we’re very pleased with the participation ...
(Date:12/8/2016)... ... ... CURE Media Group, the nation’s leading digital and print media enterprise focused ... in efforts to combat lung cancer, announced CURE Media Group President Michael J. Hennessy, ... is honored to team up with Upstage Lung Cancer in order to make major ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... for customers and employees that are both engaging and easy to use. Coming ... Technology, the software company revealed today its plans to roll out new AI-powered ...
Breaking Medicine News(10 mins):