Will Present Final ALS Phase I Results Including New Cervical Cohort Data
ROCKVILLE, Md., June 10, 2013 /CNW/ - Neuralstem, Inc. (NYSE MKT: CUR) today reported that Eva Feldman, MD, PhD, will address the Canadian Neurological Sciences Federation Annual Congress, in Montreal, Canada, on Thursday, June 13th at 8:30 a.m. ET as a grand plenary speaker (http://congress.cnsfederation.org/). Dr. Feldman will present final data from Neuralstem's Phase I trial testing NSI-566 spinal cord-derived neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). Adding to her presentation at a medical conference last month in Romania, Dr. Feldman will discuss new data from the patient cohorts treated in the cervical region.
Dr. Feldman is the principal investigator for the trial, which was recently approved by the FDA to commence to Phase II. She is also Director of the A. Alfred Taubman Medical Research Institute, Director of Research of the ALS Clinic at the University of Michigan Health System and the President of the American Neurological Association. Dr. Feldman is an unpaid consultant to 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 completed an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, in February 2013, and has received FDA approval to begin Phase II. 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, ischemic stroke and glioblastoma (brain cancer). The company received approval to commence a Phase I safety trial in chronic spinal cord injury in January 2013.
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 is in the last cohort of a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could 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, 2012 and the Form 10-Q for the period ended March 30, 2013.
SOURCE: Neuralstem, Inc.
For further information:
Deanne Eagle - Media Relations, 917.837.5866; Susan Roush - Investor Relations, 818.222.8330
PRN Photo Desk, [email protected]