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Neuralstem Receives FDA Approval to Dose Patients in Cervical Region in Ongoing ALS Trial
Date:10/24/2011

ROCKVILLE, Md., Oct. 24, 2011 /PRNewswire/ -- Neuralstem, Inc. (NYSE Amex: CUR) updated the progress of its ongoing Phase I safety trial of the company's spinal cord stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) at Emory University in Atlanta, Georgia. The company announced that, after reviewing safety data from the first 12 patients, the Food and Drug Administration (FDA) has granted approval for the trial to advance to transplanting patients in the cervical (upper back) region. Until now, patients have received injections in the lumbar (lower back) region only.  Earlier this summer, the trial's Safety Monitoring Board unanimously approved moving to the cervical injection phase. The trial will now advance to the final two cohorts of patients with ALS, all of whom will be transplanted in the cervical region of the spine.

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"The goal of our cell therapy program is to create therapies that will slow down, stabilize, or  reverse, functional deficits in central nervous system (CNS) diseases," said Karl Johe, PhD, Neuralstem Chairman and Chief Scientific Officer. "By moving the cell delivery to cervical spinal cord—the first time the FDA has approved intraspinal injections in this region—we will demonstrate that we can deliver our cells safely and routinely to all parts of the spinal cord."

The trial is under the direction of Principal Investigator, Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System, and Jonathan D. Glass, MD, Director of the Emory ALS Center. The surgeries are performed by Emory Neurosurgeon, Nicholas M. Boulis, MD. Dr. Feldman is an unpaid consultant to Neuralstem.

In a joint statement, the three do
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SOURCE Neuralstem, Inc.
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