ROCKVILLE, Md., May 10, 2011 /PRNewswire/ --Neuralstem, Inc. (NYSEAmex: CUR) reported its financial results for the three months period ended March 31, 2011 and provided a business and clinical update.
"The Company reached several major milestones in the first Quarter of 2011. Interim data from our Phase I trial for ALS was presented at the American Academy of Neurology Annual Meeting in April, where the principal investigator of the trial, Dr. Eva Feldman, reported the ground-breaking work was both feasible and safe," said Neuralstem's Chairman and Chief Scientific Officer Karl Johe, PhD. "We completed all of the transplantations for the first 12-patient cohort in our ALS trial in mid-April. Also, in February, the U.S. FDA Office of Orphan Products Development granted the Company orphan drug designation for the cell therapy treatment of ALS with its human spinal cord-derived neural stem cells (NSI-566RSC)."
"Further, after receiving approval from the FDA late in 2010 for our first small molecule drug trial, NSI-189 for major depression, we began dosing in our phase 1a patients in February," said Dr. Johe. "Looking forward, we expect the FDA to approve the second part of the Phase I ALS trial this summer. The next group of patients will receive injections in the upper spinal cord area, where we believe that the injections can ultimately aid in the preservation of respiratory capacity for ALS patients. Additionally, we expect the NSI-189 major depression trial to proceed to Phase Ib with escalating dosing of depressed patients this summer. The small molecule program has been strengthened by the addition of Maurizio Fava, MD, Director of the Massachusetts General Hospital Department of Psychiatry Clinical Trials Network and Institute, who is now consulting on the trial des
|SOURCE Neuralstem, Inc.|
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