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Neuralstem Announces 2012 Financial Results, Provides Clinical Trials Update
Date:3/15/2013

Symposium on ALS/MND in December (2012) showed evidence of long-term NSI-566 cell survival in patients, through DNA fingerprinting. It was further announced that the study team has received a grant from the National Institutes of Health (NIH) to cover a majority of the cost of an upcoming NSI-566/ALS Phase II trial. In October, Eva Feldman , M.D., Ph.D., the trial's principal investigator and Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System, presented updated data at the American Neurological Association (ANA) annual meeting. Dr. Feldman, who is president of the ANA, presented interim results on all 18 procedures in 15 patients, and said, "...we are exploring a paradigm shift in the treatment of ALS. ...Although this phase of the trial was not powered to demonstrate efficacy, we appear to have interrupted the progression of the disease in one subgroup of patients." The Phase I NSI-566/ALS safety trial consisted of 18 treatments in 15 patients, at Emory University Hospital. All injections delivered 100,000 cells, for a dosing range of up to 1.5 million cells. In February, Patient 14 was the second patient to be dosed in the cervical (upper back) region where the cells could support breathing, the key function that is lost as ALS progresses. In May, the FDA approved additional NSI-566 dosing of patients who had previously received lumbar injections, to return for cervical injections as the trial's final cohort; the FDA-approved trial amendment was subsequently approved by the Emory University Institutional Review Board in June. Additionally, Neuralstem had submitted a trial amendment to the FDA to increase both the number of patients treated as well as the dose in future cohorts, which was then withdrawn and modified to become the Phase II protocol. The entire Phase I ALS trial officially concluded in February 2013, six months after the fina
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