Dr. Eva Feldman, Principal Investigator, To Update Interim Data On Neuralstem ALS Trial
Neuralstem (NYSE: CUR) announced that Eva Feldman, MD, PhD, principal investigator of the Phase I trial to test Neuralstem's human spinal cord stem cells, NSI-566, in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), will update trial data at the American Neurological Association annual meeting on Monday, October 8th (http://www.aneuroa.org/i4a/pages/index.cfm?pageid=3311). Dr. Feldman's poster presentation, "Completion and Outcomes of Phase I Intraspinal Stem Cell Transplantation Trial for ALS," will be up from 11:30-6:30. Dr. Feldman will be discussing the data between 5:30-6:30.
Dr. Feldman is the President of the American Neurological Association, as well as Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System. Dr. Feldman is an unpaid consultant to Neuralstem.
About the Trial
The Phase I trial to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients commenced in January 2010, and consisted of 18 treatments in 15 patients. The trial was designed to follow a risk escalation paradigm. The first 12 patients were each transplanted in the lumbar (lower back) region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts.
The trial then advanced to transplantation in the cervical (upper back) region of the spine. The first cohort of three was treated in the cervical region only. In an amendment to the trial design, The Food and Drug Administration (FDA) approved the return of previously-treated patients to this cohort. Consequently, the last cohort of three patients received injections in the cervical region in addition to the lumbar injections they had received earlier. All injections delivered 100,000 cells, for a dosing range of up to 1.5 million cells. The last patient was treated in August, 2012. The entire trial concludes six months after the final surgery.
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