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Neuralstem Obtains FDA Approval To Begin Phase II Stem Cell Trial In ALS

Neuralstem Inc. (CUR) announced Wednesday that it has received approval from the Food and Drug Administration or FDA to commence a Phase II trial using NSI-566 spinal cord-derived human neural stem cells in the treatment of amyotrophic lateral sclerosis or ALS or Lou Gehrig's disease.

The company noted that the Phase II dose escalation and safety trial will expand to two centers, Emory University Hospital in Atlanta, Georgia, where Phase I was recently completed, and ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan, subject to approval by the Institutional Review Board at each institution.

According to the company, The trial is designed to treat up to 15 patients, in five different dosing cohorts. All of the patients will be ambulatory and reside within close geographic proximity to the research center where they will participate. The first 12 patients will receive injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function. The final three patients will receive both cervical and lumbar injections.

"The aim of this Phase II trial is to obtain the maximum tolerated dose using the same route of administration as in Phase I, which was through direct injections into the gray matter of the spinal cord," said Karl Johe, PhD, Neuralstem Chairman and Chief Scientific Officer.

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