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  • Neuralstem, Inc. (CUR) Obtains FDA Approval For Phase II Stem Cell Trial In ALS 0 comments
    Apr 18, 2013 10:28 AM | about stocks: CUR

    Today, Neuralstem announced it has received FDA approval to commence a Phase II trial using NSI-566 spinal cord-derived human neural stems cells to treat amyotrophic lateral sclerosis, commonly known as ALS or Lou Gehrig's disease. The Phase II dose escalation and safety trial will expand two centers: Emory University Hospital in Atlanta, Ga., where Phase I was recently completed; and ALS Clinic at the University of Michigan Health System in Ann Arbor, Mich. Both expansions are subject to approval by each institution's Institutional Review Board.

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

    During Phase I of the trial, it was demonstrated that the therapy appeared to interrupt progression of ALS in one subgroup of patients over a long time period. The goal of the Phase II trial is to obtain the maximum tolerated dose using the same route of administration as in the Phase I trial, which was through direct injections into the spinal cord's gray matter. Due to the excellent safety and tolerability demonstrated in the Phase I trial, Neuralstem will be able to proceed more aggressively in Phase II. The company began with just five injection sites per patient in Phase I, advancing to a minimum of 15 injections of 100,000 cells each. The company will advance up to a maximum of 40 injections in Phase II, with 400,000 cells per injection based on safety.

    Finally, Neuralstem will add another center, the University of Michigan, where the trial will be conducted under the direction of study principal investigator Dr. Eva Feldman and site investigator Dr. Parag Patil. The trial will also continue at Emory, where it originated, under the direction of site principal investigator Dr. Jonathan Glass.

    "We are eager to advance this trial to the next phase, using considerably more cells to assess the impact and safety," said Dr. Eva Feldman, MD, Ph.D., 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 serves as an unpaid consultant to Neuralstem.

    For more information about this trial, or for information about Neuralstem, visit neuralstem.com

    Please see disclaimer on the QualityStocks website: disclaimer.qualitystocks.net

    Stocks: CUR
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