ROCKVILLE, Md., April 17, 2013 /PRNewswire/ --Neuralstem,    Inc. (NYSE MKT: CUR) announced that it has received approval    from the Food and Drug Administration (FDA) to commence a Phase    II trial using NSI-566 spinal cord-derived human neural stem    cells in the treatment of amyotrophic lateral sclerosis (ALS or    Lou Gehrig's disease). This 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. 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.  
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    "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. "As a result of the    excellent safety and tolerability demonstrated in Phase I, we    will be able to proceed more aggressively in Phase II. In Phase    I, we started with just five injection sites per patient, and    advanced to a maximum of 15 injections of 100,000 cells each.    In Phase II, we will advance up to a maximum of 40 injections,    and 400,000 cells per injection based on safety.   
    "Finally, we will be adding another center, the University of    Michigan, where the trial will be under the direction of study    principal investigator, Dr. Eva Feldman, and site investigator,    Dr. Parag Patil," Dr. Johe concluded. "We are also delighted to    continue the trial where it originated, at Emory, under the    direction of site principal investigator, Dr. Jonathan Glass.    We want to thank the patients and their families who have so    bravely taken part in the trial so far and continue to support    our efforts."   
    "We are delighted to bring this trial to Michigan, where the    research for this clinical trial originated," said Eva Feldman,    MD, PhD, Director of the A. Alfred Taubman Medical Research    Institute and Director of Research of the ALS Clinic at the    University of Michigan Health System. "In Phase I, we    demonstrated that the therapy appeared to interrupt progression    of the disease in one subgroup of patients over a long period    of time. We are eager to advance this trial to the next phase,    using considerably more cells to assess the impact and safety."    Dr. Feldman is an unpaid consultant to Neuralstem.  
    "Emory is proud to have conducted the pioneering Phase I trial    where we successfully completed 18 transplants in 15 patients,    and saw that the cells and the surgical technique were    well-tolerated, and that the cells survived, long-term," said    Jonathan Glass, MD, Director of the Emory ALS Center.    "These are critical elements required for any cell    therapy to help this patient population. We are looking    forward to progressing the dosage to the maximum safe tolerated    dose, where we could also hope to see meaningful effects for    the patients."  
    About Neuralstem  
    Neuralstem's patented technology enables the ability to produce    neural stem cells of the human brain and spinal cord in    commercial quantities, and the ability to control the    differentiation of these cells constitutively into mature,    physiologically relevant human neurons and glia. Neuralstem    completed an FDA-approved Phase I safety clinical trial for    amyotrophic lateral sclerosis (ALS), often referred to as Lou    Gehrig's disease, in February 2013, and has received FDA    approval to begin Phase II. Neuralstem has been awarded orphan    status designation by the FDA for its ALS cell therapy.  
    In addition to ALS, the company is also targeting major central    nervous system conditions with its NSI-566 cell therapy    platform, including spinal cord injury, ischemic stroke and    glioblastoma (brain cancer). The company received approval to    commence a Phase I safety trial in chronic spinal cord injury    in January 2013.  
    Neuralstem also has the ability to generate stable human neural    stem cell lines suitable for the systematic screening of large    chemical libraries. Through this proprietary screening    technology, Neuralstem has discovered and patented compounds    that may stimulate the brain's capacity to generate new    neurons, possibly reversing the pathologies of some central    nervous system conditions. The company is in a Phase Ib    safety trial evaluating NSI-189, its first neurogenic small    molecule compound, for the treatment of major depressive    disorder (MDD).Additional indications could include    traumatic brain injury (TBI), Alzheimer's disease, and    post-traumatic stress disorder (PTSD).  
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Neuralstem Receives FDA Approval To Commence Phase II Stem Cell Trial In Amytrophic Lateral Sclerosis