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Thread: Clinical trial for chronics by Neuralstem

  1. #1

    Clinical trial for chronics by Neuralstem


    Richard Garr, Neuralstem’s President & CEO, said, “2010 continues to be a year of major milestones for Neuralstem. We started by moving into the clinic to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's disease) with our spinal cord neural stem cell therapy. We also completed the necessary financings to fund our transition from the laboratory into the clinic for multiple trials that we expect to start in the balance of the year. Towards that end, we expect to file an IND for a Phase I safety trial for chronic spinal cord injury with the FDA later this month. We also expect to file an IND for a Phase I safety trial for major depression for our small molecule drug in the fourth quarter.”
    Clinical Program and Business Highlights
    In May 2010, Neuralstem’s President & CEO, Richard Garr, presented at the Fifth Annual World Stem Cells and Regenerative Medicine Congress, in London, UK. Mr. Garr's presentation "Goals, Challenges and Solutions for Bringing Cell-Based ALS Therapy to the Clinic" addressed the goals and scientific potential of applying cell therapy to ALS, as well as the challenges and solutions in bringing this treatment to patients.
    The company also announced that, after reviewing the safety data from the first cohort of 3 patients, the independent Safety Monitoring Board overseeing the ALS trial gave the approval to move to the second cohort of 3 patients, which took place over the third quarter. The first cohort of 3 patients received only 5 injections each, unilaterally. The second cohort of patients received 10 injections each, bilaterally, in the lower spinal cord. Subject to review of the first two cohorts and approval by the Safety Monitoring Board, the next part of the trial will move into earlier-stage ALS patients in October.
    In June 2010, the Principal Investigator of Neuralstem’s Phase I clinical trial to treat ALS with its spinal cord stem cells, Dr. Eva Feldman, presented at the inaugural A. Alfred Taubman Forum on Improving Science and Technology Innovation in the United States, at The Brookings Institution in Washington, D.C. Dr. Feldman, PhD, MD, is the Russell DeJong Professor of Neurology and Director of the ALS Clinic at the University of Michigan. Dr. Feldman's talk addressed the importance of medical research at academic centers to keep America at the forefront of innovation, of which the ALS trial is an example. As part of the talk, Dr. Feldman discussed some general aspects of the ALS trial.
    In June 2010, Neuralstem completed a financing via a registered direct offering of $10 million of units to institutional investors and provided updates on its BioTherapeutics, BioPharmaceuticals and International initiatives:
    BioTherapeutics: Neuralstem announced that it will submit a clinical trial application in chronic spinal cord injury to the FDA as the first of planned additional FDA clinical trial submissions utilizing the company’s neural stem therapy platform. The company is on schedule to file an Investigational New Drug (IND) submission with the FDA this month. The Phase I clinical trial for chronic spinal cord injury is planned to be a multisite study.
    BioPharmaceuticals: Four Neuralstem molecules have demonstrated neurogenic activity, the ability to stimulate neurogenesis of normal adult brain cells in the hippocampus. Neuralstem scientists have been developing this new class of drugs over the past 12 months. They are currently completing the pre-clinical pharmaceutical programs to submit INDs to the FDA for Phase I clinical trials for the company’s first-in-class neurogenic small molecule drug. The first Phase I trial of Neuralstem’s small molecule compound is expected by early 2011, with an initial trial indication of major depression. Neuralstem believes that its ability to screen against its proprietary cells provides a valuable and unique advantage for the discovery of novel compounds to central nervous system (CNS) diseases. As such, this first small molecule drug program will be a powerful validation of its screening platform.
    International Initiatives: Neuralste

  2. #2
    Yes ! keep`t coming
    keep (rolling) Walking

    Please join me and donate a dollar a day at and copy and paste this message to the bottom of your signature

  3. #3

  4. #4
    Dr. Young
    Can you tell us something about thiere pre clinical studies?

  5. #5
    this is good news, the first trial for chronic, without asking for donation.

  6. #6
    For those that follow the market impact of this....

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