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News Breaks | | | | July 23, 2012 | | 05:32 EDT |  | BCLI | BrainStorm Cell reports outstanding ALS interim clinical trial results
BrainStorm Cell Therapeutics announced that it has completed the planned interim safety review of its Phase I/II ALS, or Amyotrophic Lateral Sclerosis, clinical trial, indicating that autologous transplantation of the company's cell therapy was well-tolerated, appears to be safe for use, and did not present any undue risks to the study participants. The company is also happy to report that in some patients this pilot study demonstrated a tendency toward stabilization in some parameters in the ALS Functional Rating Scale. The company submitted the positive interim safety report to the Israeli Ministry of Health. The interim data was reported on the first group of patients, all of whom suffer from early stage or progressive ALS, also known as Lou Gehrig's disease. All patients enrolled were transplanted with NurOwn either intramuscularly or intrathecally. Orphan-drug designation for NurOwn has been granted by the U.S. FDA, and BrainStorm is awaiting FDA approval to expand its ALS clinical development to the U.S. The company has entered into a Memorandum of Understanding with the University of Massachusetts Medical School and Massachusetts General Hospital to begin ALS human clinical trials at these institutions. | |
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