ALS Patient Responds to BrainStorm Stem Cells
Israeli Channel 2 TV interviewed a patient suffering from Myasthenia Gravis (MG) and recently diagnosed with ALS. The patient reported that he has experienced visible improvement in his speech, walking, balance, posture, muscle strength, appetite, digestion, and weight gain following compassionate treatment with BrainStorm’s NurOwn cell therapy. “Due to the rare disease combination of MG and ALS, this patient was approved for compassionate treatment with BrainStorm’s NurOwn cell therapy” says Professor Dimitrios Karussis of the Neurology Department at The Hadassah Medical Center in Jerusalem, and Principal Investigator of BrainStorm’s current Phase I/II clinical trial. “Within a few weeks following injection with NurOwn cells, the patient showed dramatic improvement in a variety of functions including breathing, speech, walking, muscular strength, and overall well-being. While we cannot draw scientific conclusions based on the outcome of an individual patient, these results are extremely encouraging.” In January 2012 BrainStorm reported initial safety data from the first four patients in BrainStorm’s ALS Phase I/II human clinical trial, indicating that treatment with NurOwn did not present any significant side effects and demonstrated some beneficial clinical effects. After reviewing this safety data, the Hadassah Medical Center ethical committee granted approval for the trial to continue. Interim results for the first 12 patients are expected in July 2012. BrainStorm expects to expand its ALS clinical development into the United States. Orphan-drug designation for NurOwn has been granted by the US Food and Drug Administration. In addition, 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.