In January we reported on an Israeli biotechnology company, BrainStorm, which announced successful results in its clinical trial for a treatment against ALS (Amyotrophic Lateral Sclerosis) – a fatal neurodegenerative disease also known as Lou Gehrig’s disease.
Less than six months later, Israeli Channel Two audiences last night were moved to see an ailing rabbi, who had been diagnosed with ALS, able to walk and talk again after being treated with Brainstorm‘s ‘NurOwn.’
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Patients are transplanted with stem cells derived from their own bone marrow and then treated with the NurOwn stem cell technology.
Rabbi Refael Shmulevitz was diagnosed with ALS four months ago and given two to four years to live. He lost the ability to talk clearly and was confined to a wheelchair.
“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,” said 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.
“While we cannot draw scientific conclusions based on the outcome of an individual patient, these results are extremely encouraging,” he added.
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“We are moved by the remarkable results observed following treatment with NurOwn,” said Professor Avi Israeli, BrainStorm’s Chairman of the Board. “We are hopeful that we will continue to see this kind of improvement in all the patients participating in our current and future clinical trials.”
In January 2012 the Company 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.
Expanding to the Unites States
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.
Dr. Adrian Harel, acting CEO and director of R&D at BrainStorm, told NoCamels that in the future “it will hopefully be possible to treat Parkinson’s disease as well as Huntington’s and other nerve diseases.”
Image courtesy of Channel Two