BOSTON, MA--(Marketwire -06/25/12)- When it comes to disease, few are crueler than ALS. Approximately 5,600 people in the U.S. are diagnosed with ALS each year. Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. The motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. The progressive degeneration of the motor neurons in ALS eventually leads to their death. The life expectancy is 2-5 years from the time of diagnosis. When the motor neurons die, the ability of the brain to initiate and control muscle movement is lost. Most ALS patients expire from suffocation while suffering no cognitive depreciation.
Brainstorm Cell Therapeutics Inc., trading on the Over the Counter Bulletin Board in the United States, is leading the fight to finding a cure for ALS with its NurOwn proprietary technology. The NurOwn technology is changing the field of regenerative medicine by reprogramming bone marrow derived from mesenchymal stem cells into neuron-supporting cells. The axon terminals (nerve cells ending) will take up neurotrophic factors secreted by the transplanted cells into the muscles or the spinal cord and transport them back into cell bodies within the spinal cord. This will prevent further degeneration of the neuronal cells. Although the primary purpose of the Phase I/II trial being conducted at the prestigious Hadassah Medical Center in Jerusalem is to ensure safety and tolerability, initial data has shown efficacy. Professor Eldad Melamed, the lead investigator of the trial, said, "There have been no significant side effects in the initial patients we have treated with BrainStorm's NurOwn technology. In addition, even though we are conducting a safety trial, the early clinical follow up of the patients treated with the stem cells shows indications of beneficial clinical effects, such as an improvement in breathing and swallowing ability as well as in muscular power. I am very excited about the safety results, as well as these indications of efficacy, we are seeing. This may represent the biggest hope in this field of degenerative diseases, like ALS." Dr. Adrian Harel, CEO of Brainstorm, indicated trial data from the first cohort of 12 patients with ALS will be made available to the public sometime in July 2012.
Sai Rosen, Director for Stem Cell Media, LLC, observed, "Brainstorm's early clinical results showed a marked improvement in breathing. An arterial blood gas (ABG) test measures the levels of oxygen and carbon dioxide in the blood to determine how well the lungs are working and according to the initial data the patients showed improved ABG."
It is expected that a Phase II/III ALS trial application will be filed with the FDA in the United States in the second half of 2012. Brainstorm recently received FDA Orphan Drug Designation for its NurOwn cell therapy for ALS in the U.S. The trial site in the U.S. will be conducted at Massachusetts General Hospital (MGH) and is expected to begin late 2012.
The Company is well positioned financially to see the ALS trial through proof of concept. Dr. Harel has arranged a $10MM stock purchase agreement along with non-dilutive grant monies from the Office of the Chief Scientist (OCS) in the amount of approximately $350,000. The yearly grant for 2012 is $1,100,000 (~4.2 M NIS). Dr. Harel commented, "We are thankful to the OCS for its continued support of our Research and Development program. The non-dilutive capital that we are receiving from the OCS will help move forward our NurOwn technology as a potential new treatment standard for patients with Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS)."
Brainstorm's flagship NurOwn technology is also being applied to adult stem cell therapies to treat a variety of debilitating neurodegenerative diseases, such as Parkinson's Disease (PD), Multiple Sclerosis (MS) and spinal cord injuries.
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From the Hands of Angels: Brainstorm Cell Therapeutics Inc.