Brainstorm (OTC BCLI) A P1/2 ALS Safety trial
The purpose of the P1/2 trial is to ensure safety and tolerability, initial data has shown efficacy with its NurOwn(TM) technology.
The NurOwn(TM) technology is 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. The P1 will be conducted at the prestigious Hadassah Medical Center in Jerusalem. A P2/3 ALS trial application will be filed with the FDA in the US in the Q3-4/12. BCLI recently received FDA Orphan Drug Designation for its NurOwn(TM) cell therapy for ALS in the US. The trial will be conducted at Massachusetts General Hospital (MGH) and is expected to begin late 2012.
The Bottom Line: BCLI is conducting a … safety trial, as the early clinical follow up of the patients treated with the stem cells showed indications of beneficial clinical effects, such as an improvement in breathing and swallowing ability as well as in muscular power.
Approximately 5,600 people in the US 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.
BCLI was up $0.053 to $0.33 or 19.13% on 7.2.12