Last week a U.S. company announced initial Phase I/II clinical trial results for ALS (Amyotrophic Lateral Sclerosis)
Online PR News – 24-January-2012 – In the quest to find treatments for certain neurological diseases, BrainStorm is fast distinguishing itself as a leader in the field of regenerative medicine using stem cells through its unique platform called NurOwn. The Company can process human mesenchymal stem cells, which are present in bone marrow and are capable of self-renewal as well as differentiation into many other tissues. What makes BrainStorm technology platform very attractive to Big Pharma partnering is the autologous nature of the bone marrow-derived stem cells. This will in turn drastically reduce the expected translation time to market. The value of a treatment for ALS in the U.S. and EU is estimated to be $4Billion. The potential applications for the NurOwn platform to treat disease is fast becoming a reality. In short, BrainStorm is leveraging a patients own cells to heal itself of disease.
BrainStorm updated stakeholders recently with a review of the trial six months post transplantation. The Phase I/II clinical trial for ALS is being conducted at the prestigious Hadassah Medical Center in Jerusalem by renowned Professor Dimitrios Karussis, M.D., Ph.D. and a distinguished scientific team in its own right from BrainStorm headed by Professor Eldad Melamed. Patients have been transplanted with stem cells derived from their own bone marrow and treated with BrainStorm's NurOwn stem cell technology. The trial will include a total of 24 patients, 12 in an advanced stage of the disease and 12 in an early stage.
The staff at Stem Cell Media and www.InvestorStemCell.com has initiated broad investor awareness coverage after Dr. Dimitrios Karussis announced early indications of efficacy last week. Dr. Karussis said, There have been no significant side effects in the initial patients we have treated with BrainStorms 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.
BrainStorms ALS trial is coming to the United States sometime in 2012. After receiving Orphan Drug Designation for its NurOwn cell therapy for ALS in the US, BrainStorm is planning to carry out its Phase II clinical trials in the US. To that end, BrainStorm Cell Therapeutics is currently working with the Northeast ALS consortium to design a phase II trial in the United States and has signed a Memorandum of Understating with the Massachusetts General Hospital and the University of Massachusetts Medical School in anticipation of applying for FDA approval to begin ALS human clinical trials in the United States in the course of 2012. The University of Massachusetts Medical School team will be led by Professor Robert H. Brown, MD, DPHIL., and Chair of the Neurological Department at University of Massachusetts Medical School. Professor Brown is a leading expert in neuromuscular genetics and is world renowned for his expertise in ALS. Professor Merit Cudkowitz will lead the Massachusetts General Hospital team.
About BrainStorm (OTC.BB:BCLI) is a leading developer of stem cell technologies to provide treatments for currently incurable neurodegenerative diseases. The Company is focused on developing NTF cells from the patient's own bone marrow in order to treat, Parkinson, ALS, and Spinal Cord Injury
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