BrainStorm Cell Therapeutics Inc., a clinical-stage biotechnological company developing noncontroversial, adult stem cell therapeutic products, derived from autologous (self) bone marrow cells, for the treatment of chronic, life-threatening neurodegenerative disorders, has announced that it has signed a Memorandum of Understanding with Massachusetts General Hospital and the University of Massachusetts Medical School in anticipation to apply for FDA approval to commence ALS human clinical trials in the U.S.

The parties have agreed to take on initial preparatory steps for the partnership, which includes developing a protocol for the ALS human clinical trials and the selection of the appropriate facilities for production in the U.S. prior to entering into the more definitive agreements for this collaboration.

BrainStorm was also granted the FDA Orphan Drug Designation for its NurOwn(TM) treatment for ALS. This partnership is the next step for the inclusion of additional patients who suffer from ALS in clinical trials through the extension of BrainStorm’s clinical trials to medical centers in the U.S. all according to FDA regulations.

Professor Robert Brown, D. Phil., MD, Chair of the Neurological Department at the University of Massachusetts Medical School, will lead the team at the University of Massachusetts Medical School. Professor Brown is an expert in the area of neuromuscular genetics and is known around the world for his expertise in ALS. Investigators at the University of Massachusetts Medical School have discovered numerous fundamental processes for the control of gene expression and are pursuing the application of these discoveries to treat diseases such as ALS.

Massachusetts General Hospital is a medical facility recognized around the world and has a vast medical expertise in the study and treatment of patients suffering from neurodegenerative diseases, which includes ALS. Professor Merit Cudkowicz, an expert in therapy development and clinical trial design for neurodegenerative disorders, will be leading the team. She co-chairs the Northeast ALS Consortium and is the director of the Massachusetts General Hospital Neurology Clinical Trial Unit. She has led numerous clinical trials developing new treatments for those who suffer from ALS.

Professor Robert Brown said, “Professor Cudkowicz and I are delighted to join forces with BrainStorm to prepare for BrainStorm’s first human clinical trials in the United States. We are hopeful that together we may achieve a breakthrough for the treatment of people suffering from ALS. This trial will be conducted after receiving all necessary FDA approvals and in parallel with the human clinical trials that are being conducted by BrainStorm in Israel in collaboration with the Hadassah Medical Center.”

“We are extremely pleased to enter into collaboration with Massachusetts General Hospital and the University of Massachusetts,” stated Chaim Lebovits, President of BrainStorm. “Both are world renowned medical organizations with proficiency in ALS treatment and have been providing ALS treatments to patients for quite some time. We are extremely delighted to be particularly working together with Professors Brown and Cudkowicz, both of whom are world-wide leaders in the field of ALS. This collaboration provides BrainStorm with the medical expertise and support needed to prepare for its first ALS human clinical trials in the United States, in parallel to BrainStorm’s human clinical trials that are underway at the Hadassah Medical Center in Israel.”

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