BrainStorm Cell Therapeutics Inc., a leader in developing innovative autologous cellular therapies for neurodegenerative diseases, announced the enrollment of the first patient in its Phase 2 open-label, multicenter study. This study focuses on the repeated intrathecal administration of autologous MSC-NTF cells in participants with progressive Multiple Sclerosis (MS).
Chaim Lebovits, president and CEO of BrainStorm, highlighted the importance of this milestone during MS Awareness Week, emphasizing the lack of U.S. FDA approved therapies for more than one progressive form of MS. The company's NurOwn® technology platform is being deployed in this new indication, with plans to announce additional clinical trial sites soon.
Ralph Kern, MD MHSc, Chief Operating and Chief Medical Officer of BrainStorm, stated that the enrollment of the first participant marks a significant milestone in their commitment to addressing the unmet medical need in progressive MS. The company aims to quickly initiate enrollment across all study sites, with top-line data expected by the middle of 2020.
Multiple Sclerosis is a chronic neuroinflammatory and neurodegenerative disorder affecting the brain and spinal cord, impacting approximately 1 million individuals in the U.S. and 2.5 million worldwide. About half of those affected will develop a progressive form of the disease, leading to increased levels of motor, visual, and cognitive functional impairment and disability.
The NurOwn® technology platform represents a promising investigational therapeutic approach, with autologous MSC-NTF cells produced from bone marrow-derived mesenchymal stem cells. These cells are designed to secrete high levels of neurotrophic factors, offering potential for immunomodulation, remyelination, and neuroprotection in progressive MS.
BrainStorm is also conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS) and has received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS, with enrollment beginning in March 2019.
For more information on the clinical trial, visit www.clinicaltrials.gov using the NCT identifier (NCT03799718).
