FDA Accepts BrainStorm’s NurOwn IND Application for Progressive Multiple Sclerosis

BrainStorm Cell Therapeutics announced the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application to initiate a Phase 2 clinical trial of NurOwn for the treatment of progressive multiple sclerosis (MS).

There are currently no FDA approved autologous cellular therapies addressing MS or other neurological diseases. While treatment options for patients with MS exist, there remains a significant unmet need in progressive MS. There is currently no FDA approved therapy that addresses more than one progressive form of MS.

"This is an extremely exciting moment as we expand BrainStorm’s pipeline by introducing a new indication for NurOwn® in neurodegenerative disease," said Chaim Lebovits, president and CEO of BrainStorm. "Through this trial, we are advancing a novel treatment modality into clinical-stage testing for progressive MS in early 2019."

MS affects approximately one million individuals in the U.S. and 2.5 million individuals worldwide. Approximately half of affected individuals will eventually develop progressive disease, which may lead to increasing levels of motor, visual, and cognitive functional impairment and disability.

"We are excited about the launch of early testing of this cell-based approach to treating progressive MS, for which there are few treatment options," said Bruce Bebo, Ph.D., Executive Vice President of Research at the National MS Society. "We look forward to better understanding the potential benefits and safety of this and other cell-based therapies for MS."

"We are excited to participate in this Phase 2 clinical trial and hope that this innovative cell therapy approach leads to a new treatment option for patients with progressive MS," said Dr. Fred Lublin, Director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai Medical Center and Saunders Family Professor of Neurology at Mount Sinai School of Medicine in New York. "We are particularly pleased to see a scientifically rigorous approach to advance the science of stem cell therapeutics."

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