BrainStorm Cell Therapeutics Announces Submission of IND
BrainStorm Cell Therapeutics Inc. recently announced that it has submitted an Investigational New Drug (IND) application with the US FDA to initiate a Phase 2 study of NurOwn in patients with progressive multiple sclerosis (MS).
“This important step toward the development of NurOwn in progressive MS confirms our commitment to bring to the market innovative cellular therapies for neurodegenerative disease,” said Chaim Lebovits, President and CEO of BrainStorm. “This builds upon the important progress made in advancing NurOwn in the ongoing pivotal study in ALS.”
“We plan to quickly initiate the Phase 2 clinical study of NurOwn in progressive MS to address the significant unmet need for MS patients,” said Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer of BrainStorm. “We believe the demonstrated safety and efficacy experience of NurOwn in our ALS clinical program and the development of neurotrophic factors and other efficacy biomarkers will allow us to confidently expand our cellular therapy pipeline.”
MS affects approximately 1 million individuals in the US and 2.3 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.
BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The company holds the rights to clinical development and commercialization of the NurOwn technology platform through an exclusive, worldwide licensing agreement. NurOwn has received Fast Track designation from the US FDA in ALS and orphan status by the US FDA and the European Medicines Agency (EMA). BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of NurOwn at six sites in the US, supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for US FDA approval of NurOwn in ALS. For more information, visit www.brainstorm-cell.com.
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