BrainStorm Cell Therapeutics (NASDAQ: BCLI) 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® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) for ALS. Brainstorm has fully enrolled the phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. In December 2018, Brainstorm received U.S. FDA clearance to initiate a phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in progressive multiple sclerosis (NCT03799718) and has been enrolling clinical trial participants since March 2019. For more information, visit the company’s website at https://brainstorm-cell.com/
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