U.S. Phase 2 Study to Begin in First Quarter of 2019
NEW YORK, Dec. 17, 2018 — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases, today announced that 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.