FDA OKs Further Brainstorm NurOwn® Dosing Under Expanded Access Program

 BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced plans for a dosing extension of NurOwn® for participants who completed the Expanded Access Protocol (EAP). The U.S. Food and Drug Administration (FDA) recommended that BrainStorm submit an EAP protocol amendment to provide additional dosing for these participants. Under the original EAP protocol, participants who had completed the Phase 3 NurOwn trial and who met specific eligibility criteria had the opportunity to receive 3 doses of NurOwn. Under the amended EAP protocol, these eligible participants will receive up to 3 additional doses. Data collected from the original EAP treatments informed the decision to move forward with additional doses for participants who completed it.

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