BrainStorm Announces NurOwn® Expanded Access Program :
BrainStorm Announces NurOwn® Expanded Access Program
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NEW YORK, Dec. 14, 2020 /PRNewswire/ BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today the initiation of a NurOwn® (MSC-NTF cells) Expanded Access Program (EAP) for patients with amyotrophic lateral sclerosis (ALS) who completed the Company s recently concluded pivotal Phase 3 clinical trial and meet specific eligibility requirements.
The protocol for the EAP was developed in partnership with the United States Food and Drug Administration (FDA) to provide access to NurOwn for Phase 3 clinical trial participants who meet specific eligibility criteria. Initially, patients less severely affected by ALS, as measured by the Revised ALS Functional Rating Scale (ALSFRS-R), will be the first to receive treatment. This approach is informed by recently announced topline data from the Company s Phase 3 clinical trial. According to the
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