BrainStorm Cell Therapeutics Inc (BCLI)

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BrainStorm launches NurOwn Expanded Access Program

Dec. 14, 2020 8:46 AM ETBrainstorm Cell Therapeutics Inc. (BCLI)By: Mamta Mayani, SA News Editor

BrainStorm Cell Therapeutics (NASDAQ:BCLI) has initiated a NurOwn (MSC-NTF cells) Expanded Access Program (EAP) for patients with amyotrophic lateral sclerosis (ALS) who completed the Company's recently concluded Phase 3 trial.
The protocol for the EAP was developed in partnership with the FDA to provide access to NurOwn for Phase 3 clinical trial participants who meet specific eligibility criteria.
Initially, patients less severely affected by ALS will be the first to receive treatment.
The six clinical centers of excellence participating in the Phase 3 NurOwn trial will each have the opportunity to treat ALS patients who completed the trial.
The Dana Farber Cancer Institute will initially manufacture the investigational therapy, assisted by BrainStorm personnel who will be on-site.
NurOwn cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders.