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|BrainStorm Announces Second U.S. Manufacturing Site for NurOwn® Production|
"We are pleased to announce a second partnership with Dana-Farber for the manufacturing of NurOwn," said
"We are pleased to support this important clinical trial. ALS is a devastating disease with no effective therapies. Our participation will allow more rapid patient accrual and will lead to earlier completion of the study," said
In partnering with Dana-Farber for the manufacturing of NurOwn, BrainStorm has secured an additional facility to enhance production for the ongoing pivotal Phase 3 clinical trial, and to support manufacturing capacity for additional clinical indications.
BrainStorm is also pleased to update that CMC activities at City of Hope and enrollment in all six U.S. clinical sites are proceeding well. The first meeting of the Phase 3 Data and Safety Monitoring Board (DSMB) is expected by the end of
The Phase 3 trial is designed to enroll 200 patients with ALS, and is being conducted at six leading ALS clinical sites in the U.S. The primary outcome measure is the ALSFR-S score responder analysis. For more information, please refer to www.clinicaltrials.gov, using the NCT identifier NCT03280056.