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BrainStorm Cell Therapeutics Announces Successful Interim Safety Analysis in Phase 3 Trial of NurOwn® Therapy for ALS
Aug. 23, 2018 08:48AM PST
Biotech InvestingBrainStorm Cell Therapeutics (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the independent Data Safety Monitoring Board (DSMB) has completed the pre-specified interim analysis of safety outcomes for the first 31 participants treated with NurOwn in the Phase 3 trial in ALS (NCT03280056). The DSMB indicated there were no significant safety …
BrainStorm Cell Therapeutics (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the independent Data Safety Monitoring Board (DSMB) has completed the pre-specified interim analysis of safety outcomes for the first 31 participants treated with NurOwn in the Phase 3 trial in ALS (NCT03280056). The DSMB indicated there were no significant safety concerns and recommended that the trial continue, as planned.
As quoted in the press release:
“The DSMB appreciates the continued commitment of Brainstorm and the research teams to conducting this trial in such an exemplary manner”, said Carlayne Jackson MD, DSMB Chairperson, “We commend them on their outstanding enrollment and the quality of data collection.”
BrainStorm is conducting a repeat dose US Phase 3 trial of NurOwn® for ALS participants at 6 US sites, supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The study is expected to enroll 200 ALS participants, randomized 1:1 to NurOwn® or placebo, and is evaluating the ALS functional rating scale (ALSFRS-R) as the primary efficacy outcome measure, 28 weeks after the first of three NurOwn® intrathecal treatments.