BrainStorm Succeeds on Safety Analysis in Phase 3 ALS Therapy Trial

BrainStormCell Therapeutics Inc., (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerativediseases, 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.

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.

To date, 82 participants have been enrolled in the trial, with 61 currently active. Many of the active participants have received two intrathecal treatments, with some completing all three. The Company anticipates that 110 participants in total will be enrolled in the trial by January 2019. Given the current pace of enrollment, we anticipate completing enrollment by mid 2019, which would then put us in a position to file a Biologics License Application for US FDA approval, once all clinical trial evaluations are completed.

BrainStorm is focused on completing the NurOwn ALS Phase 3 study and to bringing a much needed treatment option to ALS patients, said ChaimLebovits, president and CEO ofBrainStorm, We welcome the DSMBs review which confirms the safety profile of NurOwn following repeat dose intrathecal administration.

Ralph Kern MD, MHSc, Chief Operating Officer and Chief Medical Officer of BrainStorm said, “We are very pleased the DSMB has found no safety concerns that would require modification to the NurOwn ALS Phase 3 protocol. This represents an important clinical advancement for BrainStorm and for NurOwn as a viable cellular therapy approach for ALS patients.

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