BriaCell (BCTX) Therapeutics reports that the independent Data Safety Monitoring Board, iDSMB, has completed its third scheduled safety data review of BriaCell’s pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor in metastatic breast cancer. Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly as per the study protocol, and this marks the third consecutive positive recommendation from the DSMB affirming the favorable safety profile observed to date. Bria Cell’s pivotal Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration, reflecting the significant unmet medical need in this patient population.
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