Biotechnology company BriaCell Therapeutics Corp. (BCTX) announced Tuesday that the independent Data Safety Monitoring Board (DSMB) has completed its third scheduled safety data review of BriaCell's pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer (NCT06072612).
Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. This marks the third consecutive positive recommendation from the DSMB affirming the favorable safety profile observed to date.
BriaCell's pivotal Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration (FDA), reflecting the significant unmet medical need in this patient population.
"The third consecutive DSMB review is a meaningful milestone in our Phase 3 trial, which continues to highlight the excellent safety and tolerability profile of BriaCell's regimen," commented Dr. William V. Williams, BriaCell's President & CEO.
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