Core Insights - BriaCell Therapeutics Corp. has received a positive recommendation from the external Data Safety Monitoring Board (DSMB) to continue its pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer without modifications [1][6] - The study is currently under Fast Track Designation with the FDA, indicating its potential significance in addressing an urgent medical need [1][6] Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [3] - The company emphasizes the importance of its research in improving survival and quality of life outcomes for patients with metastatic breast cancer [2] Clinical Study Details - The pivotal Phase 3 study is designed to evaluate the safety and efficacy of Bria-IMT in combination with CPI for patients with metastatic breast cancer [1][6] - The DSMB's second safety data review found no safety concerns, allowing for the continuation of patient enrollment in the clinical trial [2][6]
Second Data Safety Monitoring Board Issues Positive Recommendation to Continue BriaCell's Phase 3 Study in Metastatic Breast Cancer