BriaCell Therapeutics Corp. Announces Addition of Key Clinical Site to Pivotal Phase 3 Clinical Study in Metastatic Breast Cancer

Strategic Insights -

BriaCell Therapeutics Corp., a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, has announced the addition of Mayo Clinic to its ongoing pivotal Phase 3 clinical study in metastatic breast cancer. The study, which is evaluating BriaCell's lead clinical candidate, Bria-IMT(TM), plus immune checkpoint inhibitor (CPI) versus physician's choice, now has 69 active clinical sites across 15 states. The pivotal Phase 3 clinical study is evaluating the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician's choice as the primary endpoint. Interim data will be analyzed once 144 patient events (deaths) occur.

Key Takeaways:

  • BriaCell Therapeutics Corp. has added Mayo Clinic as a key clinical site to its ongoing pivotal Phase 3 clinical study in metastatic breast cancer.
  • The study now has 69 active clinical sites across 15 states, including Mayo Clinic, DHR Health Oncology Institute, Hematology Oncology Associates of Fredericksburg, and other prominent cancer centers.
  • The pivotal Phase 3 clinical study is evaluating BriaCell's lead clinical candidate, Bria-IMT(TM), plus immune checkpoint inhibitor (CPI) versus physician's choice in advanced metastatic breast cancer (Bria-ABC).
  • The study has received FDA Fast Track designation for the Bria-IMT combination regimen.
  • Dr. Giuseppe Del Priore, BriaCell's Chief Medical Officer, stated, "We are very excited to be working with renowned clinical experts at a leading cancer center like Mayo Clinic, who also participated in BriaCell's Phase 2 study."
  • The interim data analysis will be based on 144 patient events (deaths) occurring, comparing overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician's choice.

Statistics:

  • 69 active clinical sites across 15 states.
  • The study will evaluate overall survival (OS) in patients treated with Bria-IMT combination regimen versus those treated with physician's choice.
  • 144 patient events (deaths) are required for interim data analysis.

Sources:

  • GlobeNewswire.
  • ClinicalTrials.gov (NCT identifiers not provided).
  • BriaCell Therapeutics Corp. (www.briacell.com).
  • SEDAR+ (www.sedarplus.ca).
  • EDGAR (edgar.finance.gov).