Clinical Trials

We conducted two Phase I clinical trials, one using parental SV-BR-1 cells and the other using BriaVax™ (i.e., genetically engineered SV-BR-1 cells – producing GM-CSF), in metastatic (i.e., Stage IV) breast cancer patients who had failed prior treatments. The patients were treated according to the following schedule, and the results are summarized below.

 

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First Phase I:

  • Used unmodified cell line  (parental SV-BR-1 cells) + GM-CSF + cyclophosphamide
  • N = 14 late stage, treatment-refractory breast cancer patients
  • No significant adverse treatment-associated events, well tolerated
  • Median Overall Survival = 12.1 months
For further details, please see:

adobe-PDF-iconBriaCell   Dr. Charles Wiseman Article Phase I Trial-14 Patients

Second Phase I:

  • Used BriaVax™ (genetically engineered SV-BR-1 cells – producing GM-CSF) + cyclophosphamide + interferon-α
  • N = 4 late stage, treatment-refractory (3 breast cancer, and 1 ovarian cancer) patients
  • No significant adverse treatment-associated events, well tolerated
  • Median Overall Survival = 35 months
  • One robust responder with >90% regression during treatment, subsequent relapse (upon halting treatment) responded to re-treatment

A case report was published. For details, please see
adobe-PDF-iconBriaCell   Article Clinical Regression

Based on the impressive results of the studies, BriaCell plans to further evaluate the safety and activity of BriaVax™ in an additional Phase I/IIa study in 24 metastatic breast cancer patients who failed at least one prior treatment.

BriaCell recently received the permission from the FDA for further testing of BriaVax™ in advanced breast cancer patients.

Breast Cancer Opportunity

BriaCell is planning to test the safety and efficacy of BriaVax™ in 24 metastatic breast cancer patients who have failed at least one course of treatment.

Opportunity For Other Cancer Indications

The FDA approved protocol for Phase I/II clinical studies in patients with metastatic breast cancer has the provision to allow the testing of the vaccine in patients with other cancers.

If you would like more information regarding the clinical trials or if you are a clinician interested in becoming a principal investigator, please contact us at info@briacell.com.