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 is currently recruiting patients to 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.

For the details of the trial, please visit For the details of the trial, please visit https://www.clinicaltrials.gov/ct2/show/NCT03066947.

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

Breast Cancer Opportunity

BriaCell is currently recruiting patients for its Phase I/IIa clinical study – designed to test the safety and efficacy of BriaVax™ in metastatic breast cancer patients who have failed at least one course of treatment.

For the details of the trial, please visit For the details of the trial, please visit https://www.clinicaltrials.gov/ct2/show/NCT03066947

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.

Roll-Over Combination Therapy Study

FDA has approved the roll-over combination study of BriaVax™ with pembrolizumab (Keytruda; manufactured by Merck & Co., Inc.) or ipilimumab (Yervoy; manufactured by Bristol-Myers Squibb Company) for patients previously treated with BriaVax™ from the ongoing Phase I/IIa Clinical Trial in Advanced Breast Cancer. The study is available for patents on the BiaVax™ Phase I/IIa study who develop progressive disease. These patients will be eligible to roll-over into combination therapy with Keytruda or Yervoy, depending on the type of breast cancer they have.

More information on the roll-over combination study of BriaVax™ with either ipilimumab or pembrolizumab will be available on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03328026)

KEYTRUDA® (pembrolizumab)

Manufactured by Merck & Co., Inc., KEYTRUDA® (pembrolizumab) is a prescription medicine that may treat certain cancers by working with the immune system. It has been approved for the treatment of a number of cancer indications excluding breast cancer.

For more information on pembrolizumab, please see:
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf

About YERVOY® (ipilimumab)

Manufactured by Bristol-Myers Squibb Company, YERVOY® (ipilimumab) is a prescription medicine used in adults and children 12 years and older to treat melanoma (a kind of skin cancer) that has spread (metastatic) or cannot be removed by surgery (unresectable). It is a monoclonal antibody that works to activate the immune system and enabling them to recognize and destroy cancer cells.

For more informations on Ipilimumab, please see:
https://packageinserts.bms.com/pi/pi_yervoy.pdf