Clinical Trials

Phase I/IIa Clinical Study of Bria-IMT™ in Advanced Breast Cancer

BriaCell is currently recruiting patients to evaluate the safety and activity of Bria-IMT™ in an additional Phase I/IIa study in 25-40 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

Roll-Over Combination Therapy Study

FDA has approved the roll-over combination study of Bria-IMT™ 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 SV-BR-1-GM 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 Bria-IMT™ 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

Clinical Development Timeline – Breast Cancer

We conducted two Proof of Concept clinical trials, one using parental SV-BR-1 cells and the other using Bria-IMT™ (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 Proof of Concept Trial:

  • 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 Proof of Concept Trial:

  • Used Bria-IMT™ (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