Trial Underway!
BriaCell Phase 1/2a Trial Underway
On March 15, 2017, BriaCell Therapeutics Corp. (TSXV: BCT) (BCTXF) announced that the U.S. FDA had granted
clearance to initiate the Phase 1/2a clinical trial of BriaVax™ in patients with advanced breast cancer. This is an
important step for the company and represents many years of hard work by management to get BriaVax back into the
clinic, including finalizing the necessary CMC work around a new manufacturing process for the whole-cell vaccine.
I'm expecting the first patients to be dosed shortly. The principal investigator is Dr. Jarrod P. Holmes at St. Joseph
Heritage Healthcare in Santa Rosa, California. Dr. Holmes is a Board Certified Oncologist and a leading expert in cancer
vaccines. Cancer Insight, LLC, led by Dr. George Peoples, a surgical oncologist and leading expert in cancer vaccines, is
managing the clinical study. Biologics Consulting is handling regulatory affairs.
The Phase 1/2a Program
The Phase 1/2a trial (NCT03066947) is expected to enroll up to 24 late-stage cancer patients with recurrent and/or
metastatic breast cancer who have failed at least one line of prior therapy (ECOG 0-2). The single-arm, open-label study
is designed to determine the optimal dosing regimen and safety profile of the targeted immunotherapy. The primary
endpoint is the incidence of treatment-emergent adverse events following multiple injections of BriaVax. The current
protocol calls for inoculation of the vaccine at baseline and then every 2 weeks for one month (3 treatments), then
monthly for up to one year.
Standard tumor assessments will be performed at baseline and then every 3 months. Important secondary outcome
measures include overall survival (OS), objective response rate (ORR), progression free survival (PFS), and durability of
tumor response. Other measures including patient quality of life, performance status, weight, and pain will also be
measured. After at least 9 subjects have been treated safely, the dose of BriaVax may be escalated or decreased in
subsequent patients based on the emerging data.
