Berkeley, CA and Vancouver, BC – May 8, 2017 – BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV: BCT) (OTCQB: BCTXF), an immuno-oncology focused biotechnology company, today announced dosing of the first patient in BriaCell’s Phase I/IIa clinical trial evaluating the Company’s lead product candidate, BriaVaxTM, a genetically engineered whole-cell vaccine derived from a human breast tumor cell line, in patients with advanced breast cancer.
“We are delighted to announce formal commencement of the Phase I/IIa trial of BriaVax™, a significant milestone for our promising platform technology and program,” commented Dr. Bill Williams, President & CEO of BriaCell. “We expect this study to confirm the robust safety profile of BriaVax™ previously observed in two preliminary Phase I trials in advanced breast cancer patients, as well as preliminary efficacy signals.”
“The initiation of this clinical trial brings us one step closer to provide a promising safe alternative to existing treatment options,” stated Dr. Charles Wiseman, BriaCell’s scientific founder. “We look forward to providing a targeted immunotherapy that has the capability to expand into additional solid tumors, which can also be combined with other treatment agents.”
“We are co-developing a diagnostic, BriaDx™, in parallel with the Phase I/IIa study, which we believe will ultimately assist in identifying the patients most likely to benefit from treatment with BriaVax™,” stated Dr. Markus Lacher, Head of Research and Development at BriaCell. “I am very optimistic that this clinical study — together with our already obtained excellent preliminary data — will provide us with the results necessary to complete the first version of BriaDx™ and prepare it for validation in future clinical trials, potentially opening a path for accelerated clinical development of BriaVax™.”
About the Phase I/IIa Clinical Trial Protocol
The Phase I/IIa clinical trial is an open-label study enrolling up to 24 late-stage breast cancer patients with recurrent and/or metastatic disease. Patients will be administered BriaVax™ every two weeks for the first month of treatment, then monthly up to one year.
The primary objective of the clinical trial is to evaluate the safety of BriaVax™ in study subjects, and the principal secondary objective is evaluation of tumor size reduction. Tumor response will be monitored every three months during the study. The trial will also evaluate progression-free survival (PFS) and overall survival (OS).
For additional details regarding the clinical trial, please visit: https://www.clinicaltrials.gov/ct2/show/NCT03066947.
BriaCell is an immuno-oncology focused biotechnology company developing a more targeted, less toxic approach to cancer management. BriaCell’s mission is to serve late-stage cancer patients with no available treatment options.
Immunotherapy has come to the forefront of the fight against cancer, harnessing the body’s own immune system in recognizing and selectively destroying the cancer cells while sparing normal ones. Immunotherapy, in addition to generally being more targeted and less toxic than commonly used types of chemotherapy, is also thought to be a strong type of approach aimed at preventing cancer recurrence.
BriaVax™, the Company’s lead product candidate, is a genetically engineered whole-cell vaccine derived from a human breast tumor cell line. It is believed to activate the immune system to recognize and eliminate cancerous cells by inducing tumor-directed T cell and potentially antibody responses. The Company has already demonstrated encouraging clinical results, and is intent on building upon these results to further advance BriaVax™ through additional FDA-approved clinical trials in order to help cancer patients with limited therapeutic options. The results of two previous Phase I clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with BriaVax™) have been encouraging in patients with advanced solid tumors. Most notably, one patient with metastatic breast cancer responded to BriaVax™ with substantial reduction in tumor burden including lung and brain metastases.
For additional information on BriaCell, please visit our website: http://briacell.com/
Cautionary Note Regarding Forward-Looking Information
Except for the statements of historical fact, this news release contains “forward-looking information” within the meaning of the applicable Canadian securities legislation which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. These risks are more fully described in the Company’s public filings available at www.sedar.com.
Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For further information, please contact:
BriaCell Therapeutics Corp.:
Manager, Corporate Development
Burns McClellan, Inc.:
Bill Slattery, Jr.
Manager, Investor Relations