BriaCell Provides Clinical Update on its Ongoing Phase I/IIa Clinical Study of BriaVax(TM) in Advanced Breast Cancer
BERKELEY, CA and VANCOUVER, BC --(Marketwired - July 19, 2017) -
BriaCell Therapeutics Corp. ("BriaCell" or the "Company") (TSX VENTURE:
BCT) (OTCQB: BCTXF), an immuno-oncology focused biotechnology company, provided a clinical
update regarding its US-based open-label Phase I/IIa clinical trial evaluating the safety and efficacy of BriaVax™, a genetically
engineered whole-cell vaccine derived from a human breast cancer cell line, to treat advanced breast cancer.
"Our third patient has enrolled in the study, and we continue to see good progress in our clinical program. We continue to
receive a high level of interest from patients with advanced breast cancer for this new treatment option. We remain optimistic
regarding the prospects of this exciting trial, and are pleased that we remain on track to complete the enrollment of the first
10 patients by the end of Sept 2017. Interim data in these patients should be available in 1Q2018. These patients have widely
metastatic breast cancer and have failed prior treatments," stated Dr. Bill Williams, President & CEO of BriaCell.
"We are evaluating the efficacy profile of BriaVax™ in addition to its safety profile. Furthermore, we will be
assessing specimens from these patients using biomarkers to design BriaDx™, a diagnostic test to allow us to select the patients
for which the vaccine will work at its best. We expect this innovative approach to be highly effective for the treatment of
advanced breast cancer patients who have failed previous treatments, and have little to no therapeutic options for this deadly
disease," stated Dr. Williams.
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 an evaluation of the 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.
About BriaCell
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 breast 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. Other forward-looking information in this news release includes
but is not limited to the intended use of proceeds of the Offering and other terms of the Offering, the expected timing of
completion of the Offering, the Company's ability to satisfy the conditions to completion of the Offering and the need for
additional financing.
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.
Attachment Available: http://www.marketwire.com/library/MwGo/2017/7/19/11G142907/BriaCell_19July2017-c825dd43cf7487d5b2ce8139c08ae454.pdf