BriaCell Announces First Patient Dosed in Phase I/IIa Clinical Study of BriaVax(TM) in Advanced Breast Cancer
BERKELEY, CA and VANCOUVER, BC --(Marketwired - May 08, 2017) - BriaCell
Therapeutics Corp. ("BriaCell" or the "Company") (TSX VENTURE:
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, BriaVax™, 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.
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 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.
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