BriaCell Therapeutics Corp.
("BriaCell" or the
"Company") (TSX-V:BCT) (OTCQB:BCTXF), an
immuno-oncology focused biotechnology company with a proprietary
vaccine technology, is pleased to announce the opening of a third
clinical site. Jason Lukas, MD, PhD, a Board-Certified
Oncologist – experienced with breast cancer vaccines – at the
Everett Clinic and Providence Regional Medical Center, WA, will
lead the clinical study as principal investigator for this
site. Dr. Lukas will work closely with Cancer Insight, LLC,
BriaCell’s contract research organization, to manage the clinical
and regulatory aspects of the clinical trial on behalf of BriaCell.
The site, the Providence Regional Medical Center
Everett (Everett, WA), is known for providing high quality health
care services to all patients including the ones most in need.
“Dr. Lukas’ enthusiasm, knowledge, and
experience of leading the breast cancer vaccine clinical trials
will be of great value to us, and we are grateful to have him as a
principal investigator for the Phase I/IIa clinical trials of
BriaVax™,” stated Dr. Williams, BriaCell’s President & CEO. “We
look forward to expanding our clinical trial and immunotherapy
partnerships with leading hospitals in diverse geographical
regions, and we are pleased to have Providence Regional Medical
Center Everett, which is committed to high quality patient care, as
one of our sites for the clinical trial of BriaVax™. We expect the
addition of the third site to further facilitate the patient
enrollment in our ongoing clinical trial with BriaVax™,” Dr.
Williams added.
“Cancer is a devastating and life changing
event that drives people into a therapeutic and psychological
maze. Enhancing the immune system is fast becoming a leading means
to holistically help the patients through the labyrinth. We
are delighted to provide these advanced breast cancer patients with
a potentially safe and effective treatment option,” stated Dr.
Lukas. “Based on the impressive safety and efficacy data of
BriaVax™ in advanced breast cancer patients in a preliminary
clinical trial, we are excited to work with the BriaCell team to
advance the clinical development of BriaVax™.”
Dr. Jason Lukas, MD, PhD, is a research
scientist and Board-Certified oncologist with a great deal of
knowledge and focus in breast cancer vaccines and "targeted
therapy". While on active duty with the US Navy, Dr. Lukas worked
to enhance healthcare and to develop the healthcare infrastructure
in Afghanistan, and now, as a Navy Reservist, oversees trials of
the NeuVax breast cancer vaccine at Everett. He obtained his
medical degree at Drexel School of Medicine (previously Hahnemann)
in 2002, and his doctorate degree at University of Southern
California in 1998 with an outstanding graduate student award. Dr.
Lukas completed his Residency in Internal Medicine, at University
of Washington, and his Fellowship in Hematology/Oncology at
University of California, San Francisco.
Providence Health & Services, which includes
the Providence Regional Medical Center Everett, is the largest
health care provider in Washington State, with its network
including hospitals, clinics, senior care centers and home health
services. As a mission-based, not-for-profit health care provider,
Providence Health & Services provides compassionate care to all
patients including those in need.
BriaVax™ is a whole-cell breast cancer vaccine
genetically engineered to release granulocyte macrophage
colony-stimulating factor (GM-CSF), a substance that activates the
immune system. Previously, a small Phase I study documented very
prompt and near complete regression of metastatic breast cancer
deposits in the breast, lung, soft tissue, and even the brain. The
ongoing open-label Phase I/IIa study will evaluate BriaVax™ in up
to 40 advanced breast cancer patients. This trial is listed in
ClinicalTrials.gov as NCT03066947. The trial is being
conducted along with the co-development of BriaDx™, our companion
diagnostic test. The interim data for the first 10 patients is
expected by the first quarter of 2018.
About BriaCell
BriaCell is an immuno-oncology focused
biotechnology company developing a targeted and safe approach to
the management of cancer. 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 whole-cell breast cancer vaccine genetically engineered to
release granulocyte macrophage colony-stimulating factor (GM-CSF),
a substance that activates the immune system by allowing the body
to recognize and eliminate cancerous cells by inducing
tumor-directed T cell and potentially antibody responses.
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 cancer. Most notably, one patient
with metastatic breast cancer responded to BriaVax™ with
substantial reduction in tumor burden including lung and brain
metastases. The company is currently conducting a Phase I/IIa
clinical trial for BriaVax™ in patients with advanced breast cancer
whose disease has progressed following at least one prior treatment
course. This trial is listed in ClinicalTrials.gov as
NCT03066947. The trial is being conducted along with the
co-development of BriaDx™, our companion diagnostic test. The
interim data for the first 10 patients is expected by the first
quarter of 2018.
For additional information on BriaCell, please
visit our website: http://briacell.com
About the Phase I/IIa Clinical
Trial
In a previous Phase I setting, a patient with
metastatic breast cancer responded to BriaVax™ with objective
reduction in tumor burden. To expand on this finding, after
updating the clinical protocol of the original investigational new
drug (IND) application, an open-label Phase I/IIa clinical trial
enrolling up to 40 late stage breast cancer patients with recurrent
and/or metastatic disease has been launched. 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 Phase I/IIa
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
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.
Contact Information
For further information, please contact:
BriaCell Therapeutics
Corp.:Farrah DeanManager, Corporate DevelopmentEmail:
farrah@BriaCell.com Phone: 1-888-485-6340
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