BriaCell Doses Second Patient in Phase I/IIa Clinical Study of BriaVax™
in Advanced Breast Cancer
June 1, 2017
Berkeley, CA and Vancouver, BC – June 1, 2017 – BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV: BCT) (OTCQB: BCTXF), an immuno-oncology focused biotechnology company announced today it has enrolled the second patient in a USA-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 tumor cell line, to treat advanced breast cancer.
“We are very pleased with the execution of the highly experienced clinical team who has enrolled so far two patients in the study. Both patients have widely metastatic breast cancer and have failed prior treatments,” stated Dr. Bill Williams, President & CEO of BriaCell. “These patients are in desperate need of new treatment options, and we are very pleased that the clinical site at Saint Joseph’s Medical Center in Santa Rosa reports a high level of interest in this study among their patients.”
“In addition to measuring the safety profile of BriaVax™, we are evaluating BriaVax™ as a potential therapeutic to reverse the advanced breast cancer’s tumor progression. This would represent a significant breakthrough for the treatment of advanced breast cancer patients who have failed previous treatments, and have little to no therapeutic options for this deadly disease. We are encouraged that both patients continue on BriaVax™,” stated Dr. Williams.
“BriaVax™ is a novel targeted cancer immunotherapeutic which we hypothesize activates specific components of the immune system to recognize and kill tumor cells. We are currently studying the biological markers that we believe are key to this activity and working on the development of BriaDxTM to predict which patients with advanced breast cancer are most likely to respond to BriaVax™”, stated Dr. Markus Lacher, BriaCell’s head of R&D. “The enrollment of our second patient is an encouraging sign that we are on-track in our development program for both BriaVax™ and the first version of BriaDx™.”
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.
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. 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.
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For further information, please contact:
BriaCell Therapeutics Corp.:
Manager, Corporate Development