BriaCell Provides Clinical Update on its Ongoing Phase I/IIa Clinical Study of BriaVaxTM in Advanced Breast Cancer
- Category: Vaccines
- Published on Thursday, 20 July 2017 09:12
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BERKELEY, CA, USA and Vancouver, Canada I July 19, 2017 I BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV: 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.
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/