BriaCell Adds Third Clinical Site – Led By Top Physician-Scientist Dr. Lukas – To Expand Phase I/IIa Clinical Trial In Advanced Breast Cancer
Published: Sep 25, 2017
BERKELEY, Calif. and VANCOUVER, British Columbia, Sept. 25, 2017 (GLOBE NEWSWIRE) -- 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.
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:
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