Berkeley, CA and Vancouver, BC – July 31, 2017 – BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV: BCT) (OTCQB: BCTXF), an immuno-oncology focused biotechnology company with a proprietary vaccine technology, is pleased to announce the opening of a new clinical site, Florida Cancer Care in Plantation, FL and the appointment of Dr. Elizabeth Tan-Chiu, a board certified breast medical oncologist and Founder and Research Director of Florida Cancer Care in Plantation, FL, as the clinical site’s principal investigator. Dr. Tan-Chiu 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.
Dr. Elizabeth Tan-Chiu is a highly respected research scientist and oncologist with experience in all medical aspects of breast and ovarian cancer treatment including anti-hormonal therapy, chemotherapy and “targeted therapy”. Through her work with the National Surgical Adjuvant Breast and Bowel Project (NSABP), Dr. Tan-Chiu excelled her research ambitions under the mentorship of Dr. Bernard Fisher, a pioneer in the biology and treatment of breast cancer. She has authored and co-authored numerous publications, and participated in clinical trials of virtually every aspect of breast cancer treatment including pioneering work in the use of Trastuzumab (Herceptin), Bevacizimab (Avastin) and Lapatanib (Tykerb) therapies.
“We are impressed with Dr. Tan-Chiu’s credentials and her profound knowledge and experiences in the management of breast cancer clinical trials, and we are grateful to have her as a principal investigator for the Phase I/IIa clinical trial of BriaVax™, our lead vaccine candidate for management of advanced breast cancer,” stated Dr. William Williams, President & CEO of BriaCell. “We are committed to excellence in patient care, and we are delighted to have Florida Cancer Care, which is known for outstanding cancer care, as our second site for the clinical trials of BriaVax™. We expect that the addition of Florida Cancer Care will provide availability to the vaccine for patients in the eastern regions of the US and speed up the process of patient enrollment in our ongoing clinical trial with BriaVax™.”
“We are excited to join the team to evaluate the safety and activity of BriaVax™ in patients with advanced breast cancer with the goal of making treatments available to patients with few treatment options,” commented Dr. Tan-Chiu. “We are very impressed with preliminary safety and efficacy data of BriaVax™ in advanced breast cancer patients, and look forward to working with the BriaCell team to advance the clinical development of its lead drug candidate.”
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 24 advanced breast cancer patients. This trial is listed in ClinTrials.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 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 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.
For additional information on BriaCell, please visit our website: http://briacell.com
About the Phase I/IIa Clinical Trial
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:
About Florida Cancer Care
Based in Broward and Palm Beach, Florida Cancer Care (FCRI) provides both domestic and international patients with the most innovative cancer care with the highest level of service. The physicians, dedicated to excellence, have been recipients of numerous honors and awards with a longstanding track record to provide the best quality service – consistently throughout the years – to their patients.
FCRI is deeply committed to finding new and improved ways to prevent, diagnose and treat cancer. It offers FDA approved clinical research trials to provide the patients alternatives other than generic therapies usually offered by other general oncologists. The patients and physicians are encouraged to help conquer cancer by joining FCRI network and play an integral part in the development of new and better therapies.
For additional information on Florida Cancer Care, please visit: http://www.floridacancercare.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 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.
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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BriaCell Therapeutics Corp.:
Manager, Corporate Development