BERKELEY, CA and VANCOUVER, BC–(Marketwired – May 18, 2016) – BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX VENTURE: BCT) (OTCQB: BCTXF) is pleased to announce that it has signed a definitive agreement with Cancer Insight, LLC, a cancer-vaccine focused clinical research organization (CRO), to initiate Phase I/IIa clinical studies and regulatory filings for BriaVax™, its lead vaccine candidate for the treatment of advanced breast cancer. According to the agreement, BriaCell will sponsor the clinical trial which will evaluate the safety and efficacy of BriaVax™, a novel vaccine, for the treatment of advanced breast cancer, and Cancer Insight will provide clinical and regulatory affairs management services for the entire trial.
With over a decade of scientific and clinical expertise in cancer immunotherapy, Cancer Insight is a leading clinical research organization that specializes in the discovery, development, and testing of novel cancer vaccines. The team at Cancer Insight is led by Dr. George Peoples, a trained surgical oncologist, and a leading expert in breast cancer vaccines and immunotherapy, currently overseeing clinical trials at over 32 clinics.
“Appointing Cancer Insight to support us in further clinical advancement of BriaVax™ is a major milestone for BriaCell,” states Dr. Charles Wiseman, Founder and Director of BriaCell. “Cancer Insight’s solid track record of successfully conducting clinical trials for breast cancer vaccines and immunotherapies, its expertise in regulatory affairs, and its strong ties with leading academic and research institutions including MD Anderson Center would make it an ideal choice of a CRO for further clinical development of BriaVax™,” Dr. Wiseman added. “We have been carefully selecting our partners to be those with extensive experience in manufacturing, regulatory, and clinical development aspects of our cancer vaccine.”
“Cancer Insight is extremely pleased that BriaCell has chosen us as a partner to manage this innovative Phase I/IIa program for BriaVax™ in advanced breast cancer. Our company is highly experienced in the breast cancer vaccine space, and is a leader in conducting biomarker and imaging analysis studies for the clinical advancement of cancer vaccine candidates. Using our unique platform, BriaVax™ will be tested for its anti-tumor effects at multiple sites, in addition to breast tumors — its primary focus — as authorized by the FDA in the Phase I/IIa program,” Cancer Insight’s Founder, Dr. George Peoples stated. “We will use a strict audit program to review the data and reports from the previous clinical studies as well as those from the upcoming Phase I/IIa clinical trials for future FDA discussions,” Dr. Peoples concluded.
The vaccine, BriaVax™, is a whole-cell breast cancer vaccine genetically engineered to release GM-CSF, a natural substance the body amplifies to activate 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 new Phase I/IIa study will evaluate BriaVax™ in up to 24 advanced breast cancer patients. The dosing of patients is scheduled to begin this summer which will be followed by co-development of BriaDx™, a companion diagnostic test.
BriaCell is an immuno-oncology biotechnology company developing a more targeted, less toxic approach to cancer management. BriaCell’s mission is to serve late-stage cancer patients with limited 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, is a genetically engineered whole-cell vaccine derived from a human breast tumor cell line. This targeted vaccine is believed to generate strong antibody and T-cell responses, which in turn may boost the immune system to recognize and eliminate cancerous cells. 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 FDA Phase I clinical trials have been encouraging in terms of both safety and efficacy in patients with advanced solid tumors (17 breast cancer, 1 ovarian cancer).
In some cases, the lifespan of the patient was extended by three to five fold of that of the comparable trials. For more information, please visit www.briacell.com.
About Cancer Insight, LLC.
With over a decade of scientific and clinical expertise in cancer immunotherapy, Cancer Insight is a leading Clinical Research Organization focused on discovering, developing and testing emerging cancer immunotherapies with the aim of preventing cancer using vaccination to ultimately eradicate the disease. The company offers an innovative, state-of-the-art approach to product development to accelerate approval timelines and maximize the value of immunotherapy biologics through Phase I-IV studies. The company provides a full range of services including clinical study design, management, regulatory affairs, and quality assurance among other pre- and post-marketing services.
For more information on Cancer Insight, LLC, please visit http://www.cancerinsight.com.
For further information contact:
Ms. Farrah Dean
Manager, Corporate Development
BriaCell Therapeutics Corp.
820 Heinz Avenue
Berkeley, CA 94710
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