BriaCell Therapeutics Corp (C:BCT)
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Last Close 5/17/2016 $0.18
Wednesday May 18 2016 - News Release
Dr. Charles Wiseman reports
BRIACELL APPOINTS CONTRACT RESEARCH ORGANIZATION, CANCER INSIGHT, TO MANAGE ITS UPCOMING PHASE I/IIA CLINICAL TRIALS IN ADVANCED BREAST CANCER
BriaCell Therapeutics Corp. 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 ™}, 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{A ™} 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{A ™}," 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{A ™} 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{A ™} 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{A ™}, 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{A ™} 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 ™}, a companion diagnostic test.
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