October 8, 2015
Positive Release Testing Data From First Lot of Vaccine Submitted to FDA; Contract Negotiations Underway With Initial Clinical Site.
BriaCell Therapeutics Corp (OTCQB: BCTXF) (TSX VENTURE: BCT) (“BriaCell”, the “Company”, or “BCT”) is pleased to announce that the Company has successfully advanced to the final stages of preparation for the upcoming Phase I/IIa study of BriaVax™.
BriaCell has submitted to the US Food and Drug Administration (FDA) final positive results its first lot of BriaVax™ which is to be used in BriaCell’s upcoming Phase I/IIa clinical trial. These data were specifically requested by the FDA prior to initiating the BriaVax™ trial. Importantly, the data demonstrate that the first lot of BriaVax™ meets all purity, identity, potency and safety requirements for use in patients. The FDA is allowed thirty days to review and respond to the Company’s submission.