BriaCell Therapeutics Moves towards Phase I/IIa Study of BriaVax™

BriaCell Therapeutics Corp (OTCQB:BCTXF) (TSX VENTURE:BCT) is moving towards the final stages of preparation for its upcoming Phase I/IIa study of BriaVax™.
According to the press release:

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.
“We are excited to have made this crucial advance towards initiating the clinical trial of BriaVax™,” said Joseph Wagner, Ph.D., President and CEO of BriaCell. “Our first lot of BriaVax™ intended for patient use in the upcoming study has passed all testing required by FDA and we anticipate receiving approval to initiate the clinical trial by October 31. This first lot of BriaVax™ contains sufficient amounts to initiate the trial and treat multiple patients; additional lots are currently being manufactured so that we will have adequate material to both complete the clinical trial and support research and development work of BriaDx™, our companion diagnostic test. “

Click here to read the full press release.