BriaCell Therapeutics Corp.
November 4, 2015 11:01 AM
BERKELEY, CA and VANCOUVER, BC–(Marketwired – November 04, 2015) – BriaCell Therapeutics Corp (BCTXF) (TSX VENTURE: BCT) (“BriaCell”, the “Company”, or “BCT”) is pleased to announce that the U.S. Food and Drug Administration (FDA) has given final clearance for the Company’s Investigational New Drug (IND) application to initiate a Phase I/IIa clinical trial of BriaVax™. The open-label, non-randomized trial will enroll up to 24 breast cancer patients with advanced stages of disease. The clinical trial protocol has the provision to allow testing of the vaccine in selected patients with other cancers as well, including prostate, ovarian, pancreas, lung and bladder cancers among others. Patient enrollment is expected to begin in late 2015 or early 2016, pending the approval by the Principal Investigator’s Institutional Review Board (IRB) and the execution of a final Clinical Trial Agreement with the initial clinical trial site.
“We are very excited to have accomplished this major milestone,” said Joseph Wagner, Ph.D., President and CEO of BriaCell. “Final clearance of the IND means the BriaCell team can focus on what has always been our number one priority: initiating patient enrollment in the BriaVax™ trial. We look forward to reporting the progress of the clinical trial over the coming months.”
Information about the trial will be made available at the ClinicalTrials.gov website of the National Institutes of Health. Additional information will be made available on BriaCell’s website www.briacell.com.