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.
BriaCell is a cancer immunotherapy biotechnology company developing a more targeted, less toxic approach to management of cancer. Immunotherapies have come to the forefront of the fight against cancer, because they harness the body's own immune system in recognizing and selectively destroying the cancer cells, sparing normal ones. Immunotherapies, in addition to generally being more targeted and less toxic, have been shown to be more likely to prevent recurrence and are not expected to produce the serious side effects seen with chemotherapy.
BriaVax™, 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 no other 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, patient survival was three to five times longer than would have been expected.
The TSX Venture Exchange Inc. has in no way passed upon the merits of the Company has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. This news release contains forward-looking information, which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors -- including the availability of future financing, the results of clinical trials, and need for further FDA approvals -- that could cause actual results to differ materially from the Company's expectations are more particularly described in the Company's public filings on SEDAR (see www.sedar.com). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.