SOURCE: BriaCell Therapeutics Corp.

BriaCell Therapeutics Corp.

March 10, 2015 10:35 ET

BriaCell Therapeutics Submits Phase-I/II Protocol to the US FDA

Planned Clinical Trial to Include Additional Cancer Types

BEVERLY HILLS, CA--(Marketwired - March 10, 2015) - BriaCell Therapeutics Corp (TSX VENTURE: BCT) ("BriaCell", the "Company", or "BCT"), an immuno-oncology focused biotechnology company with a proprietary vaccine technology (BriaVax™), is pleased to announce that the Company has submitted its Phase-I/II Clinical Protocol to the US FDA, with formal provisioning to allow testing of select additional cancer types.

The Company is planning to advance its cancer immunotherapy technology, BriaVax™, in an FDA Phase-I/II clinical trial with up to 24 cancer patients with advanced stages of solid tumors. Although BriaCell's promising results to date have been achieved in late-stage breast cancer patients, the Company recognizes that its technology may be applicable to certain other similar solid cancers as well. The protocol submitted to the FDA for BriaCell's upcoming clinical trial thus has formal provision to allow testing of BriaVax™ in selected patients with other cancers aside from breast, including prostate, ovarian, pancreas, lung and bladder cancers among others. While the core focus in the upcoming clinical trial will remain breast cancer patients, the Company believes that including certain patients of other cancer types could open the door for further expansion of the potential applications of BriaVax™.

BriaCell's Chief Medical Officer Dr. Charles Wiseman has been an oncologist for 40 years, working on a variety of cutting edge cancer treatments and clinical trials, including having initiated the first of its kind breast cancer vaccine studies for MD Anderson Cancer Center. After decades of working on an array of clinical trials for investigational cancer treatments within hospitals and research institutions, Dr. Wiseman chose BriaVax™ as the most promising technology to devote the remain of his career. Dr. Wiseman commented, "We are pleased to have completed and submitted the protocol to the FDA. This is one of the major milestones in advancing towards our clinical trial, and our scientific team worked diligently to make sure we had a polished protocol completed on budget and on time. More importantly, this upcoming clinical trial will hopefully allow us to test BriaVax™ in certain other solid tumors, aside from our central focus of breast cancer. My sincere hope is that BriaVax™ has the potential to demonstrate results not only in breast cancer patients, but other similar solid tumors as well. To start getting facts on the ground as soon as possible, we decided to open the option of including such patients in the upcoming Phase-I/II".


Since the closing of the Company's go-public 3 months ago, the team at BriaCell has been working diligently on advancing a variety of initiatives, including adding to its scientific team and more recently, enhancing investor relations. The Company provides a brief update on some of its key initiatives.

BriaCell has successfully secured a laboratory within the Pasadena Bioscience Collaborative (PBC), a biotech incubator known for providing select promising companies with access to cutting edge medical facilities. This provides BriaCell immediate access to an already established laboratory within a reputable incubator, as opposed to the time, cost, and long-term commitment typically required to construct a new lab. At PBC, BriaCell is amongst a peer group of top-tier biotechs in a collaborative environment, a model which has been shown to encourage innovation. In addition, PBC provides unique access to its own staff of specialized experts such as bioinformatics, cell culture and molecular biology advisors. This structure allows BriaCell easy access to otherwise costly facilities, equipment, and expertise, and is thus in line with the Company's capital disciplined approach. The Company wishes to thank PBC for its belief in BriaCell's promise and for providing BriaCell with these resources and opportunities. This in no way changes the Company's plans of maintaining its current presence at the Beverly Hills Cancer Center, where BriaCell also plans on housing its upcoming clinical trial with Principal Investigator Dr. Steven J. O'Day.

Additionally, the Company reports that it has been in discussions with several prominent hospitals with regards to manufacturing BriaVax™ for its planned clinical trial. As always, the Company is committed to partnering with the most reputable organizations in order to best advance its technology. On this, Dr. Wiseman commented, "I believe that establishing relationships and partnerships with the best names in the space will serve the Company well in the long run. It is no surprise that companies able to establish key relationships in their earlier stages, tend to execute further significant partnerships with these same institutions later down the line." BriaCell hopes to be in a position to report further on this in the near future.


BriaCell is an immuno-oncology focused biotechnology company that has demonstrated unique and unprecedented clinical results, and is intent on building upon these results to further advance BriaVax™ through the FDA clinical trials in order to help cancer patients with no other options. The results of two FDA Phase I clinical trials have been highly promising in terms of both safety and efficacy in patients with advanced, stage-IV breast cancer.

Most uniquely, BriaCell has achieved these results in patients who had prior failed all other available therapies including various kinds of chemotherapy. In some cases, the lifespan was five times longer than expected. The results were targeted, with little to no side effects, and were achieved rapidly, with regression occurring within 6 weeks.

BriaCell's founder, Dr. Charles Wiseman, is a renowned expert in the realm of cancer treatments, having been one of the pioneers of chemotherapy. He then turned his attention to immunotherapies, long before immunotherapies were considered a viable possibility. Dr. Wiseman has authored 100+ papers, articles and medical text-book chapters. Complementing Dr. Wiseman is a team of doctors and scientists, including the recently appointed Principal Investigator for BriaCell's upcoming clinical trial, Dr. Steven J. O'Day. Dr. O'Day has a history of leading successful clinical trials, having been educated and trained at Harvard, Johns Hopkins, and Oxford.  

The team at BriaCell is working towards aggressively advancing BriaVax™ into the next Phase-I/II clinical trial which will include up to 24 additional late-stage cancer patients. For further information and for updated investor presentation, please refer to Company's website:

Cautionary Note on Forward Looking Statements

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, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors - including the availability of funds, the results of financing efforts, the results of exploration activities -- that could cause actual results to differ materially from the Company's expectations are disclosed in the Company's documents filed from time to time on SEDAR (see 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. This press release does not constitute an offer to sell or a solicitation of an offer to sell any of the securities described herein in the United States or elsewhere. These securities have not been, and will not be, registered in the United States Securities Act of 1933, as amended, or any state securities laws, and may not be offered or sold in the United States or to U.S. persons unless registered or exempt therefrom.

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