VANCOUVER, BC--(Marketwired - May 19, 2015) - BriaCell Therapeutics Corp (TSX VENTURE: BCT), an immuno-oncology focused biotechnology company with a proprietary vaccine technology (BriaVax™), is pleased to announce that it has successfully completed all of the testing requested by the FDA and that it has submitted a formal response including the successful results of such tests.
As announced on March 10, 2015, BriaCell had submitted a complete Phase-I/II Protocol outlining its planned upcoming clinical trial. The FDA responded with a standard request for data on the identity, stability, purity and potency of the BriaVax™ Vaccine. BriaCell proposed a strategy to the FDA through which it would conduct a variety of tests in order to comply, and the FDA commented that BriaCell's proposed quality control strategy would be acceptable.
Therefore, the team at BriaCell proceeded to complete a total of 13 laboratory tests on the BriaVax™ Vaccine, some of which required weeks of monitoring the cells. These tests were recently completed and came back successful in that the results were just as expected. BriaCell's regulatory affairs team immediately compiled the results of such tests in a formal response to the FDA, which has been submitted. The Company received confirmation from the FDA that it has received the package, and anticipates an official response by June 11, 2015.
Dr. Charles Wiseman commented, "The team worked diligently to ensure that we had a strategy in place showing that our Vaccine remains in top shape, and the tests were conducted to the highest possible standards of quality. We are delighted that our BriaVax™ has displayed all the results we had hoped for. I firmly believe that there is significant room to create tremendous value if we keep hitting our milestones as we have the past 6 months, as we continue to shift from a Phase-I company into a more advanced biotech."
CORPORATE UPDATE
The committed team of scientists and executives at BriaCell has been working on advancing a variety of initiatives as the Company progresses towards its planned clinical trial. Operations remain completely on-budget and on-schedule.
Specifically, the Company has been in negotiations with hospitals and medical universities with regards to the manufacturing of BriaVax™ for the upcoming clinical trial. While the Company had prior advanced negotiations with its top candidates, some recent developments utilizing relationships at other institutions have brought forth additional candidates, which the Company believes may offer the potential for an even more attractive partnership, both in terms of timing and economics. The Company believes that the advantages could be very substantial, and hopes to finalize this in the coming weeks.
With regards to its planned clinical trial, as mentioned, BriaCell has now submitted its protocol and subsequent response to the FDA including successful lab tests of quality assurance and control. BriaCell now awaits final FDA approval to proceed with the trial. Pending such approval, the Company reaffirms its target for a launch of Clinical Trial of late Q3 to early Q4 of this year.
The Company has received interest from new European and US investors. Therefore, the Company has listed on the Frankfurt Stock Exchange, symbol 8BT in April, and has also filed to list on the OTCQX. The Company hopes to expand its marketing in these regions as it grows and generates more interest, with the end-goal being an up-list to the NASDAQ.
ABOUT BRIACELL
BriaCell is an immuno-oncology biotechnology company. Immunotherapies have come to the forefront in 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 are believed to be a more targeted, less toxic approach to managing cancer. This approach is also more likely to prevent recurrence and is not expected to produce the serious side effects seen with chemotherapy.
The Company has demonstrated unique and unprecedented 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 expected. The results were targeted, with little to no side effects, and were achieved rapidly, with regression occurring within 6 weeks.
In one patient, cancer regressed in all sites to which the cancer had spread, including lesions in the breast, lung, and even brain. This result was the most unique finding, given that the brain is largely considered an untouchable site in terms of cancer regression. Again, results were seen rapidly and with little to no adverse side effects.
The Company is planning to advance its cancer immunotherapy technology in an FDA Phase-I/II clinical trial with up to 24 breast cancer patients with advanced stages of solid tumors. The submitted protocol has provision to allow testing the vaccine in selected patients with other cancers as well, including prostate, ovarian, pancreas, lung and bladder cancers among others. Although the focus of the Company is currently breast cancer, it recognizes that upon further proof of concept, its technology may be applicable to such other cancers as well. For further information, please refer to Company's website: www.briacell.com or its introductory video at www.youtube.com/watch?v=el-yFF1uHoQ.
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 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. 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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