BriaCell Therapeutics Announces Positive Response From FDABriaCell Therapeutics Announces Positive Response From FDA and Entry Into a Definitive Agreement to Begin GMP Manufacturing of BriaVax
VANCOUVER, BC--(Marketwired - June 16, 2015) - BriaCell Therapeutics Corp (TSX VENTURE: BCT) ("BriaCell", the "Company", or "BCT") is pleased to announce that the Company has entered into a Definitive Agreement to begin current Good Manufacturing Processes -- ("cGMP") compliant manufacturing of BriaVax™. BriaVax™ is the Company's proprietary cancer immunotherapy being tested in the upcoming Phase I/II clinical trial that will enroll up to 24 patients with advanced stages of cancer. The Company executed the agreement on June 11 as a result of positive feedback from the United States Food and Drug Administration ("FDA") to the Company's response letter dated May 19, 2015. It is anticipated that manufacture of fully qualified, clinical-grade BriaVax™ should be completed during Q3 of this year.
Under the terms of the Agreement for Services with the University of California, Davis Health System ("UC Davis"), the University's Institute for Regenerative Cures will provide a number of services to BriaCell, most notably the cGMP manufacture, quality control and release testing of sufficient amounts of BriaVax™ to support the upcoming clinical trial. In order to avoid scheduling delays, the Company has identified UC Davis as its primary manufacturing site for the current study; the Siteman Comprehensive Cancer Center of Washington University, St. Louis will serve as a backup site, if necessary.
"With the entry into a Definitive Agreement to manufacture BriaVax™, BriaCell continues to progress toward initiating our important clinical Phase I/II clinical study," said Joseph Wagner, Ph.D., President and CEO of BriaCell. "Initiation of GMP manufacturing was dependent on important feedback from the FDA on a number of issues, most importantly the results of stability testing of our BriaVax Master Cell Bank. We now have the clarity we need from the FDA to confidently initiate the final manufacture of clinical-grade material. FDA has requested to review final lot release testing of GMP material prior to initiating the clinical study, which is consistent with my past experience working on cell therapy clinical trials. I look forward to working with our manufacturing site to ensure timely completion of this process and fully anticipate initiating our clinical trial of BriaVax in the early-Q4 timeframe."
ABOUT BRIACELL
BriaCell is a breast cancer immunotherapy biotechnology company. 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 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 encouraging 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 the available therapies including various kinds of chemotherapy. In some cases, the lifespan was three to 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 FDA-approved 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 at www.briacell.com or its youtube channel www.youtube.com/watch?v=el-yFF1uHoQ