News: BriaCell files phase I/II protocal with U.S. FDABriaCell files phase I/II protocal with U.S. FDA 2015-03-10 10:43 ET - News Release Dr. Charles Wiseman reports BRIACELL THERAPEUTICS SUBMITS PHASE-I/II PROTOCOL TO THE US FDA BriaCell Therapeutics Corp. has submitted its phase I/II clinical protocol to the United States Food and Drug Administration, 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 tumours. 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 toward 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 tumours, 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 tumours 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." General update Since the closing of the company's go public three 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 advisers. 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 regard 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. We seek Safe Harbor. © 2015 Canjex Publishing Ltd. All rights reserved.