Positive Release Testing Data From First Lot of Vaccine Submitted to FDA; Contract Negotiations Underway With Initial Clinical Site
BERKELEY, CA and VANCOUVER, BC--(Marketwired - October 08, 2015) - BriaCell Therapeutics Corp (
BriaCell has submitted to the US Food and Drug Administration (FDA) final positive results its first lot of BriaVax™ which is to be used in BriaCell's upcoming Phase I/IIa clinical trial. These data were specifically requested by the FDA prior to initiating the BriaVax™ trial. Importantly, the data demonstrate that the first lot of BriaVax™ meets all purity, identity, potency and safety requirements for use in patients. The FDA is allowed thirty days to review and respond to the Company's submission.
"We are excited to have made this crucial advance towards initiating the clinical trial of BriaVax™," said Joseph Wagner, Ph.D., President and CEO of BriaCell. "Our first lot of BriaVax™ intended for patient use in the upcoming study has passed all testing required by FDA and we anticipate receiving approval to initiate the clinical trial by October 31. This first lot of BriaVax™ contains sufficient amounts to initiate the trial and treat multiple patients; additional lots are currently being manufactured so that we will have adequate material to both complete the clinical trial and support research and development work of BriaDx™, our companion diagnostic test. "
Dr. Wagner continued, "With the FDA submission complete, the Company has now focused on clinical operations, including the selection of our lead clinical trial site and the negotiation of a Clinical Trial Agreement, which is currently underway. Upon FDA approval, our lead Principal Investigator will submit the clinical trial protocol to the sites Institutional Review Board (IRB) for approval. With IRB approval the trial would be officially active and could begin enrolling patients.""
With the above in place, management feels that BriaCell remains well positioned to meet its guidance target date of enrolling first clinical patients during Q4 of this year. A potential added benefit of protocol activation could be additional non-dilutive grant eligibility, which the Company will pursue aggressively.
BRIACELL NEW OTC TICKETR: BCTXF
In addition, the Company also announces that, effective October 6, BriaCell's new US OTC-QB ticker symbol has been changed to BCTXF, in order to more closely align the US symbol with the ticker symbol used on the TSX Venture exchange.
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.
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 than expected. The results were targeted, with little to no side effects, and were achieved rapidly, with regression occurring within 6 weeks.
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
BriaCell wishes to announce its intention to issue options in the company. Such options will be in line with the Company's option plan approved by shareholders. It is anticipated that such options will be allocated to various members of BriaCell's executive team, board, consultants and advisors.
BriaCell believes options are an instrumental component in retaining top talent, particularly given the Company's stage, and the ability for larger firms to offer larger cash salaries.
Options have the benefit of aligning and incentivizing key individuals with BriaCell's long term value creation mission given that an option's value is earned through an appreciating share price.
It is anticipated that 4-million options will be issued, such options being exercisable for a period of between 2 to 10 years, at a price of $0.255. The duration will vary on a case by case basis as evaluated by BriaCell's compensation committee. This remains subject to TSX Venture approval.
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.
Embedded Video Available: https://youtu.be/el-yFF1uHoQ
For further information contact:
BriaCell Therapeutics Corp.
820 Heinz Avenue
Berkeley, CA 94710
Joseph Wagner, Ph.D.
President and CEO