BERKELEY, CA and VANCOUVER, BC–(Marketwired – April 05, 2016) – BriaCell Therapeutics Corp. (“BriaCell” or the “Company”)(TSX VENTURE: BCT) (BCTXF) is very pleased to provide an update in regard to the planned timing of its Phase I/II clinical trial for up to 24 late-stage cancer patients. BriaCell has spent a great deal of time and effort in preparing for the anticipated Phase I/II clinical trial.
Based upon the Company’s current discussions with its partners, BriaCell believes it will be in a position to launch the trial within this current quarter. The Company is working diligently on a number of key initiatives including completion of its vaccine manufacturing, coordinating clinical sites, and finalizing its Contract Research Organization (CRO). The Company hopes to provide further updates on all fronts in the near future.
Dr. Babaei, Chairman of the Board noted, “BriaCell is now in the final stages of preparations for its clinical trial with its lead cancer vaccine, BriaVax™. BriaCell is excited about entering the clinic in order to dose patients and hopefully expand upon its Phase I results. Additionally, the trial will serve to advance BriaCell’s R&D platform through utilizing future BriaVax™ data in complementing its existing gene signature announced last week. We will continue to take steps to work with partners and contractors who can meet our demanding standards and timelines.”
Manufacturing of the vaccine is nearing completion at the facilities of BriaCell’s partner, University of California Davis. As prior noted, UC Davis is manufacturing compliant cGMP-grade BriaVax™ which will be used in dosing patients during the upcoming trial. The Company has already been notified that several BriaVax batches have been completed, and hopes to report further on this matter in the coming weeks.
Upon receiving FDA authorization 5 months ago, BriaCell embarked on identifying a suitable CRO partner in order to facilitate the trial. The Company is at the final stages of negotiations and hopes to report further on this within the coming weeks.
BriaCell has been in discussions with potential sites at which it would recruit and dose patients during its Phase I/II. These sites are primarily university-hospitals with large patient populations who might be matches for BriaCell’s trial. BriaCell hopes to update further on this matter in the near future.
BriaCell is an immuno-oncology biotechnology company which recently received FDA authorization to advance into a Phase I/II clinical trial for advanced breast cancer and possibly other cancer types.The Company has demonstrated unique highly promising results, wherein certain patients saw 3-5x survival vs. typical life expectancy for Stage-IV breast cancer patients. BriaCell is intent on building upon these results to further advance BriaVax™ through FDA Clinical Trials in order to help cancer patients with no other options. The results of two FDA Phase-I clinical trials, one conducted using BriaVax™, the other using a related vaccine, have been encouraging in terms of both safety and efficacy in patients with advanced 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 survival 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.
In one patient, cancer regressed at all sites, including lesions in the breast, lung, and even brain. Again, results were seen rapidly and with little to no adverse side effects.
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