Dr. Saeid Babaei reports
BRIACELL TARGETING LAUNCH OF ITS PHASE I/II CLINICAL TRIAL DURING CURRENT QUARTER
BriaCell Therapeutics Corp. has provided 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, co-ordinating clinical sites and finalizing its contract research organization (CRO). The company hopes to provide further updates on all fronts in the near future.
Dr. Saeid 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 [research and development] 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 (current good manufacturing practice) BriaVax which will be used in dosing patients during the coming 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 U.S. Food and Drug Administration authorization five 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 clinical trial. These sites are primarily university hospitals with large patient populations that might be matches for BriaCell's trial. BriaCell hopes to update further on this matter in the near future.
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