U.S. FDA Grants Fast Track Designation for Bioniche Bladder Cancer Product
Bioniche Life Sciences Inc. announced that the U.S. food and Drug Administration (FDA) has granted Fast Track designation for the Company's proprietary Mycobacterial Cell Wall-DNA Complex (MCC - trademarked Urocidin) for the treatment of non-muscle invasive bladder cancer in patients who are refractory (unresponsive) to Bacillus Calmette-Guérin (BCG), the current standard therapy. BCG is a live, attenuated strain of Mycobacterium bovis, a therapy that is often associated with treatment-limiting side effects. This FDA Fast Track designation means that, when data from the Phase III program becomes available, the Company could expect an expedited review of its biologics Licensing Application for Urocidin.
The refractory trial is one of two trials in Bioniche's Phase III program with Urocidin. The second will involve approximately 630 patients in a randomized, double-blind multi-centre trial comparing Urocidin to BCG as first-line therapy in non-muscle invasive bladder cancer at high risk of recurrence or progression. This trial will be conducted in North America and Europe.
Mycobacterial Cell Wall-DNA Complex (MCC) is formulated from Mycobacterium phlei, a non-pathogenic strain of mycobacteria. MCC has been shown to have immune stimulatory and apoptosis activity against cancer cells. The product is a sterile biological composition in a sub-micron suspension. Urocidin is produced at the Bioniche manufacturing facility in Pointe-Claire, Quebec.
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