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FDA Grants Fast Track Designation to Mycobacterial Cell Wall-DNA Complex, Bladder Cancer Treatment
Bioniche announced in February that the FDA approved its Phase III clinical trial with Urocidin in the treatment of this patient population. This is an open-label study involving 105 North American patients to demonstrate the efficacy of Urocidin as a therapy in non-muscle invasive bladder cancer refractory to BCG.
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.
"This is very positive news," said Graeme McRae, President & CEO of Bioniche Life Sciences Inc. "A large number of patients don't respond to BCG - - approximately 35% -- and have not previously had a satisfactory alternative treatment beyond bladder removal, an invasive and life-altering surgery. This designation gives us great confidence that Urocidin will be available to uro- oncologists for their refractory patients at the earliest possible opportunity."
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.
Patient enrolment for the Phase III program is expected to commence by mid-2006.
About Urocidin (MCC)
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 (programmed cell death) 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.
Source: Bioniche Life Sciences Inc.