Healthcare Industry News: bladder cancer
News Release - May 4, 2006
U.S. FDA Grants Fast Track Designation for Bioniche Bladder Cancer Productdesignation expected to speed access to refractory bladder cancer market
BELLEVILLE, ON, May 4 (Healthcare Sales & Marketing Network) - Bioniche Life Sciences Inc. (TSX: BNC ), a research-based, technology-driven Canadian biopharmaceutical company, today 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.
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.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs approximately 185 skilled personnel and has three principal operating divisions: Human Health, Animal Health, and Food Safety. The Company's primary goal is to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health. For more information, please visit www.Bioniche.com.
Except for historical information, this news release may contain forward-looking statements that reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
Source: Bioniche Life Sciences
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