The study now underway uses the company’s proprietary Mycobacterial Cell Wall-DNA Complex (MCC – trademarked Urocidin) for the treatment of bladder cancer in patients who are unresponsive or refractory to Bacillus Calmette-Guerin (BCG), the current standard therapy. BCG therapy can result in treatment-limiting side effects in some patients.
The FDA approved the company’s refractory study and subsequently granted it Fast Track designation this year. As a result Bioniche can expect an expedited review by the FDA following completion of the study.
The refractory study is the first of two studies in the company’s phase III bladder cancer program. The company expects to start its second phase III clinical trial in comparing Urocidin to BCG for treatment-naive bladder cancer patients in 2007. Bioniche commented that it expected the study to demonstrate that Urocidin is superior to BCG in terms of safety and is at least as efficacious.