U.S. FDA Accepts Part One of Bioniche Program for Phase III Clinical Trials with MCC for Bladder Cancer
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Bioniche Life Sciences Inc. announced that the U.S. food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for the first of two Phase III clinical trials using the Company's proprietary Mycobacterial Cell Wall-DNA Complex (MCC) for the treatment of bladder cancer.
In this first part of the Phase III program, 105 patients will be involved in an open-label study showing the efficacy of MCC as therapy in superficial bladder cancer refractory (unresponsive) to Bacillus Calmette-Guérin (BCG). BCG is a live, attenuated strain of Mycobacterium bovis, the current standard therapy for bladder cancer, but one that is often associated with treatment-limiting side effects. This Bioniche study will be conducted in North America. Patient enrolment will commence in the second quarter of calendar 2006. This clinical trial is expected to take between three and four years to complete.
The FDA is currently reviewing the IND for the second part of the Company's Phase III program, in which approximately 600 patients will be involved in a randomized, double-blind, multi-centre study comparing MCC to BCG as first-line therapy in superficial bladder cancer at high risk of recurrence or progression. This study will take place in both North America and Europe.
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