In this first part of the phase III program, 105 patients will be involved in an open-label study to evaluate the efficacy of Mycobacterial cell wall-DNA complex (MCC) as a therapy in superficial bladder cancer that has proved unresponsive to treatment with Bacillus Calmette-Guerin (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.
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 study comparing MCC to BCG as first-line therapy in superficial bladder cancer at high risk of recurrence or progression.
“Bladder cancer, our first indication, is a debilitating disease, affecting more than 140,000 people annually in North America and Europe,” stated Graeme McRae, president & CEO.