Endo Pharmaceuticals and Bioniche Life Sciences have enrolled the first patient in the second phase III clinical trial of Urocidin.
The trial is a randomized, active-controlled, open-label, multi-center study with a blinded endpoint assessment designed to compare Urocidin with mitomycin C in the intravesical treatment of patients with BCG recurrent or refractory non-muscle-invasive bladder cancer. About 450 patients are enrolled for this new trial at 120 clinical sites worldwide.
Urocidin is a mycobacterial cell wall-DNA complex (MCC) that has a dual mode of action: immune stimulation and direct anticancer activity. It treats bladder cancer by trans-urethral catheter injections directly into the bladder. MCC then interacts with the cells of the immune system and bladder cancer cells.