Current Urocidin Phase III trial discontinued
Bioniche Life Sciences has reported that a second Phase III trial with Urocidin in non-muscle-invasive bladder cancer is being discontinued.
The trial, a randomised, active-controlled, open-label, multi-centre 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, was being run by the company's global licensing partner, Endo Pharmaceuticals (Endo Health Solutions).
The trial has not been recruiting at the expected rate and, after recent discussions with the FDA regarding the current trial design, Endo decided to end the study before its scheduled completion. Endo and Bioniche are jointly considering potential next steps for the programme.