Endo Pharmaceuticals, Bioniche’s licensing partner, was conducting the randomized, active-controlled trial.
According to Bioniche, the study was not being recruited at the anticipated rate and subsequent to the discussions with FDA about the trial design, Endo resolved to terminate the study.
The open-label, multi-center study was designed to compare Urocidin with mitomycin C in the intravesical treatment of BCG recurrent or refractory non-muscle-invasive bladder cancer patients.
Bioniche Life Sciences president and CEO Graeme McRae said the discontinuation of the trial is the best decision given the circumstances.
"We are working with Endo to determine the next steps for the Urocidin clinical program in order to build on the successful outcome of the first Phase III trial and to continue to work toward regulatory approval for this important and much-needed therapy," McRaea added.
Both the companies are working together to determine the next steps for the Urocidin clinical program.