Bioniche Life Sciences Inc., a research-based biopharmaceutical company, has announced that a second Phase III clinical trial with Urocidin in non-muscle-invasive bladder cancer is being discontinued.
The trial, 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, was being run by the company's global licensing partner, Endo Pharmaceuticals (Endo), a subsidiary of Endo Health Solutions.
The trial has not been recruiting at the expected rate and, after recent discussions with the FDA regarding the current clinical trial design, Endo has decided to end the study before its scheduled completion. Endo and Bioniche are jointly considering potential next steps for the program.
Urocidin is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. Urocidin is formulated for the treatment of bladder cancer, where it is administered by trans-urethral catheter directly into the bladder. The agent is then able to directly interact with the cells of the immune system and bladder cancer cells.
"We are disappointed with this outcome, but we believe it is the best decision given the circumstances," said Mr Graeme McRae, president & CEO of Bioniche Life Sciences Inc. "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."