Bioniche Life Sciences has received US FDA fast track designation for Urocidin for first-line non-muscle-invasive bladder cancer therapy.
Bioniche plans to start a Phase III clinical trial comparing Urocidin, to the current standard therapy in patients with non-muscle-invasive bladder cancer at high risk of recurrence or progression, later in 2008. A biopharmaceutical company that discovers, develops, manufactures, and markets proprietary products for human and animal health markets worldwide
The trial aims to demonstrate non-inferior efficacy with respect to disease-free survival and fewer toxicities than the current therapy. The trial, a double-blind and randomized study, will enroll approximately 800 patients in North America, Australia and Europe.
Graeme McRae, president & CEO of Bioniche, said that it highlights the need for a safer and more effective therapy for first-line bladder cancer patients.