Bioniche Granted Fast Track Status for Bladder Cancer Therapy
Posted on: Wednesday, 5 March 2008, 06:00 CST
Bioniche Life Sciences has received 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. 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: "This is an important milestone for our Phase III clinical development program with Urocidin. It highlights the need for a safer and more effective therapy for first-line bladder cancer patients."
Source: Datamonitor
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