BIONICHE GETS FDA APPROVAL FOR BLADDER CANCER TRIALS
Bioniche Life Sciences has announced that the FDA has given approval to proceed with the second of two Phase III clinical trials using the company's proprietary mycobacterial cell wall-DNA complex (MCC) for the treatment of bladder cancer, Urocidin.
The second Phase III trial will involve approximately 630 patients in a randomized, double-blind multi-centre trial comparing Urocidin to Bacillus Calmette-Guerin (BCG) as first-line therapy in non-muscle invasive (superficial) bladder cancer at high risk of recurrence or progression. BCG is a live, attenuated strain of Mycobacterium bovis that is the current standard therapy for bladder cancer, but is a treatment that is often associated with treatment-limiting side-effects. The Bioniche study will be conducted in North America and Europe.
The first Phase III trial will be carried out at the same time as the second. It will involve 105 patients in an open-label study showing the efficacy of Urocidin as therapy in non-muscle invasive bladder cancer that is refractory (unresponsive) to BCG. This study will be conducted in North America.