Bioniche Life Sciences, a research-based biopharmaceutical company, has completed recruitment in its initial Phase III registration trial evaluating Urocidin in the treatment of non-muscle-invasive bladder cancer that is refractory to the current standard immunotherapy – Bacillus Calmette-Guerin.
In this FDA-approved and fast track designated trial, 105 evaluable patients with non-muscle-invasive bladder cancer received Urocidin in an open label trial.
Bioniche said that data from the full cohort of evaluable patients from this trial, coupled with additional safety information to be collected from a second clinical trial that will start later in 2009, will be used to support regulatory submissions under the FDA’s accelerated approval program.
Bioniche plans to conduct a second registration trial that will directly compare the efficacy and safety of Urocidin with Bacillus Calmette-Guerin in the first-line treatment of non-muscle-invasive bladder cancer.
Francois Charette, chief medical officer of Bioniche, said: We are pleased to have achieved this milestone with the enthusiastic support of the clinical investigators. We look forward to having efficacy and safety data available to share with urologists.