Bioniche to Begin Phase III Comparative Bladder Cancer Trial

Canadian drugmaker Bioniche Life Sciences announced that it has reached an agreement with the FDA for a Phase III study using the company’s proprietary mycobacterial cell wall-DNA complex in non-muscle-invasive bladder cancer patients who are at risk for disease recurrence or progression.

Bioniche plans to recruit patients for the second pivotal study in the first quarter of 2008. The double-blind, randomized study will enroll approximately 800 patients in North America, Australia and Europe.

The company said the study will compare mycobacterial cell wall-DNA complex with Bacillus Calmette-Guérin, the standard therapy that is often associated with treatment-limiting side effects.

The primary efficacy endpoint will be the duration of disease-free survival of patients after two years, the company added.