FDA ACCEPTS BIONICHE'S IND FOR BLADDER CANCER TREATMENT

Bioniche Life Sciences has reported that the FDA has approved its investigational new drug (IND) application for the first of two Phase III clinical trials using the company's proprietary Mycobacterial Cell Wall-DNA Complex (MCC) for the treatment of bladder cancer.

In this first part of the Phase III program, 105 patients will be involved in an open-label study showing the efficacy of MCC as therapy in superficial bladder cancer refractory (unresponsive) to Bacillus Calmette-Gurin (BCG). BCG is a live, attenuated strain of Mycobacterium bovis, the current standard therapy for bladder cancer, but one that is often associated with treatment-limiting side-effects. The study will be conducted in North America. Patient enrolment will commence in the second quarter of 2006.