BIONICHE BEGINS STUDY OF UROCIDIN IN BLADDER CANCER

Bioniche Life Sciences announced the first patient in its Phase III trial of Urocidin for refractory bladder cancer has been treated.

The FDA approved the company's refractory, open-label study in February and granted the drug fast-track designation in April. This means that Bioniche can expect an expedited review by the FDA following completion of the study. The refractory study is the first of two studies in the company's Phase III bladder cancer program. Bioniche expects to start its second Phase III clinical trial -- comparing Urocidin with Bacillus Calmette-Guerin (BCG) in treatment-naïve, non-muscle-invasive bladder cancer patients (first-line therapy) -- in 2007. This study will involve more than 600 patients in North America and Europe. It is expected that this study will demonstrate that Urocidin is superior to BCG in terms of safety and is at least as efficacious.

The current study uses the company's proprietary mycobacterial cell wall-DNA complex (Urocidin) for the treatment of non-muscle-invasive bladder cancer in patients who are refractory (unresponsive) to BCG, a live, attenuated strain of Mycobacterium bovis and the current standard therapy. BCG therapy can result in treatment-limiting side effects in some patients, according to Bioniche.

Mycobacterial cell wall-DNA complex (MCC) is a composition prepared from Mycobacterium phlei, a saprophytic mycobacterium. MCC has immune stimulatory as well as apoptosis-inducing activity against cancer cells. Urocidin is a formulation of MCC for the treatment of high-grade, non-invasive bladder cancer.