Bioniche Provides Update on Refractory Bladder Cancer Trial with Ur...( - Data Safety Monitoring Co...),Health

- Data Safety Monitoring Committee holds third meeting -

BELLEVILLE, ON, Feb. 13 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, is pleased to provide an update on the progress of its North American clinical trial with Mycobacterial Cell Wall-DNA Complex (MCC) - trademarked Urocidin - in patients with non muscle-invasive bladder cancer that is refractory to the current standard therapy. This indication was given Fast Track designation by the U.S. Food and Drug Administration (FDA) in April of 2006.

The Company commenced this trial in November, 2006. An investigators' meeting was held in April, 2007, and the trial has been progressing steadily since that time.

On February 7, 2008, the Data Safety Monitoring Committee held its third meeting regarding this clinical trial. The role of this independent body is to confirm that the safety of enrolled patients is being appropriately addressed and that, from an efficacy point of view, there is an appropriate basis for continuing the trial. After its meeting, the Committee has recommended that Bioniche "continue the trial unmodified until the next scheduled or triggered meeting." The next meeting of the Committee will be held in three months.

Patients are being enrolled in the trial's 25 sites on a regular basis. The targeted enrollment of this study is 105 patients which, coupled with additional safety information collected from a comparative trial, will allow full results to be reported one year after recruitment is completed for the efficacy and safety datasets. These results may also support regulatory submissions under FDA's Accelerated Approval program.

Bioniche is planning to conduct a second registration study in bladder cancer; a trial which will directly compare the efficacy of Urocidin with the incumbent therapy for non muscle-invasive bladder cancer. In September, 2007, the Compa
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