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Bioniche Phase III Clinical Trial with Urocidin(TM) Progressing Well
Date:5/22/2009

BELLEVILLE, ON, May 22 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. ("Bioniche"; TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today provided an update on its Phase III clinical program evaluating Urocidin(TM) in the treatment of bladder cancer. On March 31st, the Company announced that recruitment had been completed in its initial Phase III registration trial evaluating Urocidin in the treatment of non-muscle-invasive bladder cancer that is refractory (unresponsive) to the current standard immunotherapy - Bacillus Calmette-Guerin (BCG).

The Data Safety Monitoring Committee (DSMC) held its eighth meeting regarding this clinical trial earlier this week. After its meeting, the Committee has recommended that Bioniche "continue the trial unmodified until the next scheduled or triggered meeting." The next scheduled meeting of the Committee is July.

The DSMC is an independent group that acts in an advisory capacity to the Company. Its role is to evaluate the progress of the clinical trial, including monitoring the safety and efficacy data generated in the trial. On a regular basis, the DSMC reviews study results, evaluates the incidence of adverse events, determines whether the basic trial assumptions remain valid, and evaluates whether the overall integrity, scientific merit and conduct of the study remain acceptable.

Data from the full cohort of 105 high-grade bladder cancer patients from this trial, coupled with additional safety information to be collected from a second clinical trial that is expected to start later this year, will be used to support regulatory submissions under the FDA's Accelerated Approval program.

Second Phase III Registration Trial

Bioniche plans to conduct a second registration trial that will directly compare the efficacy and safety of Urocidin with BCG in the first-line treatment of non-muscle-invasive bladder cancer. In September, 200
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SOURCE Bioniche Life Sciences Inc.
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2. Bioniche Provides a Corporate Update
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5. Bioniche Phase II Bladder Cancer Trial Results Published in The Journal of Urology
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