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Bioniche Receives Fast Track Designation For First-Line Bladder Cancer Therapy
Date:3/4/2008

t program with Urocidin," said Graeme McRae, President & CEO of Bioniche Life Sciences Inc. "It highlights the need for a safer and more effective therapy for first-line bladder cancer patients. The FDA clearly recognizes that the current approved therapy is less than satisfactory, and wishes to expedite the introduction of new therapies."

In September, 2007, the Company announced that an agreement had been reached with the FDA under the Special Protocol Assessment (SPA) procedure for this Phase III trial of Urocidin as a first-line therapy. An SPA provides assurance that, if the proposed endpoints are met, they will serve as the basis for approval of the product as part of a Biologics Licensing Application (BLA). An SPA gives a clear pathway to registration of the product when the study endpoints are achieved.

Bioniche plans to begin recruitment of patients for this second pivotal study later this year. The study currently plans to enrol approximately 800 patients in North America, Australia and Europe and is a double-blind, randomized study. It will compare MCC to the standard treatment for non muscle-invasive bladder cancer at high risk of recurrence or progression - Bacillus Calmette-Guerin (BCG). BCG is a live, attenuated strain of Mycobacterium bovis and is often associated with treatment-limiting side effects including active bacterial infections.

The Company also continues to enroll patients in its first Fast Track Phase III clinical trial with Urocidin. When fully enrolled, this trial will involve 105 patients in North America with non muscle-invasive bladder cancer that is refractory to BCG. The Company reported last month that the Data Safety Monitoring Committee held its third scheduled quarterly meeting regarding this clinical trial, after which it recommended that Bioniche "continue the trial unmodified until the next scheduled or triggered meeting." The next meeting of the Committee will be held in May, 2008.

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