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Bioniche Provides Update on Refractory Bladder Cancer Trial with Urocidin(TM)
Date:2/13/2008

ny announced that an agreement has been reached with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure. This indicates agreement by the FDA on the design of the study, including its endpoints, data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a Biologics Licensing Application (BLA). A SPA gives a clear pathway to registration of Urocidin when the study endpoints are achieved.

Bioniche plans to begin recruitment of patients for the second pivotal study later this year. The study will 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.

Bioniche also continues to have discussions with potential development and marketing partners, and the Company is well positioned and committed to execute a strategic partnership transaction related to the financing of Urocidin at the earliest opportunity.

About MCC

MCC is a sterile mycobacterial cell wall composition that has a dual mode of action: immune stimulation and direct anticancer activity. It is formulated as Urocidin(TM) for the treatment of bladder cancer, where it is administered by the intravesical route directly into the bladder, coming into contact with immune system cells and bladder cancer cells. MCC is also undergoing preclinical evaluation as a treatment for peritoneal carcinomatosis associated with colon and ovarian cancer.

About Bioniche Life Sciences Inc.

Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused
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SOURCE Bioniche Life Sciences Inc.
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