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Bioniche Presents MCC Data at the SIU World Uro-Oncology Update in Santiago, Chile
Date:11/24/2008

dy. Thirty-one urology centres in North America are participating and enrolment is expected to be completed in the first quarter of calendar 2009.

BCG, the standard of care for non-muscle-invasive bladder cancer, has limited efficacy, especially as second-line therapy. It is associated with a number of treatment-limiting side effects that include the potential for both local (bladder) and systemic mycobacterial infections. Elderly patients do not seem to respond as well to BCG treatment and are more prone to adverse events.

The refractory to BCG 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 31st site was validated in June, 2008.

Bioniche is planning to conduct a second registration trial which will directly compare the efficacy and safety of MCC with BCG in the treatment of non-muscle-invasive bladder cancer. In September, 2007, the Company announced that an agreement has been reached with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure on the design of the trial, 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). An SPA gives a clear pathway to registration of MCC when the trial endpoints are achieved. This study received Fast Track designation by the FDA earlier this year.

About MCC

MCC is a sterile mycobacterial cell wall-DNA complex 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 trans-urethral catheter directly into the bladder, coming into contact with immune system cells a
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SOURCE Bioniche Life Sciences Inc.
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