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

7, the Company announced that an agreement had been reached with the 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 Urocidin when the trial endpoints are achieved. This indication for MCC received Fast Track designation by the FDA last year. The Company expects to start this trial at such time as it has a development and marketing partner in place.

About Bladder Cancer

In North America, bladder cancer is the fourth most common cancer in men and in the top ten for women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year. In addition, the cancers of many previously-diagnosed patients remain unresolved, sometimes leading to cystectomy (bladder removal) or death. Approximately 70% bladder cancer patients have the non-muscle-invasive form of bladder cancer at diagnosis and, on appropriate regulatory approvals, might be eligible for multiple treatments with Urocidin.

Non-muscle-invasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.

About Urocidin(TM)

Urocidin is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. Urocidin is formulated for the treatment of bladder cancer, where it is administered by trans-urethral catheter
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SOURCE Bioniche Life Sciences Inc.
Copyright©2009 PR Newswire.
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Related medicine news :

1. Bioniche Reports Fiscal 2009 Third Quarter
2. Bioniche Provides a Corporate Update
3. Bioniche Completes Recruitment in First Phase III Clinical Trial with Urocidin(TM)
4. Bioniche Revolving Credit Facility Maturity Date Amended
5. Bioniche Phase II Bladder Cancer Trial Results Published in The Journal of Urology
6. Bioniche Warrants Expiration Date to be Extended
7. Bioniche Reports Fiscal 2009 Second Quarter
8. Bioniche Invited to Participate in Canadian Beef Value Chain Roundtable
9. Bioniche Named One of the Top 50 Best Small and Medium Employers in Canada
10. Bioniche Presents MCC Data at the SIU World Uro-Oncology Update in Santiago, Chile
11. Bioniche Reports Fiscal 2009 First Quarter
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