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

- Second Phase III clinical trial to begin later this year -

BELLEVILLE, ON, March 4 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that its therapy for first-line non-muscle-invasive bladder cancer meets the criteria for Fast Track designation. A Phase III clinical trial comparing a formulation of the Company's Mycobacterial Cell Wall-DNA Complex (MCC) - Urocidin(TM) - to the current standard therapy in patients with non-muscle-invasive bladder cancer at high risk of recurrence or progression. This clinical trial, scheduled to begin later in 2008, aims to demonstrate non-inferior efficacy with respect to disease-free survival and fewer toxicities than the current therapy.

This is the second Phase III trial of the Company to receive Fast Track designation: Bioniche's registration trial of Urocidin for bladder cancer patients that have failed current therapies was designated as Fast Track in April, 2006. That first "Refractory" Phase III trial is ongoing at leading bladder cancer centres across Canada and the United States.

The designation of a product/indication as Fast Tracked means that the FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product. The FDA may also evaluate for filing and commence review of portions of an application for approval of a Fast Track product under certain conditions. The potential for expedited review and the ability to file submission documents on a rolling basis can serve to accelerate final product approval. In its letter of notice, the FDA indicated, "We look forward to working with you to expedite the development and review of this promising proposed use of the product."

"This is an important milestone for our Phase III clinical developmen
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SOURCE Bioniche Life Sciences Inc.
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