Bioniche receives fast track for bladder cancer therapy

Mar 6 2008

Bioniche Life Sciences Inc. has 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 development 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.