Bladder Cancer

U.S. FDA grants fast track status for mycobacterial cell wall-DNA complex for bladder cancer

Published in Medical Letter on the CDC and FDA, May 31st, 2006

Bioniche Life Sciences Inc. (BNC) announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for the company's mycobacterial cell wall-DNA complex (MCC, Urocidin) for the treatment of nonmuscle invasive bladder cancer in patients who are refractory to Bacillus Calmette-Guerin (BCG), the current standard therapy.

BCG is a live, attenuated strain of mycobacterium bovis, a therapy that is often associated with treatment-limiting side effects.

Bioniche announced in February that the FDA approved its phase 3 clinical trial with Urocidin in the treatment of this patient population. This is an open-label study...

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Source: Medical Letter on the CDC and FDA (2006-05-31)

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