Bioniche Life Sciences, a research-based Canadian biopharmaceutical company, has opened enrollment in all centers involved in its North American clinical trial program assessing Urocidin (mycobacterial cell wall-DNA complex) in patients with non-muscle-invasive bladder cancer refractory to current standard therapy. This indication was given fast-track designation by the US Food and Drug Administration in April of 2006.
The full complement of 25 sites which are part of the program has now been fully qualified to enroll patients. Bioniche's clinical team, therefore expects recruitment to be complete towards the end of calendar 2007. The targeted enrollment of this study is 105 patients which, coupled with additional safety information collected from a comparative trial, will allow full results to be reported one year after recruitment is completed for the efficacy and safety datasets, the firm noted.
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