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August 19, 2014
Bioniche Announces Q1/2015 Timeline for the Filing of a Biologics License Application for Marketing Approval of MCNA in the United States

July 29, 2014
Bioniche Announces Submission of Orphan Drug Designation Application for MCNA in the United States

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Clinical Trials

Understanding Clinical Trials  |  Glossary of Key Terms

Urocidin™ - a suspension of MCNA - is currently being tested in a Phase III clinical program in bladder cancer. The first trial was conducted by Bioniche involving 129 patients with non-muscle-invasive bladder cancer that was refractory (unresponsive) to the current standard therapy – BCG. This trial was an open label, single-arm trial, meaning there was no comparator therapy used in the trial. This design was ethical and permitted by regulators and ethics committees due to the fact that no approved therapy was available for patients with non-muscle-invasive bladder cancer who failed prior BCG therapy.

The Company identified a goal of achieving a clinically meaningful complete response rate with a safety measure of less than 10% of patients unable to tolerate treatment. This trial enrolled its first patient in November, 2006 and the last patient was enrolled in April, 2009.  The preliminary results were reported at urology association meetings in March, May and June, 2011.

In terms of efficacy, the trial resulted in a 12-month 25% disease-free survival outcome. The therapy was well-tolerated, with most adverse events being mild to moderate.

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