Endo Pharmaceuticals and Bioniche Life Sciences today presented Phase III trial results for the intravesical formulation of Mycobacterial cell wall-DNA complex (MCC), known as Urocidin™, during a podium presentation at the 2011 American Urological Association annual meeting in Washington, D.C. The preliminary results from the interim analysis of this prospective trial indicate that Urocidin™ may provide an alternative to cystectomy for patients with bacillus Calmette-Guerin (BCG) refractory non-muscle invasive bladder cancer (NMIBC).
The preliminary results were generated from an interim analysis in an ongoing Phase III trial with Urocidin™ in the treatment of NMIBC that is refractory to BCG and at high risk of progression.
The Results
A total of 129 patients were enrolled from 25 centers in the U.S. and Canada, with high grade papillary tumors and/or carcinoma in situ (CIS) and having failed to respond to one or more courses of BCG. According to the preliminary results the overall one-year disease-free survival (DFS) rate was 25 percent. DFS is defined as lack of recurrence or progression to muscle-invasive disease, as confirmed by biopsy. The one-year DFS rate was 35 percent for patients with only papillary tumors and 21 percent for patients with carcinoma in situ (CIS) with or without papillary tumors. The preliminary results indicate that intravesical administration of Urocidin™ was well tolerated.
Ongoing Phase III Clinical Program with Urocidin™
Summary details of a Phase III clinical trial protocol with Urocidin™ being conducted by Endo are publicly available via the U.S. National Institutes of Health (NIH) clinical trial registration service at http://www.clinicaltrials.gov. This trial is actively enrolling eligible NMIBC patients.
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