Endo Pharmaceuticals (Nasdaq: ENDP) and Bioniche Life Sciences Inc. (TSX and ASX: BNC) today announced plans for peer-reviewed presentation of interim efficacy and safety results from the first Phase III trial of the intravesical formulation of Mycobacterial cell wall-DNA complex (MCC), known as Urocidin™ or EN3348. The results to be presented have been generated from an ongoing Phase III registration trial with Urocidin™ in the treatment of non-muscle-invasive bladder cancer (NMIBC) that is refractory to current first-line therapy (Bacillus Calmette-Guerin, known as BCG).
The first abstract and poster summaries of such results will be made available during the Annual Congress of the European Association of Urology (EAU) March 18-22 in Vienna, Austria. The accepted abstract is now available to EAU members. Further disclosure of results from this trial will be made during a podium presentation at the annual American Urological Association (AUA) meeting May 14-19 in Washington, D.C.
Phase III Results
The EAU and AUA abstracts highlight results based on an interim analysis of the Phase III trial. The objective of the trial is to evaluate the efficacy and safety of Urocidin™ in patients with non-muscle-invasive bladder cancer (NMIBC) who are refractory to intravesical BCG therapy and at high risk of progression. A total of 129 patients were enrolled from 25 centers in the U.S. and Canada, with high grade papillary and/or carcinoma in situ (CIS) and having failed to respond to one or more courses of BCG. 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 rates, when sub-divided by tumor type (e.g., CIS with or without papillary tumors or papillary tumors alone) at study entry is disclosed in the conference materials, as is the median DFS interval (in days) of the intent-to-treat population. In terms of safety, the results showed that intravesical administration of Urocidin™ was well tolerated, with most adverse events being mild to moderate in severity and few leading to discontinuation of treatment. The authors of the abstract concluded that the interim analysis of this prospective trial indicates that Urocidin™ may provide an alternative to cystectomy for patients with BCG-refractory NMIBC.
Ongoing Phase III Clinical Program with Urocidin™
Summary details of a second Phase III clinical trial protocol 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.
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