Bioniche Life Sciences and partner Endo Pharmaceuticals claim interim data from an ongoing Phase III trial evaluating Urocidin™ in patients with bacillus Calmett-Guerin (BCG)-refractory nonmuscle invasive bladder cancer (NMIBC) suggest the treatment may represent an alternative to cystectomy.
The new trial results in 129 patients in the U.S. and Canada showed that for patients with high-grade papillary tumors and/or carcinoma in situ who failed to respond to one or more courses of BCG, treatment using Urocidin was associated with an overall one-year disease-free survival (DFS) rate of 25%. DFS was defined as a lack of recurrence or progression to muscle-invasive disease. The one-year DFS rate was 35% for patients with only papillary tumors, and 21% for those with carcinoma in situ, with or without papillary tumors.
A second, global Phase III study evaluating Urocidin was initiated in February. This open-label, active-controlled trial will compare Urocidin with mitomycin C in the intravesical treatment of about 450 patients with BCG-recurrent or BCG-refractory NMIBC.
Urocidin is a formulation of mycobacterial cell wall-DNA complex (MCC), which appears to have both immunostimulatory and direct anticancer activities, Bioniche claims. The treatment is administered by transurethral catheter directly into the bladder. Endo holds exclusive global rights to develop and market Urocidin for the intravesical treatment of nonmuscle invasive bladder cancer. Under terms of the deal, signed in 2009, Bioniche received a $20 million up-front payment and could earn another $110 million in milestones.