Recap..Urocidin may provide an alternative to cystectomy https://www.specialtypharmajournal.com/index.php?option=com_content&view=article&id=2669:urocidintm-may-hold-promise-as-bladder-cancer-treatment&catid=344:oncology&Itemid=556 The intravesical formulation of mycobacterial cell wall-DNA complex (MCC), known as Urocidin(TM), may provide an alternative to cystectomy for patients with bacillus Calmette-Guerin (BCG) refractory non-muscle invasive bladder cancer (NMIBC). That's according to preliminary Phase III trial results presented at the 2011 American Urological Association annual meeting in Washington, D.C. by Endo Pharmaceuticals and Bioniche Life Sciences. The preliminary results were generated from an interim analysis in an ongoing Phase III trial with Urocidin(TM) 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(TM) was well tolerated. Ongoing Phase III Clinical Program with Urocidin(TM) Summary details of a Phase III clinical trial protocol with Urocidin(TM) being conducted by Endo are publicly available via the U.S. National Institutes of Health (NIH) clinical trial registration service at https://www.clinicaltrials.gov. This trial is actively enrolling eligible NMIBC patients. Bladder cancer is the fourth most common cancer in men and the fifth overall between both men and women in North America. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year and 500,000 living patients have been affected. In Europe, more than 100,000 patients are newly diagnosed each year. Bladder cancer is frequently a recurrent disease, with some cases becoming refractory to available chemotherapeutic or immunotherapeutic agents and leading to cystectomy (bladder removal) or death. Approximately 70 percent of bladder cancer patients have the non-muscleinvasive form of bladder cancer. Collectively across the U.S., Europe and Japan, approximately 350,000 non-muscleinvasive bladder cancer patients are newly diagnosed or have a recurrence each year. Non-muscleinvasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin(TM) is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder. Urocidin(TM) is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that appears to have a dual mode of action: immune stimulation and direct anticancer activity. Urocidin(TM) is being investigated for the treatment of non-muscle invasive bladder cancer, where it is administered by trans-urethral catheter directly into the bladder. The agent is then able to directly interact with the cells of the immune system and bladder cancer cells.