Endo Pharmaceuticals and Bioniche Life Sciences Inc. announced enrollment of the first patient in the second phase III clinical trial of Urocidin. The trial is a randomized, active-controlled, open-label, multi-centre study with a blinded endpoint assessment designed to compare Urocidin with mitomycin C in the intravesical treatment of patients with BCG recurrent or refractory non-muscle-invasive bladder cancer.
It is estimated that 450 patients will be enrolled for this new trial at approximately 120 clinical sites worldwide. Summary details of the study protocol are now publicly available via the US National Institutes of Health (NIH) clinical trial registration service at http://www.clinicaltrials.gov/.
In North America, bladder cancer is the fourth most common cancer in men and the fifth overall between both men and women. 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 per cent of bladder cancer patients have the non-muscle-invasive form of bladder cancer. Collectively across the US, Europe and Japan, approximately 350,000 non-muscle-invasive bladder cancer patients are newly diagnosed or have a recurrence each year.
Non-muscle-invasive 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 is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.
Urocidin is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. Urocidin is formulated for the treatment of 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. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a C$9.6 million loan to be repaid by Bioniche from sales.
Endo holds exclusive global rights to develop and market Bioniche's patented formulation of Mycobacterial Cell Wall-DNA Complex (MCC), Urocidin(TM), being developed for the intravesical treatment of non-muscle-invasive bladder cancer.Under the licensing agreement, Bioniche received an up-front payment of US$20 million in July 2009, and became eligible to receive an additional US$110 million in milestone payments. Milestones are announced as they are achieved and, with its exclusive manufacturing supply contract, Bioniche provides clinical trial material and will also receive a net-sales-based revenue stream upon product approval.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs over 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety.
Endo Pharmaceuticals is a US-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics and aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology.