Bioniche Life Sciences Inc. Discontinues Current Phase 3 Clinical Trial With Urocidin
Published: Nov 05, 2012
The trial, a randomized, active-controlled, open-label, multi-center study with a blinded endpoint assessment designed to compare UrocidinTM with mitomycin C in the intravesical treatment of patients with BCG recurrent or refractory non-muscle-invasive bladder cancer, was being run by the Company's global licensing partner, Endo Pharmaceuticals (Endo), a subsidiary of Endo Health Solutions.
The trial has not been recruiting at the expected rate and, after recent discussions with the U.S. Food and Drug Administration (FDA) regarding the current clinical trial design, Endo has decided to end the study before its scheduled completion. Endo and Bioniche are jointly considering potential next steps for the program.
"We are disappointed with this outcome, but we believe it is the best decision given the circumstances," said Mr. Graeme McRae, President & CEO of Bioniche Life Sciences Inc. "We are working with Endo to determine the next steps for the Urocidin clinical program in order to build on the successful outcome of the first Phase III trial and to continue to work toward regulatory approval for this important and much-needed therapy."
About Bladder Cancer
Bladder cancer is one of the leading causes of death among men and women and an estimated 357,000 bladder cancer cases occur worldwide each year. It is estimated that 73,510 new cases of bladder cancer and 14,880 deaths from bladder cancer will occur in the United States in 2012. In Canada, an estimated 7,800 (5,800 men; 2,000 women) new bladder cancer cases are expected in 2012. Bladder cancer is the 4th most common cancer in men and the 12th most common cancer in women in North America. The prevalence of non-muscle-invasive bladder cancer is ten times its incidence and creates a major economic burden on healthcare systems. As measured on the basis of cumulative per patient cost from the time of diagnosis until death, bladder cancer is the most expensive cancer to treat.
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. UrocidinTMis 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.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary and innovative products for human and animal health markets worldwide. The fully-integrated company employs more than 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company's primary goal is to develop and commercialize products that advance human or animal health and increase shareholder value.
For more information, please visit www.Bioniche.com.
Except for historical information, this news release may contain forward-looking statements that reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
SOURCE Bioniche Life Sciences Inc.