BELLEVILLE, ON, March 31 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. , a research-based, technology-driven Canadian biopharmaceutical company, today announced that it has completed recruitment in its initial Phase III registration trial evaluating Urocidin(TM) in the treatment of non-muscle-invasive bladder cancer that is refractory (unresponsive) to the current standard immunotherapy - Bacillus Calmette-Guerin (BCG).
In this U.S. Food and Drug Administration (FDA)-approved and Fast Track designated trial, 105 evaluable patients with non-muscle-invasive bladder cancer received Urocidin in an open label trial. Thirty-one urology centres in North America participated, with Dr. Alvaro Morales, Director of the Centre for Advanced Urological Research and Professor in the Department of Urology, Queen’s University, Kingston, Ontario, Canada as Global Principal Investigator.
“We are pleased to have achieved this milestone with the enthusiastic support of the clinical investigators,” said Dr. Francois Charette, Chief Medical Officer at Bioniche Life Sciences Inc. “We look forward to having efficacy and safety data available to share with urologists.”
Data from the full cohort of evaluable patients from this trial, coupled with additional safety information to be collected from a second clinical trial that will start later this year, will be used to support regulatory submissions under the FDA’s Accelerated Approval program.
Bioniche plans to conduct a second registration trial that will directly compare the efficacy and safety of Urocidin with BCG in the first-line treatment of non-muscle-invasive bladder cancer. In September, 2007, the Company announced that an agreement had been reached with the FDA under the Special Protocol Assessment (SPA) procedure on the design of the trial, including its endpoints, data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a Biologics Licensing Application (BLA). An SPA gives a clear pathway to registration of Urocidin when the trial endpoints are achieved. This indication for MCC received Fast Track designation by the FDA last year. The Company expects to start this trial at such time as it has a marketing partner in place.
About Bladder Cancer
In North America, bladder cancer is the fourth most common cancer in men and in the top ten for women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year. In addition, the cancers of many previously-diagnosed patients remain unresolved, sometimes leading to cystectomy (bladder removal) or death. Approximately 70% bladder cancer patients have the non-muscle-invasive form of bladder cancer at diagnosis and, on appropriate regulatory approvals, might be eligible for multiple treatments with Urocidin.
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.
About Urocidin(TM)
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, coming into contact with immune system cells and bladder cancer cells. Industry Canada’s Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of the Company’s mycobacterial cell wall technologies by means of a C$9.6 million loan that is recoupable 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 products for human and animal health markets worldwide. The fully-integrated company employs approximately 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company’s primary goal is to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health. Bioniche has been named one of the Top 50 Best Small and Medium-Sized Employers in Canada for 2009. 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.
CONTACT: Jennifer Shea, Vice-President, Communications, Investor &
Government Relations, Bioniche Life Sciences Inc., Telephone: (613)
966-8058, Cell: (613) 391-2097, Jennifer.Shea@Bioniche.com
