BELLEVILLE, ON, May 22 /CNW/ - Bioniche Life Sciences Inc. ("Bioniche";
TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical
company, today provided an update on its Phase III clinical program evaluating
Urocidin(TM) in the treatment of bladder cancer. On March 31st, the Company
announced that recruitment had been completed in its initial Phase III
registration trial evaluating Urocidin in the treatment of non-muscle-invasive
bladder cancer that is refractory (unresponsive) to the current standard
immunotherapy - Bacillus Calmette-Guérin (BCG).
The Data Safety Monitoring Committee (DSMC) held its eighth meeting
regarding this clinical trial earlier this week. After its meeting, the
Committee has recommended that Bioniche "continue the trial unmodified until
the next scheduled or triggered meeting." The next scheduled meeting of the
Committee is July.
The DSMC is an independent group that acts in an advisory capacity to the
Company. Its role is to evaluate the progress of the clinical trial, including
monitoring the safety and efficacy data generated in the trial. On a regular
basis, the DSMC reviews study results, evaluates the incidence of adverse
events, determines whether the basic trial assumptions remain valid, and
evaluates whether the overall integrity, scientific merit and conduct of the
study remain acceptable.
Data from the full cohort of 105 high-grade bladder cancer patients from
this trial, coupled with additional safety information to be collected from a
second clinical trial that is expected to start later this year, will be used
to support regulatory submissions under the FDA's Accelerated Approval
Second Phase III Registration Trial
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 development
and 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.
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 has been 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
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.
For further information:
For further information: Jennifer Shea, Vice-President, Communications,
Investor & Government Relations, Bioniche Life Sciences Inc., Telephone: (613)
966-8058, Cell: (613) 391-2097, Jennifer.Shea@Bioniche.com