Bioniche Life Sciences Inc. (BNC) Discontinues Current Phase 3 Clinical Trial With Urocidin™
11/5/2012 7:17:47 AM
BELLEVILLE, ON, Nov. 5, 2012 /PRNewswire/ -Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based,
technology-driven Canadian biopharmaceutical company, today announced
that a second Phase III clinical trial with Urocidin in non-muscle-invasive bladder cancer is being discontinued.
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.
About UrocidinTM 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.
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