Bioniche Life Sciences Inc. Announces Discontinuation of Current Phase III Clinical Trial with Urocidin™

Bioniche Life Sciences Inc. Announces Discontinuation of Current Phase III 
Clinical Trial with Urocidin™ 
-Bioniche and Endo discussing potential next steps for Urocidin™ clinical 
program-
BELLEVILLE, ON, Nov. 5, 2012 /CNW/ - 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 Urocidin(TM) 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 4(th) most common cancer in men and the 12(th) 
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 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(TM) 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. 
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. 
Jennifer Shea, Vice-President, Communications, Investor & Government  
Relations Bioniche Life Sciences Inc. Telephone: (613) 966-8058; from 
Australia: 0011 1 613-966-8058 Cell: (613) 391-2097; from Australia: 0011 1 
613-391-2097 Jennifer.Shea@Bioniche.com 
SOURCE: Bioniche Life Sciences Inc. 
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CO: Bioniche Life Sciences Inc.
ST: Ontario
NI: MTC  
-0- Nov/05/2012 12:00 GMT
 
 
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