Navigation Links
Bioniche Phase III Clinical Trial with Urocidin(TM) Given Continued Green Light by DMC
Date:8/24/2009

BELLEVILLE, ON, Aug. 24 /PRNewswire-FirstCall/ - 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. Recruitment has been completed in its 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-Guerin (BCG).

The Data Monitoring Committee (DMC) held its ninth meeting regarding this clinical trial last 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 scheduled to occur in October.

The DMC 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 DMC 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 program.

Second Phase III Registration Trial

Bioniche is working with its new licensing partner, Endo Pharmaceuticals Inc., on setting up clinical trial sites for 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.

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 percent of 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 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 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.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Bioniche Repays Revolving Credit Facility
2. Bioniche Provides a Corporate Update
3. Bioniche Pharma and Synerx Pharma Launch Melphalan Hydrochloride for Injection
4. Bioniche Represented at House of Commons Sub-Committee on Food Safety
5. Bioniche Phase III Clinical Trial with Urocidin(TM) Progressing Well
6. Bioniche Reports Fiscal 2009 Third Quarter
7. Bioniche Provides a Corporate Update
8. Bioniche Completes Recruitment in First Phase III Clinical Trial with Urocidin(TM)
9. Bioniche Revolving Credit Facility Maturity Date Amended
10. Bioniche Phase II Bladder Cancer Trial Results Published in The Journal of Urology
11. Bioniche Warrants Expiration Date to be Extended
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... ... April 29, 2016 , ... ... Footwear Foundation, the national charitable foundation serving the footwear industry, has broken all ... representing more than 130 companies across 23 states during the months of April ...
(Date:4/29/2016)... ... April 29, 2016 , ... Our bodies are bombarded daily by ... and deal with these stressors is to adopt a more healthful diet, but too ... Risa Groux, a certified Holistic Nutritionist and the creator of the Newport Beach Cleanse ...
(Date:4/29/2016)... ... April 29, 2016 , ... Dr. Bernie ... best seller "LOVE, MEDICINE and MIRACLES") addresses touchy topics related to Death live ... thereafter . Dr. Bernie Siegel, author of a plethora of essential books-to-read ...
(Date:4/29/2016)... ... ... Coast Dental Fort Stewart is celebrating its grand opening with an open ... Mall at 112 Vilseck Road in Fort Stewart. There will be refreshments, giveaways, and ... the opportunity to meet general dentists Thomas Richards, DDS, and Josh Faulk, DMD, and ...
(Date:4/29/2016)... ... April 29, 2016 , ... The Wharton ... $30,000 Perlman Grand Prize of the 2016 Wharton Business Plan Competition —as ... People’s Choice Award, and the Committee Award for Most ‘Wow Factor,’ making them ...
Breaking Medicine News(10 mins):
(Date:4/29/2016)... April 29, 2016 ... Financier Sanofi, leader mondial ... ses résultats pour le premier trimestre ... Jérôme Contamine, commente les résultats du ... perspectives pour le reste de l,année. ...
(Date:4/29/2016)... April 29, 2016 Automation is ... laboratory due to the growing demands for productivity in ... contemporary automated systems are already adept of a wide ... tedious and manual labor. Instrumentation continues to evolve, and ... conceivable just a few years ago. Originally used mostly ...
(Date:4/28/2016)...  While Abbott,s announced purchase of St. Jude ... and stent business, healthcare research firm Kalorama Information ... into patient monitoring.  Kalorama said that patient monitoring ... with double-digit growth expected the next 5 years, ... Patient Monitoring . Abbott Laboratories agreed to ...
Breaking Medicine Technology: