Navigation Links
Bioniche Provides Update on Refractory Bladder Cancer Trial with Urocidin(TM)
Date:2/13/2008

- Data Safety Monitoring Committee holds third meeting -

BELLEVILLE, ON, Feb. 13 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, is pleased to provide an update on the progress of its North American clinical trial with Mycobacterial Cell Wall-DNA Complex (MCC) - trademarked Urocidin - in patients with non muscle-invasive bladder cancer that is refractory to the current standard therapy. This indication was given Fast Track designation by the U.S. Food and Drug Administration (FDA) in April of 2006.

The Company commenced this trial in November, 2006. An investigators' meeting was held in April, 2007, and the trial has been progressing steadily since that time.

On February 7, 2008, the Data Safety Monitoring Committee held its third meeting regarding this clinical trial. The role of this independent body is to confirm that the safety of enrolled patients is being appropriately addressed and that, from an efficacy point of view, there is an appropriate basis for continuing the trial. After its meeting, the Committee has recommended that Bioniche "continue the trial unmodified until the next scheduled or triggered meeting." The next meeting of the Committee will be held in three months.

Patients are being enrolled in the trial's 25 sites on a regular basis. The targeted enrollment of this study is 105 patients which, coupled with additional safety information collected from a comparative trial, will allow full results to be reported one year after recruitment is completed for the efficacy and safety datasets. These results may also support regulatory submissions under FDA's Accelerated Approval program.

Bioniche is planning to conduct a second registration study in bladder cancer; a trial which will directly compare the efficacy of Urocidin with the incumbent therapy for non muscle-invasive bladder cancer. In September, 2007, the Company announced that an agreement has been reached with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure. This indicates agreement by the FDA on the design of the study, 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). A SPA gives a clear pathway to registration of Urocidin when the study endpoints are achieved.

Bioniche plans to begin recruitment of patients for the second pivotal study later this year. The study will enrol approximately 800 patients in North America, Australia and Europe and is a double-blind, randomized study. It will compare MCC to the standard treatment for non muscle-invasive bladder cancer at high risk of recurrence or progression - Bacillus Calmette-Guerin (BCG). BCG is a live, attenuated strain of Mycobacterium bovis and is often associated with treatment-limiting side effects including active bacterial infections.

Bioniche also continues to have discussions with potential development and marketing partners, and the Company is well positioned and committed to execute a strategic partnership transaction related to the financing of Urocidin at the earliest opportunity.

About MCC

MCC is a sterile mycobacterial cell wall composition that has a dual mode of action: immune stimulation and direct anticancer activity. It is formulated as Urocidin(TM) for the treatment of bladder cancer, where it is administered by the intravesical route directly into the bladder, coming into contact with immune system cells and bladder cancer cells. MCC is also undergoing preclinical evaluation as a treatment for peritoneal carcinomatosis associated with colon and ovarian cancer.

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 Canada's Top Ten Life Sciences Companies for 2008. For more information, please visit http://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©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Bioniche Responds to Australian Equine Influenza Outbreak
2. Bioniche Receives $2 Million Government Grant For Market Development Related to its E. coli O157:H7 Cattle Vaccine
3. Bioniche Food Safety Vaccine Receives Global Top Honours in Industry Excellence Awards
4. Bioniche Receives Comment from USDA on a Field Trial for E. coli O157:H7 Cattle Vaccine
5. Media Advisory - Bioniche Discusses USDA Comment on E. coli O157:H7 Cattle Vaccine Field Trial
6. Bioniche to Present at Rodman & Renshaw 9th Annual Healthcare Conference
7. Bioniche Reports Fiscal 2008 First Quarter
8. Bioniche Receives $5 Million of Federal Government Support to Scale-up Vaccine Production in Ontario
9. Bioniche Amends Terms of Convertible Debt with Laurus Master Funds
10. USDA Agrees to Grant Conditional License to Bioniche for its E. coli O157:H7 Cattle Vaccine
11. Bioniche Reports Fiscal 2008 Second Quarter
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... 25, 2016 , ... First Choice Emergency Room , the largest network ... the Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased ... location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Conventional wisdom preaches ... success. In terms of the latter, setting the bar too high can result in ... than just slow progress toward their goal. , Research from PsychTests.com ...
(Date:6/24/2016)... ... 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out of ... verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... San Diego, CA (PRWEB) , ... June 24, 2016 , ... ... up with the American Cancer Society and the Road To Recovery® program to drive ... care to seniors and other adults to ensure the highest quality of life and ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... proud to recognize Dr. Barry M. Weintraub as a prominent plastic surgeon and ... women in the world, and the most handsome men, look naturally attractive. Plastic ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, Inc. ... will take whatever measures required to build a strong ... which is currently listed on the OTC Markets-pink current ... Chairman and CEO, "We are seeing an anomaly in ... understand, not only by the Company, but shareholders and ...
(Date:6/24/2016)... Calif. , June 24, 2016  Global ... a biopharmaceutical company developing novel therapeutics for the ... needs, today announced the closing of its previously ... common stock, at the public offering price of ... the offering were offered by GBT. GBT estimates ...
(Date:6/24/2016)... , June 24, 2016 The Academy of ... recommendations that would allow biopharmaceutical companies to ... entities that make formulary and coverage decisions, a move ... of new medicines. The recommendations address restrictions ... appear on the drug label, a prohibition that hinders ...
Breaking Medicine Technology: