- Data Safety Monitoring Committee holds third meeting -
BELLEVILLE, ON, Feb. 13 /CNW/ - 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-Guérin
(BCG). BCG is a live, attenuated strain of Mycobacterium bovis and is often
associated with treatment-limiting side effects including active bacterial
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.
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 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.
For further information:
For further information: Jennifer Shea, Corporate Communications,
Investor & Government Relations Director, Bioniche Life Sciences Inc.,
Telephone: (613) 966-8058, Cell: (613) 391-2097, Jennifer.Shea@Bioniche.com