- 5th Data Safety Monitoring Committee meeting held last week -
BELLEVILLE, ON, Aug. 18 /CNW/ - Bioniche Life Sciences Inc. (TSX: BNC), a
research-based, technology-driven Canadian biopharmaceutical company, today
announced that its first Phase III clinical trial with a formulation of
Mycobacterial Cell Wall-DNA Complex (MCC), trademarked Urocidin, for the
treatment of bladder cancer, is progressing well.
The Data Safety Monitoring Committee held its fifth scheduled meeting
regarding this clinical trial on August 14, 2008. 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 again
recommended that Bioniche "continue the trial unmodified until the next
scheduled or triggered meeting". The next scheduled meeting of the Committee
will be held in three months.
The protocol calls for 105 evaluable patients to be enrolled this trial.
These are patients with non-muscle-invasive bladder cancer that is refractory
(unresponsive) to bacillus Calmette-Guérin (BCG) therapy. BCG, the standard of
care for non-muscle-invasive bladder cancer, has limited efficacy, especially
as second-line therapy. It is associated with a number of treatment-limiting
side effects that include the potential for both local (bladder) and systemic
mycobacterial infections. The Company expects patient enrolment to be
completed by the end of calendar 2008.
Thirty-one investigational sites across North America are involved in
this clinical trial. Sites include: The Centre for Applied Urological Research
(Kingston, Ontario); Memorial Sloan-Kettering Cancer Center (New York, New
York); Johns Hopkins Brady Urological Institute (Baltimore, Maryland); M.D.
Anderson Cancer Center (Houston, Texas); and Sunnybrook Health Science Centre
The data collected from this 105-patient trial, when coupled with
additional safety information collected from a second clinical trial, will
allow full results to be reported approximately 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. 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 31st
site was validated in June, 2008.
Bioniche is planning to conduct a second registration trial which will
directly compare the efficacy and safety of MCC with BCG in the treatment of
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 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 MCC when the trial endpoints are
achieved. This study received Fast Track designation by the FDA in February of
Bioniche plans to begin recruitment of patients for the second pivotal
trial later this year. The trial will enrol approximately 800 patients and is
a double-blind, randomized trial.
MCC is a sterile mycobacterial cell wall-DNA complex 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 trans-urethral catheter directly into the bladder, coming into
contact with immune system cells and bladder cancer cells. MCC is 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, Vice-President, Communications,
Investor & Government Relations, Bioniche Life Sciences Inc., Telephone: (613)
966-8058, Cell: (613) 391-2097, Jennifer.Shea@Bioniche.com