Bioniche Phase II Bladder Cancer Trial Results Published in The Journal of Urology



    
    - results from this trial supported entry into Company's current Phase
    III bladder cancer program -
    

    BELLEVILLE, ON, Feb. 18 /CNW/ - Bioniche Life Sciences Inc. (TSX: BNC), a
research-based, technology-driven Canadian biopharmaceutical company, today
announced that The Journal of Urology has published an article summarizing the
Phase II clinical trial results for the Company's proprietary Mycobacterial
Cell Wall technology in bladder cancer.
    The article, entitled "Intravesical Mycobacterial Cell Wall-DNA Complex
in the Treatment of Carcinoma In Situ of the Bladder After Standard
Intravesical Therapy has Failed", was co-authored by Drs. Alvaro Morales
(Queen's University - Kingston, Ontario, Canada), Kiran Phadke (St.-George
Hospital, Kogarah, New South Wales, Australia), and Gary Steinhoff (Vancouver
Island Health Authority - Victoria, British Columbia, Canada). The Phase II
trial resulted in a complete response rate in the intent-to-treat population
of 27.3% at weeks 12 and 26 at a 4 mg dose and a 46.4% response at the same
two points in patients receiving an 8 mg dose. Complete response was defined
as no evidence of disease as determined by cystoscopy, biopsy and cytology.
The product was well tolerated by both dose groups, with 90% of all adverse
events being mild to moderate in severity.
    "We concluded that Mycobacterial Cell Wall-DNA Complex has shown
antineoplastic (anticancer) activity in patients with bladder cancer with less
toxicity than that associated with bacillus Calmette-Guerin (BCG)
administration," said Dr. Alvaro Morales, Director of the Centre for Advanced
Urological Research and Professor in the Department of Urology, Queen's
University, Kingston, Ontario, Canada. "Safety concerns exist with BCG because
it is a live mycobacterium and its use is associated with a number of local
and systemic side effects, as well as the potential for proliferation and
systemic dissemination."
    The article depicts Phase II exploratory work that has supported the
entry of MCC into a Phase III clinical program that has been reviewed and
approved by the U.S. Food and Drug Administration (FDA). The first of two
Phase III FDA-approved registration trials is nearing enrolment completion. In
this trial, patients with non-muscle-invasive bladder cancer whose cancer is
specifically refractory (unresponsive) to BCG are receiving a formulation of
Mycobacterial Cell Wall-DNA Complex, trademarked Urocidin, in an open label
trial. Thirty-one urology centres in North America are participating in this
trial and recruitment of 105 evaluable patients is expected to be completed by
the end of March, 2009.
    Data from the full cohort of evaluable patients, coupled with additional
safety information to be collected from a comparative trial, will allow
efficacy results to be reported one year after recruitment is completed. These
results, coupled with additional safety data, may be used to support
regulatory submissions under the 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 initiated in June, 2008.

    Data Safety Monitoring Committee

    The Data Safety Monitoring Committee held its seventh scheduled meeting
regarding this clinical trial last week. 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.

    Second Phase III Registration Trial

    Bioniche plans 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. 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 trial received
Fast Track designation by the FDA last year. The Company expects to start this
trial at such time as it has a marketing partner in place.

    About MCC

    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 The Journal of Urology

    Established in 1917, The Journal of Urology (www.jurology.com) is the
official journal of the American Urological Association (www.auanet.org). It
is the most widely read and highly cited journal in the field. It brings to
its readership all the clinically relevant information needed to stay at the
forefront of this dynamic field. This top-ranking journal presents
investigative studies on critical areas of research and practice, survey
articles providing short condensations of the best and most important urology
literature worldwide and practice-oriented reports on interesting clinical
observations.

    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 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.

    %SEDAR: 00013159EF




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

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