MONTREAL,
Oct. 10, 2014 /PRNewswire/ - Bioniche
Life Sciences Inc. (TSX: BNC: PNK:BNHLF) today announced that The
Journal of Urology has accepted for publication a manuscript
entitled: Efficacy and Safety of MCNA in Patients with
Non-Muscle Invasive Bladder Cancer at High-Risk of Recurrence and
Progression Who Have Failed Treatment with
Bacillus Calmette-Guérin. An unedited version of the
paper is now available for review and citation online at
www.jurology.com
(http://www.jurology.com/article/S0022-5347(14)04590-X/abstract);
with an expected in print date tentatively scheduled for
April 2015.
The data reported in this publication pertains to pivotal Phase
3 study conducted with MCNA (Mycobacterium phlei cell wall-nucleic
acid complex) and includes results of planned statistical analyses
at study completion including efficacy rates at 3 and 6 months and
2 years after therapy. Post-hoc analyses were performed to
determine the efficacy of MCNA in subgroups of
bacillus Calmette-Guérin (BCG)-failure patients and outcomes
of treatment such as duration of response, impact on progression
and cystectomy rates are also presented. These analyses complement
the previous interim study results that appeared in abstract form
which were presented at North American and international urology
conferences.
Commenting on this publication, Bioniche's CEO & Chief
Scientist, Dr. Michael Berendt
declared: "We are very excited to be able to report to the global
urology community, for the first time, a comprehensive dataset from
our pivotal Phase 3 study that will serve as the foundation of our
upcoming Biologics License Application (BLA) filing. We
continue to believe that our lead product, MCNA, addresses a real
unmet medical need in this poorly served, high-risk population who
have failed the current standard of care, BCG treatment, and who
seek non-surgical treatment alternatives to prevent or delay
cystectomy.
The article's corresponding author and a
Principal Investigator in the MCNA pivotal Phase 3 study, Dr.
Ashish M. Kamat, a Professor and
Attending Surgeon in the Department of Urology/Division of Surgery
and Director of the Urologic Oncology Fellowship Program at The
University of Texas MD Anderson Cancer Center commented:
"Intravesical MCNA offers an alternative for patients who have
failed therapy with BCG and do not wish to undergo a radical
cystectomy. Since it's mechanism of action is based on a
combination of immunologic and direct cytotoxic principles, it has
the potential to establish durable response as well."
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a late clinical
stage Canadian biopharmaceutical company focused on the
development, manufacturing, marketing and licensing/acquisition of
proprietary and innovative therapies for the global human health
market. The Company's primary goal is to develop and commercialize
products that advance human health and increase shareholder value.
For more information, please visit www.Bioniche.com.
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SOURCE Bioniche Life Sciences Inc.