MONTREAL, Oct. 10, 2014 /CNW/ - 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.
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Donald Olds, Chief Operating Officer
Bioniche Life Sciences Inc.
Telephone: (613) 966-8058