Bioniche Life Sciences Inc. to Publish Comprehensive Phase 3 Clinical Trial Results In The Journal of Urology

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.

Except for historical information, this news release may contain "forward-looking statements" and "forward-looking information" within the meaning of applicable securities laws that reflect the Company's current expectation regarding future events, including, without limitation, the proposed use of proceeds and the timing and completion of the Offering. Forward-looking statements and information are necessarily based upon a number of estimates and assumptions that, while, considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Readers are cautioned that any such forward-looking statements and information are not guarantees and there can be no assurance that such statements and information will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements and information. These forward-looking statements and information 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. The Company expressly disclaims any intention or obligation to update or revise any forward-looking statements and information whether as a result of new information, future events or otherwise. All written and oral forward-looking statements and information attributable to us or persons acting on our behalf are expressly qualified in their entirety by the foregoing cautionary statements.

SOURCE: Bioniche Life Sciences Inc.

Donald Olds, Chief Operating Officer
Bioniche Life Sciences Inc.
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