Bioniche Life Science (BNHLF)

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Google translate on today's PR

Bioniche Life Sciences Inc. will release the full results of a clinical phase III study in The Journal of Urology

MONTREAL, Oct. 10, 2014 / CNW / -. Bioniche Life Sciences Inc. (TSX, BNC, KFN and BNHLF the TSX) today announced that The Journal of Urology has agreed to publish a manuscript document Efficacy and Safety in Patients with MCNA of Non-Muscle Invasive Bladder Cancer at High Risk of Recurrence-and progression Who Have Failed Treatment with Bacillus Calmette-Guerin. A full version of the article is now available online for review and citation at www.jurology.com (http://www.jurology.com/article/S0022-5347(14)04590-X/abstract) ; the printed version is tentatively scheduled for April 2015.

The data presented in this article refer to a study of phase III conducted on a complex cellular nucleic acid-wall mycobacterial (Mycobacterium phlei MCNA or cell wall-nucleic acid complex) and include the results of statistical analyzes required the end of the study, including the efficacy rate three months, six months and two years after treatment. Post-hoc analyzes were conducted to determine the effectiveness of MCNA in subgroups of patients in whom treatment with bacillus Calmette-Guerin (BCG) has failed, and treatment outcomes such as duration of response, the effect on disease progression and rates of cystectomy, are also presented. These analyzes complement the previous preliminary results of the study were presented in abstract form at the time of the Congress of Urology held in North America and internationally.

Commenting on the article, Dr. Michael Berendt, CEO and Chief Scientific Officer of Bioniche, said: "We are very pleased to present, for the first time, the world community urologists, a set of comprehensive data on our study of phase III which will underpin our license application for a biological product. We continue to believe that our flagship product, MCNA, meets a real unmet medical need in this population at high risk, underserved, that is refractory to current standard of care, treatment with BCG, and research treatments not surgery to avoid or delay cystectomy. "

The corresponding author of the paper and the principal investigator of the study based Phase III MCNA, Dr. Ashish M. Kamat, professor and surgeon holds the Urology Department / Division of Surgery and Director of postgraduate urologic oncology at MD Anderson Cancer Center at the University of Texas program, said: "The intravesical treatment with MCNA offers an alternative for patients in whom treatment with BCG has failed and who not want to undergo radical cystectomy. Since its mode of action is based on a combination of direct cytotoxic and immunological principles, the MCNA also has the potential to provide a sustainable response. "