May 9, 2012
Bioniche Life Sciences Inc. Reports Q3, Fiscal 2012 Results

May 1, 2012
Bioniche Life Sciences Inc. Commercializing Two Products for Canine Cancer

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Bioniche Therapeutics is responsible for scientific discovery, pre-clinical research, clinical studies, regulatory submissions, as well as the development and commercialization of human health products derived from proprietary technologies.

Therapeutic Focus

Discovery research at Bioniche focuses primarily on areas of medicine where there is a strong need for safer, more efficacious therapies: specifically in oncology and immunomodulation.

Pre-clinical research and formulation research is conducted in the company's facilities located within the Bioniche Therapeutics Research Centre at the NRC Biotechnology Research Institute in Montreal, Quebec.

Clinical Studies

Bioniche initiated its Phase III bladder cancer clinical program in November, 2006. The program is being funded and led by Endo Pharmaceuticals Inc. in partnership with Bioniche Life Sciences Inc.

The objective of the first Phase III trial is to evaluate the efficacy and safety of Urocidin™ in patients with non-muscle-invasive bladder cancer (NMIBC) who are refractory to intravesical Bacillus Calmette- Guérin (BCG) therapy and at high risk of progression. A total of 129 patients were enrolled from 25 centers in the U.S. and Canada, with high grade papillary and/or carcinoma in situ (CIS) and having failed to respond to one or more courses of BCG. The overall one-year disease-free survival (DFS) rate was 25 percent. DFS is defined as lack of recurrence or progression to muscle-invasive disease, as confirmed by biopsy. In terms of safety, the results showed that intravesical administration of Urocidin™ was well tolerated, with most adverse events being mild to moderate in severity and few leading to discontinuation of treatment. The authors of an abstract presented at the European Association of Urology World Congress in March, 2011 (pdf/2011/MCC11032_3001_EAU_FINAL.PDF) concluded that the interim analysis of this prospective trial indicates that Urocidin™ may provide an alternative to cystectomy for patients with BCG-refractory NMIBC.

The first patient was enrolled in a second Phase III clinical trial of Urocidin™ in February, 2011. The trial is a randomized, active-controlled, open-label, multi-center study with a blinded endpoint assessment designed to compare Urocidin™ with mitomycin C in the intravesical treatment of patients with BCG recurrent or refractory non-muscle-invasive bladder cancer. It is estimated that 450 patients will be enrolled for this new trial at approximately 120 clinical sites worldwide. Summary details of the study protocol are now publicly available via the U.S. National Institutes of Health (NIH) clinical trial registration service at www.clinicaltrials.gov.

Beyond its Canadian licensed cattle vaccine against E. coli O157, trademarked Econiche, Bioniche Food Safety has a pipeline of vaccines in development. These include a recombinant E. coli O157 vaccine and a Salmonella vaccine. The Company is focused on addressing diseases harboured by animals that can cause human illness.