Bioniche Therapeutics Corp.
Bioniche Therapeutics Corp. 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.
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.
Bioniche initiated its Phase III bladder cancer clinical program in November, 2006
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.
A second Phase III clinical trial of Urocidin™ was started in February, 2011. The trial was to be a randomized, active-controlled, open-label, multi-centre 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. This trial was discontinued in November, 2012.
Bioniche One Health
Beyond its Canadian licensed cattle vaccine against E. coli O157, trademarked Econiche, Bioniche one Health 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.