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Bioniche Life (BNC:CA)
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Web site:
http://www.bioniche.com/
Bioniche has developed a technology for the treatment of human cancers. The first product developed from this technology is Urocidintm, a formulation of Mycobacterial Cell Wall-DNA Complex (MCC) for the treatment of bladder cancer. A Phase III clinical program is underway, in partnership with Endo Pharmaceuticals Inc.
For more information about the Company’s clinical programs, please contact Bioniche Therapeutics at clinicaltrials@bioniche.com
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 Urocidintm 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 Urocidintm 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 (http://www.bioniche.com/pdf/2011/MCC11032_3001_EAU_FINAL.PDF) concluded that the interim analysis of this prospective trial indicates that Urocidintm 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 Urocidintm in February, 2011. The trial is a randomized, active-controlled, open-label, multi-center study with a blinded endpoint assessment designed to compare UrocidinTM 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 http://www.clinicaltrials.gov.
Future plans to further develop UrocidinTM are being defined and will be disclosed by Endo.
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.
Bioniche Animal Health
Bioniche Animal Health was established in 1979 to develop vaccines and other pharmaceutical products for the preventive health management of animal diseases. Now the largest Canadian-owned animal health company, Bioniche Animal Health has a large product portfolio that can be categorized in three major groups: reproduction and embryo transfer, immunology and vaccine products. Folltropin®-V, the company's lead product, is the highest quality and best-selling follicle stimulating hormone (FSH) in the animal health marketplace worldwide. Folltropin®-V is used in the embryo transfer industry to induce superovulation in cattle and sheep. The company's research and development program has provided veterinarians and animal producers with a wide range of animal vaccines with proven safety profiles for use in cattle, swine, equine and companion animals.
Learn more about Bioniche Animal Health
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