Bioniche



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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Understanding Clinical Trials | Glossary of Key Terms

Urocidin^TM – a formulation of MCC - is currently being tested in a Phase III clinical program in bladder cancer. The first trial was initiated in November, 2006, for patients with non muscle-invasive bladder cancer that is refractory (unresponsive) to the current standard therapy – BCG. The Urocidin^TM clinical program is now being funded by and led by Endo Pharmaceuticals Inc. in partnership with Bioniche Life Sciences Inc.

Refractory trial

For more information about the Company’s clinical programs, please contact Bioniche Therapeutics at clinicaltrials@bioniche.com.

About Bladder Cancer,
from our Global Principal Investigator for the Phase III Clinical Program, Dr. Alvaro Morales

MCC and Carcinoma in situ of the Bladder

The final results of a Phase I/II clinical trial using Mycobacterial Cell Wall-DNA Complex (MCC) to treat superficial bladder cancer (SBC) were most recently presented at the the 2004 American Urological Association's 99th Annual Meeting in San Francisco in May, 2004.

In the Phase I/II trial, 55 patients were enrolled. All had been suffering for several years from carcinoma in situ (CIS), one of the most aggressive forms of SBC; their CIS was refractory to the traditional treatments of SBC (BCG and/or chemotherapy). During the study, the patients received one of two doses of MCC - either 4 mg or 8 mg - with evaluation at 3, 6, 12, and 18 months. The complete response at 12 months ranged (depending on the dose) from 43% to 64% of patients having no evidence of disease as demonstrated by cystoscopy, biopsy, and cytology. Only three of the patients in the study had to stop treatment with MCC, which is a much lower proportion than what is normally seen with those receiving BCG treatment, the traditional treatment for CIS.