May 13, 2008
Bioniche Updates re: Mycobacterial Cell Wall Technology Platform

May 9, 2008
Bioniche Reports Fiscal 2008 Third Quarter

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Understanding Clinical Trials  |  Glossary of Key Terms

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.