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FDA Approves IND Application for Mycobacterial Cell Wall-DNA Complex, Treatment for Bladder Cancer
Approximately 142,000 patients in North America and Europe are newly- diagnosed with high-risk superficial bladder cancer each year. Approximately 96,000 of these are high-risk cases, of which 30%+/- are refractory to standard therapy.
In this first part of the Phase III program, 105 patients will be involved in an open-label study showing the efficacy of MCC as therapy in superficial bladder cancer refractory (unresponsive) to Bacillus Calmette-Guerin (BCG). BCG is a live, attenuated strain of Mycobacterium bovis, the current standard therapy for bladder cancer, but one that is often associated with treatment-limiting side effects. This Bioniche study will be conducted in North America. Patient enrolment will commence in the second quarter of calendar 2006. This clinical trial is expected to take between three and four years to complete.
The FDA is currently reviewing the IND for the second part of the Company's Phase III program, in which approximately 600 patients will be involved in a randomized, double-blind, multi-centre study comparing MCC to BCG as first-line therapy in superficial bladder cancer at high risk of recurrence or progression. This study will take place in both North America and Europe. "We are optimistic that we will receive the go-ahead on this second part of our Phase III program shortly," said Dr. Francois Charette, Chief Medical Officer at Bioniche Life Sciences Inc. "In approving part one, the FDA has responded positively to our data package, including results of previous human and laboratory animal studies; the mode of action of MCC against bladder cancer; its safety profile: the schedule of treatment; and how it is manufactured."
"This is a significant event in the history of Bioniche Life Sciences Inc.," stated Graeme McRae, President & CEO. "We have been working with our proprietary mycobacterial cell wall technology since 1997, with the intent to develop it as a treatment for human cancers. Bladder cancer, our first indication, is a debilitating disease, affecting more than 140,000 people annually in North America and Europe."
Mycobacterial Cell Wall-DNA Complex (MCC) is formulated from Mycobacterium phlei, a non-pathogenic strain of mycobacteria. MCC has been shown to have immune stimulatory and apoptosis (programmed cell death) activity against cancer cells. The product is a sterile biological composition in a sub-micron suspension. The product is produced at the Bioniche manufacturing facility in Pointe-Claire, Quebec.
"We have conducted numerous studies with MCC over the past nine years," added Dr. Nigel Phillips, Chief Scientific Officer at Bioniche Life Sciences Inc. "MCC's anticancer activity appears to be independent of cell mutational status and does not appear to select for resistance in cancer cell lines. In addition, it has been shown to be effective against multi-drug resistant bladder cancer cells. It is a very impressive technology."
Phase II clinical studies were conducted with MCC as a treatment for bladder cancer. In one study, 55 patients were enrolled. All had been suffering from carcinoma in situ (CIS), one of the most aggressive forms of superficial bladder cancer. Their cancer was not responding to the standard treatments of superficial bladder cancer (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 as demonstrated by cystoscopy, biopsy, and cytology ranged was dose-related, with the 8 mg dose obtaining a response rate of approximately 50% in previously BCG treated patients. The safety profile in the study was superior to standard therapy.
Dr. Alvaro Morales, Professor of Urology and Oncology at Queen's University in Kingston, Ontario was the Principal Investigator in the Phase I/II study, and will be the International Principal Investigator for the Phase III program.
"I am pleased to be joined by approximately 70 urologists internationally in the execution of the Phase III program," said Dr. Morales. "I am particularly pleased that Dr. Harry Herr, from Memorial Sloan Kettering Cancer Center in New York has agreed to be the North American Principal Investigator and Dr. Laurent Boccon-Gibod, from Hopital Bichat in Paris has agreed to be the European Principal Investigator. Their expertise in the treatment of bladder cancer will ensure a successful clinical study."
Source: Bioniche Life Sciences Inc.