Bioniche receives FDA OK for phase 3 studies of bladder cancer treatment

By Lisa Kerner

Erie, Pa., Feb. 8 - Bioniche Life Sciences Inc. said the Food and Drug Administration has approved its Investigational New Drug application for the first of two phase 3 clinical trials using the company's proprietary Mycobacterial Cell Wall-DNA Complex (MCC) for the treatment of bladder cancer.

The first part of the phase 3 program will be an open-label study of 105 patients showing the efficacy of MCC as therapy in superficial bladder cancer refractory (unresponsive) to Bacillus Calmette-Guerin (BCG), according to a company news release.

Patient enrollment is slated to begin in the second quarter of this year. Bioniche expects the clinical trial to take between three and four years to complete.

The second part of the phase 3 program, currently under review by the FDA, will be a randomized, double-blind, multi-center study of about 600 patients comparing MCC to BCG as first-line therapy in superficial bladder cancer at high risk of recurrence or progression.

"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," Graeme McRae, president and chief executive officer, said in the release.

"Bladder cancer, our first indication, is a debilitating disease, affecting more than 140,000 people annually in North America and Europe."

BCG is a live, attenuated strain of Mycobacterium bovis, the current standard therapy for bladder cancer often associated with treatment-limiting side effects, the company said.

MCC is formulated from a non-pathogenic strain of mycobacteria and has been shown to have immune stimulatory and apoptosis (programmed cell death) activity against cancer cells.

Phase 2 clinical studies of MCC as a treatment for bladder cancer in 55 patients with an aggressive form of the disease demonstrated that the 8 mg dose obtained a response rate of about 50% in previously BCG treated patients.

Bioniche is a research-based, technology-driven biopharmaceutical company based in Belleville, Ont.

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