FDA approves Bioniche's phase 3 bladder cancer trials

By Lisa Kerner

Erie, Pa., April 3 - Bioniche Life Sciences Inc. said the Food and Drug Administration has granted approval for the company's second of two phase 3 clinical trials using Bioniche's proprietary Mycobacterial Cell Wall-DNA Complex (MCC) (Urocidin) for the treatment of bladder cancer.

The second randomized, double-blind multi-center phase 3 trial of about 30 patients will compare Urocidin to Bacillus Calmette-Guerin (BCG) as first-line therapy in non-muscle invasive (superficial) bladder cancer at high risk of recurrence or progression.

While BCG is a live, attenuated strain of Mycobacterium bovis that is the current standard therapy for bladder cancer, it is associated with treatment-limiting side effects, according to a company news release.

The first phase 3 trial will involve 105 patients in an open-label study showing the efficacy of Urocidin as therapy in non-muscle invasive bladder cancer that is refractory (unresponsive) to BCG.

Bioniche said patient enrollment for both trials is expected to begin by mid-2006.

"We expect a 40% minimum complete response rate in the refractory study," president and chief executive officer Graeme McRae said in the release.

"Complete response means no evidence of disease after cystoscopy, cytology, and biopsy. The compelling results in our phase 1/2 studies in this patient population give us assurance that we will achieve this level of response. In the comparative study, we expect to show non-inferiority to BCG, which currently demonstrates a 60% to 70% response rate. In addition, we expect to show improved safety over BCG."

About 142,000 patients in North America and Europe are newly diagnosed with non-muscle invasive bladder cancer each year.

Bioniche is a research-based biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products. The company is located in Belleview, Ont.

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