FDA approves Bioniche bladder cancer trial

The second phase III trial will involve approximately 630 patients in a randomized, double-blind multi-centre trial comparing Urocidin to bacillus calmette-guerin (BCG) as first-line therapy in non-muscle invasive (superficial) bladder cancer at high risk of recurrence or progression.

BCG is a live, attenuated strain of mycobacterium bovis that is the current standard therapy for bladder cancer, but is a treatment that is often associated with treatment-limiting side effects. The Bioniche study will be conducted in North America and Europe.

The first phase III trial will be carried out at the same time as the second. It 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. This study will be conducted in North America.

“We expect a 40% minimum complete response rate in the refractory study,” said Graeme McRae, president & CEO of Bioniche Life Sciences. “Complete response means no evidence of disease after cystoscopy, cytology, and biopsy. The compelling results in our phase I/II 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 – 70% response rate. In addition, we expect to show improved safety over BCG.”