Bioniche Life Sciences Inc. announced that an agreement has been reached with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure. This SPA agreement relates to the Company's pivotal Phase III study using its proprietary Mycobacterial Cell Wall-DNA Complex (MCC) in non muscle-invasive bladder cancer at high risk of recurrence or progression.
Bioniche plans to begin recruitment of patients for the second pivotal study in Q1, calendar 2008. The study will enrol approximately 800 patients in North America, Australia and Europe and is a double-blind, randomized study. It will compare MCC to the standard treatment for non muscle-invasive bladder cancer at high risk of recurrence or progression - Bacillus Calmette-Guérin (BCG). BCG is a live, attenuated strain of Mycobacterium bovis and is often associated with treatment-limiting side effects including active bacterial infections.
The primary efficacy endpoint will be the duration of disease-free survival of patients after two years. In addition, safety will be evaluated based on two criteria: the percentage of patients who experience two consecutive delays of one week in treatment administration due to drug-related adverse events; and through a comparative tabulation of drug-related adverse events. The goal will be to demonstrate non-inferior efficacy and improved safety of Urocidin over BCG.
The Company continues to enrol patients in its first Phase III clinical trial, an open-label study showing the efficacy of MCC as therapy in superficial bladder cancer refractory (unresponsive) to BCG. This first pivotal trial was granted fast-track status by the FDA in May, 2006. The target enrolment of this study is 105 patients and the Bioniche clinical team expects the trial to be fully enrolled towards the end of calendar 2007. The trial's Data Safety Monitoring Committee held its first meeting in mid-August, at which time it reviewed the data generated to date and recommended that the trial continue unmodified.