Bioniche Life Sciences Inc. ("Bioniche"; TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today provided an update on its Phase III clinical program evaluating Urocidin(TM) in the treatment of bladder cancer. Recruitment has been completed in its Phase III registration trial evaluating Urocidin in the treatment of non-muscle-invasive bladder cancer that is refractory (unresponsive) to the current standard immunotherapy - Bacillus Calmette-Guérin (BCG).
The Data Monitoring Committee (DMC) held its ninth meeting regarding this clinical trial last week. After its meeting, the Committee has recommended that Bioniche "continue the trial unmodified until the next scheduled or triggered meeting." The next scheduled meeting of the Committee is scheduled to occur in October.
The DMC is an independent group that acts in an advisory capacity to the Company. Its role is to evaluate the progress of the clinical trial, including monitoring the safety and efficacy data generated in the trial. On a regular basis, the DMC reviews study results, evaluates the incidence of adverse events, determines whether the basic trial assumptions remain valid, and evaluates whether the overall integrity, scientific merit and conduct of the study remain acceptable.
Data from the full cohort of 105 high-grade bladder cancer patients from this trial, coupled with additional safety information to be collected from a second clinical trial that is expected to start later this year, will be used to support regulatory submissions under the FDA's Accelerated Approval program.
Second Phase III Registration Trial