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Phase III Clinical Program in Bladder Cancer
More than two-thirds of the 105 patients required for the Company's firstPhase III clinical trial with MCC (trademarked Urocidin) have now beenenrolled. The Company expects patient enrolment to be completed in the secondhalf of calendar 2008. The North American trial involves patients with nonmuscle-invasive bladder cancer that is refractory (unresponsive) to bacillusCalmette-Guerin (BCG) therapy. BCG, the standard of care for nonmuscle-invasive bladder cancer, has limited efficacy, especially assecond-line therapy. It is associated with a number of treatment-limiting sideeffects that include the potential for both local (bladder) and systemicmycobacterial infections.
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The Data Safety Monitoring Committee held its fourth scheduled meetingregarding this clinical trial on May 8, 2008. The role of this independentbody is to confirm that the safety of enrolled patients is being appropriatelyaddressed and that, from an efficacy point of view, there is an appropriatebasis for continuing the trial. After its meeting, the Committee hasrecommended that Bioniche "continue the trial unmodified until the nextscheduled or triggered meeting". The next scheduled meeting of the Committeewill be held in three months.
A number of additional investigational sites have been added to the trial.These are: Towson, Maryland; Dallas, Texas; Poughkeepsie, New York;Evansville, Indiana; Pittsburgh, Pennsylvania; La Mesa, California; and GardenCity, New York. "We are pleased to have an additional seven clinical sites andinvestigators participating in our first Phase III clinical trial with MCC,"said Dr. Francois Charette, Chief Medical Officer at Bioniche Life SciencesInc. "With a total of 32 sites participating, we expect that the speed ofenrolment will increase and our goal of full enrolment before year-end will beachieved."
The data collected from this 105-patient trial, when coupled withadditional safety information collected from a second trial, will allow fullresults to be reported approximately one year after recruitment is completedfor the efficacy and safety datasets. These results may also supportregulatory submissions under FDA's Accelerated Approval program. Thisindication was given Fast Track designation by the U.S. Food and DrugAdministration (FDA) in April of 2006. The Company commenced this trial inNovember, 2006. An investigators' meeting was held in April, 2007 and the 25thsite validated in September, 2007. The trial has been progressing throughoutthis time.
Bioniche is planning to conduct a second registration trial which willdirectly compare the efficacy and safety of MCC with BCG in the treatment ofnon muscle-invasive bladder cancer. In September, 2007, the Company announcedthat an agreement has been reached with the U.S. Food and Drug Administration(FDA) under the Special Protocol Assessment (SPA) procedure on the design ofthe trial, including its endpoints, data analysis and conduct. It providesassurance that, if the trial endpoints are met, they will serve as the basisfor product approval under a Biologics Licensing Application (BLA). An SPAgives a clear pathway to registration of MCC when the trial endpoints areachieved. This study received Fast Track designation by the FDA in February ofthis year.
Bioniche plans to begin recruitment of patients for the second pivotaltrial later this year. The trial will enrol approximately 800 patients and isa double-blind, randomized trial.
Bioniche Life Sciences Inc. was among the presenters at the 4th CanadianCon
