Bioniche Life Sciences Inc. announced that its first Phase III clinical trial with a formulation of Mycobacterial Cell Wall-DNA Complex (MCC), trademarked Urocidin, for the treatment of bladder cancer, is progressing well.
The Data Safety Monitoring Committee held its fifth scheduled meeting regarding this clinical trial on August 14, 2008. The role of this independent body is to confirm that the safety of enrolled patients is being appropriately addressed and that, from an efficacy point of view, there is an appropriate basis for continuing the trial. After its meeting, the Committee has again recommended that Bioniche "continue the trial unmodified until the next scheduled or triggered meeting". The next scheduled meeting of the Committee will be held in three months.
The protocol calls for 105 evaluable patients to be enrolled this trial. These are patients with non-muscle-invasive bladder cancer that is refractory (unresponsive) to bacillus Calmette-Guérin (BCG) therapy. BCG, the standard of care for non-muscle-invasive bladder cancer, has limited efficacy, especially as second-line therapy. It is associated with a number of treatment-limiting side effects that include the potential for both local (bladder) and systemic mycobacterial infections. The Company expects patient enrolment to be completed by the end of calendar 2008.
Thirty-one investigational sites across North America are involved in this clinical trial. Sites include: The Centre for Applied Urological Research (Kingston, Ontario); Memorial Sloan-Kettering Cancer Center (New York, New York); Johns Hopkins Brady Urological Institute (Baltimore, Maryland); M.D. Anderson Cancer Center (Houston, Texas); and Sunnybrook Health Science Centre (Toronto, Ontario).
The data collected from this 105-patient trial, when coupled with additional safety information collected from a second clinical trial, will allow full results to be reported approximately one year after recruitment is completed for the efficacy and safety datasets. These results may also support regulatory submissions under FDA's Accelerated Approval program. This indication was given Fast Track designation by the U.S. Food and Drug Administration (FDA) in April of 2006. The Company commenced this trial in November, 2006. An investigators' meeting was held in April, 2007 and the 31st site was validated in June, 2008.
Bioniche is planning to conduct a second registration trial which will directly compare the efficacy and safety of MCC with BCG in the treatment of non-muscle-invasive bladder cancer. In September, 2007, the Company announced that an agreement has been reached with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure on the design of the trial, including its endpoints, data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a Biologics Licensing Application (BLA). An SPA gives a clear pathway to registration of MCC when the trial endpoints are achieved. This study received Fast Track designation by the FDA in February of
Bioniche plans to begin recruitment of patients for the second pivotal trial later this year. The trial will enrol approximately 800 patients and is a double-blind, randomized trial.