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The Company commenced this trial in November, 2006. An investigators'meeting was held in April, 2007, and the trial has been progressing steadilysince that time.
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On February 7, 2008, the Data Safety Monitoring Committee held its thirdmeeting regarding this clinical trial. The role of this independent body is toconfirm that the safety of enrolled patients is being appropriately addressedand that, from an efficacy point of view, there is an appropriate basis forcontinuing the trial. After its meeting, the Committee has recommended thatBioniche "continue the trial unmodified until the next scheduled or triggeredmeeting." The next meeting of the Committee will be held in three months.
Patients are being enrolled in the trial's 25 sites on a regular basis.The targeted enrollment of this study is 105 patients which, coupled withadditional safety information collected from a comparative trial, will allowfull results to be reported one year after recruitment is completed for theefficacy and safety datasets. These results may also support regulatorysubmissions under FDA's Accelerated Approval program.
Bioniche is planning to conduct a second registration study in bladdercancer; a trial which will directly compare the efficacy of Urocidin with theincumbent therapy for non muscle-invasive bladder cancer. In September, 2007,the Company announced that an agreement has been reached with the U.S. Foodand Drug Administration (FDA) under the Special Protocol Assessment (SPA)procedure. This indicates agreement by the FDA on the design of the study,including its endpoints, data analysis and conduct. It provides assurancethat, if the trial endpoints are met, they will serve as the basis for productapproval under a Biologics Licensing Application (BLA). A SPA gives a clearpathway to registration of Urocidin when the study endpoints are achieved.
Bioniche plans to begin recruitment of patients for the second pivotalstudy later this year. The study will enrol approximately 800 patients inNorth America, Australia and Europe and is a double-blind, randomized study.It will compare MCC to the standard treatment for non muscle-invasive bladdercancer at high risk of recurrence or progression - Bacillus Calmette-Guerin(BCG). BCG is a live, attenuated strain of Mycobacterium bovis and is oftenassociated with treatment-limiting side effects including active bacterialinfections.
Bioniche also continues to have discussions with potential development andmarketing partners, and the Company is well positioned and committed toexecute a strategic partnership transaction related to the financing ofUrocidin at the earliest opportunity.
About MCC
MCC is a sterile mycobacterial cell wall composition that has a dual modeof action: immune stimulation and direct anticancer activity. It is formulatedas Urocidin(TM) for the treatment of bladder cancer, where it is administeredby the intravesical route directly into the bladder, coming into contact withimmune system cells and bladder cancer cells. MCC is also undergoingpreclinical evaluation as a treatment for peritoneal carcinomatosis associatedwith colon and ovarian cancer.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-drivenCanadian biopharmaceutical company focused on the discovery, development,manufacturing, a
