Bioniche Reaches Special Protocol Assessment Agreement with U.S. FDA for Phase III Comparative Bladder Cancer Trial
- this second pivotal study targeted to commence in Q1, calendar 2008 -
- conference call/audio webcast on Wednesday, September 12, 2007 at 9:30 a.m. ET to discuss -
BELLEVILLE, ON, Sept. 10 - Bioniche Life Sciences, a research-based, technology-driven Canadian biopharmaceutical company, today 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.
"This is a major milestone for the Company," said Cindy Benning, Vice-President of Operations, Quality and Regulatory Affairs of Bioniche Life Sciences Inc. "It indicates agreement by the FDA on the design of the study, 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). A SPA gives a clear pathway to registration of Urocidin(TM) when the study endpoints are achieved."
"This second pivotal trial will provide first-line bladder cancer patients with access to Urocidin," stated Dr. Francois Charette, Chief Medical Officer of Bioniche Life Sciences Inc. "With our ongoing pivotal trial in treatment-refractory bladder cancer, this study will add further insight into the efficacy and safety of Urocidin."
"Our regulatory and clinical teams have worked closely with the FDA's Centre for Biologics Evaluation and Research (CBER) to ensure that we have a well-controlled and adequately designed study to clearly demonstrate the efficacy and safety of our product," said Mr. Graeme McRae, President & CEO of Bioniche Life Sciences Inc.
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-GuÃ©rin (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.
Dr. Alvaro Morales, Professor of Urology and Oncology at Queen's University in Kingston, Ontario is the International Principal Investigator for this Urocidin pivotal trial. He previously served as the Principal Investigator in the Company's Phase I/II bladder cancer study with this technology. Dr. Morales is well-known in the North American and International urology communities, having served on numerous boards and committees, including the Research Committee of the American Urological Association/American Foundation for Urologic Disease, which he joined in 1987. Dr. Morales is widely credited with the introduction of BCG as the current standard of care in high-risk bladder cancer. Dr. Harry Herr, from Memorial Sloan-Kettering Cancer Center in New York is the North American Principal Investigator.
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.
"We are pleased with the progress we are making on this refractory study," added Dr. Charette. "We have 25 North American sites involved and all are actively screening patients. Urologists are also looking forward to the beginning of our large comparative trial and have expressed a high interest in participating."