Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, announced that an agreement has been reached with the US FDA under the 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. 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," said Cindy Benning, vice-president of operations, quality and regulatory affairs, Bioniche Life Sciences Inc.
"This second pivotal trial will provide first-line bladder cancer patients with access to Urocidin," said Dr. Francois Charette, chief medical officer, 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", he added.
"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 and CEO, Bioniche Life Sciences Inc.
Bioniche plans to begin recruitment of patients for the second pivotal study in Q1, 2008. The double blind, randomized study will enrol approximately 800 patients in North America, Australia and Europe. It will compare MCC to the standard treatment for non muscle-invasive bladder cancer at high risk of recurrence or progression - Bacillus Calmette-Guérin (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. 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.