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news.Canadian biopharmaceutical company Bioniche Life Sciences has reached an agreement with the FDA over the design of its pivotal Phase III study using its drug candidate in non muscle-invasive bladder cancer at high risk of recurrence or progression.
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Bioniche said that the agreement had been reached under the FDA's special protocol assessment (SPA) procedure. The company plans to evaluate its proprietary mycobacterial cell wall-DNA complex (MCC), a sterile mycobacterial cell wall and DNA composition that has a dual mode of action – immune stimulation and direct anticancer activity. It is formulated as Urocidin for the treatment of bladder cancer, where it is administered by catheter directly into the bladder, coming into contact with immune system cells and bladder cancer cells.
Cindy Benning, vice-president of operations, quality and regulatory affairs of Bioniche Life Sciences, said: “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. A SPA gives a clear pathway to registration of Urocidin when the study endpoints are achieved.”
Bioniche plans to begin recruitment of patients for the second pivotal study in Q1, calendar 2008. The study will enroll 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-Guerin (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.