The special protocol assessment (SPA) is a process that allows for official FDA evaluation of a phase III clinical trial and provides the trial sponsor with binding written agreement that the design and analysis of the study are adequate to support a license application submission if the study is performed according to the SPA.
“We reached agreement with FDA on the clinical trial design several months ago and have now successfully addressed the remaining manufacturing and product characterization questions raised by the FDA with regard to the trial that would delay the start of the study,” said Dr Jean-Loup Romet-Lemonne, chairman & CEO of IDM Pharma.
The randomized, controlled, multi-center pivotal trial will include approximately 300 patients with superficial bladder cancer with a history of failure of BCG therapy. The primary endpoint is time to recurrence. The company already has a phase II/III trial of Bexidem for superficial bladder cancer ongoing in Europe.