The meeting between Protein Design Labs (PDL) and the FDA was to discuss the future development pathway for PDL’s Nuvion (visilizumab) humanized anti-CD3 antibody being developed for the treatment of intravenous steroid-refractory ulcerative colitis.
As a result of these discussions, PDL is now considering conducting two pivotal clinical trials of Nuvion, a phase II/III clinical trial and a phase III clinical trial, as well as a retreatment study. The first of the pivotal trials is expected to begin this year, at the same time as the retreatment study.
Based on this development pathway, the company will not be pursuing a special protocol assessment, although the FDA will make a detailed review of the proposed protocols.
“Over the next weeks, we expect to more fully refine the development plan and its impact on the overall development timeline, but anticipate that the time to complete the proposed registrational studies will be longer than we have previously hoped,” commented Dr Steven Benner, senior vice president and chief medical officer at PDL. “We expect to provide a further development update by the end of May 2005.”