Protein Design Labs Reports on Nuvion End-of-Phase-I Meeting With FDA
Protein Design Labs (PDL) has discussed with the FDA the future development pathway for PDL's Nuvion humanized anti-CD3 antibody being developed for the treatment of intravenous steroid-refractory ulcerative colitis.
PDL is currently conducting a Phase I/II clinical trial of Nuvion (visilizumab) in patients with intravenous steroid-refractory ulcerative colitis.
The Phase I portion of the trial was designed to explore four dose levels at 5, 7.5, 10 or 12.5 mcg/kg administered intravenously on days one and two as a bolus injection. Up to 20 patients per dose cohort will be enrolled, with up to an additional 40 patients to be enrolled in the Phase II portion of the trial, for an expected total of approximately 120 patients treated.
PDL is now enrolling visilizumab-naive patients in the Phase II component of the study at the 5-mcg/kg dose level, administered on days one and two.