Immunomedics, Inc, reported encouraging initial safety and clinical efficacy results from its open-label, non-randomized, Phase I/II trial of epratuzumab for the treatment of patients with Sjogren's syndrome (ss). The trial of the B-cell-depleting drug was conducted by Serge D. Steinfeld MD, PhD, professor at Erasme University Hospital in Brussels, Belgium. Fifteen patients with primary SS received an infusion of epratuzumab every 2 weeks over an 8-week period. A 50% to 60% reduction in circulating B cells was observed following treatment, and symptomatic improvements included a reduction in tender joints and increased salivary flow, which were maintained in some patients up to 12 weeks posttreatment. One patient experienced an acute infusion reaction during the third dose, but completed the fourth infusion without incident. A final evaluation is planned for 6 months posttreatment.

Starts Phase III trial for lupus

IEpratuzumab, a humanized antibody targeting the CD22 antigen on B cells, has also shown good safety, tolerability, and clinical activity in more than 340 patients with indolent and aggressive non-Hodgkin's lymphoma, and in patients with moderate-to-severe systemic lupus erythematosus (SLE). The US Food and Drug Administration recently granted its Fast Track Product designation to epratuzumab for the treatment of patients with moderate to severe SLE, and Immunomedics just launched two pivotal Phase III studies of epratuzumab for this indication. The trials are randomized, double-blinded, placebo-controlled, multicenter studies using the BILAG (British Isles Lupus Assessment Group) index to monitor and assess disease activity. ALLEVIATE A will evaluate epratuzumab in patients with severe SLE flares, while ALLEVIATE B will include patients with moderately active disease.