• Relative to the 12-week, double-blind EMBLEM™ study, primary outcome data from the open-label extension identified no new safety or tolerability signals 1 • Relative to EMBLEM™ baseline, secondary outcome data from the open-label extension indicated that the efficacy of epratuzumab, as measured by reduction in disease activity, was maintained for over two years 2 • Relative to EMBLEM™ baseline, secondary outcome data indicated that treatment over two years with epratuzumab was associated with decreases in corticosteroid use in patients receiving >7.5 mg/day 1 • Epratuzumab is an investigational medicine in clinical development and is not approved for the treatment of systemic lupus erythematosus (SLE) 3
MORRIS PLAINS, N.J., June 13, 2013 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU),a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today reported that UCB (Brussels:UCB), announced new data from an open-label extension (SL0008) of the EMBLEM™ phase 2b study evaluating the long-term effects of epratuzumab treatment in adult patients with moderate-to-severe systemic lupus erythematosus (SLE). The primary outcome of outcome of the open-label extension was to assess the safety of epratuzumab in patients with SLE. 4
Relative to the 12 week, double-blind, placebo-controlled EMBLEM™ study, data from the open-label, long-term extension identified no new safety or tolerability signals. 1 In addition, relative to EMBLEM™ baseline values, secondary outcome data indicated that the efficacy of epratuzumab as measured by reduction in disease activity was maintained over two years. 2 Secondary outcome data also indicated that relative to EMBLEM™ baseline values, treatment over two years with epratuzumab was associated with decreases in corticosteroid use in patients receiving >7.5 mg/day. 1 These data were presented this week at the European League Against Rheumatism 2013 Congress in Madrid, Spain.Epratuzumab, licensed from the Company to UCB, is an investigational medicine and the first CD-22/B-Cell receptor (BCR) targeted monoclonal antibody to be evaluated in clinical studies for the treatment of SLE. Also known as lupus, SLE is a complex, systemic autoimmune disease that affects many different organ systems, including the skin, joints, lungs, kidneys and blood. 3,5 "In EMBLEM™, a dose-ranging, phase 2b study, reduction in disease activity was observed in patients treated with epratuzumab," said Professor Daniel J Wallace MD, Clinical Professor of Medicine, Cedars-Sinai Medical Center, California, US. "This double-blind study had a relatively short 12-week, placebo-controlled, treatment period and it was important to accumulate long-term data on epratuzumab in the treatment of SLE. The phase 2b extension study adds new two year open-label data on epratuzumab to that already available from the 12-week, randomized, controlled study."