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news.Human Genome Sciences has completed enrollment and initial dosing in BLISS-52, one of two pivotal Phase III clinical trials of LymphoStat-B in patients with active systemic lupus erythematosus.
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BLISS-52 was initiated in May 2007, and has enrolled and randomized a total of 867 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe. Completion of enrollment for the other pivotal Phase III trial of belimumab, BLISS-76, is expected by the end of summer 2008. BLISS-76, which was initiated in February 2007, is being conducted primarily in North America and Europe, and will enroll and randomize a minimum of 810 subjects.
In each of the two Phase III trials, patients are randomized to one of three treatment groups: 1mg/kg belimumab, 10mg/kg belimumab, or placebo. Patients are dosed intravenously on days 0, 14 and 28, then every 28 days for the duration of the study. All receive standard of care therapy in addition to study medication. Safety and tolerability are evaluated by an independent data monitoring committee throughout both studies.
LymphoStat-B is being developed by HGS and GlaxoSmithKline (GSK) under a co-development and commercialization agreement entered into in August 2006.
Thomas Watkins, president and CEO of Human Genome Sciences (HGS), said: “With enrollment now completed in the BLISS-52 trial, we are on track to have our first Phase III data for LymphoStat-B available by mid-2009, and all Phase III data available in fall 2009.”