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www.fdanews.com/articles/81412-human-genome-s-lupus-drug-misses-main-goal

HUMAN GENOME'S LUPUS DRUG MISSES MAIN GOAL

October 5, 2005

Human Genome Sciences has announced that its experimental lupus drug failed to meet main targets in a midstage study.

A 449-patient, Phase II trial of the monoclonal antibody LymphoStat-B showed the drug was safe and well tolerated, but it did not meet primary efficacy goals. The trial was designed to evaluate the drug in patients with systemic lupus erythematosus, or SLE, a form of lupus that is diagnosed in 200,000 to 500,000 Americans.

The drug failed to reduce signs and symptoms of the disease after 24 weeks and did not increase the time to the first "flare" of the disease at 52 weeks -- primary goals of the trial. But the drug did significantly reduce the signs and symptoms of the disease at 52 weeks in a subgroup of patients representing 75 percent of the study's patient population.