Lupus Research Institute: News on Possible Drug for Lupus—Benlysta™

Human Genome Sciences (HGS) and GlaxoSmithKline Report Topline Results of 76-Week, Phase 3 Study

New York, NY, April 22, 2010 --( The beneficial effects of the proposed lupus drug Benlysta™ (belimumab) are not only present after 52 weeks, but persist through at least 76 weeks, HGS and GlaxoSmithKline reported Tuesday.

It was last July and November that the companies reported that high doses of Benlysta were statistically significantly superior to placebo in benefiting people with systemic lupus in two major 52-week clinical trials—a major advance for a chronic and potentially fatal illness which has had no new drug approved in 50 years.

Now results at 76 weeks show that Benlysta™ continues to do better for most trial participants than placebo—38.5% of patients responded to high dose Benlysta™ compared to 32.4% of those taking a placebo—but not to the point of statistical significance in what were considered secondary endpoints.

“The Lupus Research Institute is gratified to see that the benefits of this experimental lupus drug at Week 52 persisted through to Week 76 for many participants, and that no new safety issues arose over this longer time period,” said Margaret G. Dowd, president of the LRI.

“People with lupus and their families have been waiting a very long time for better treatments and a cure,” Dowd said. “Altogether, the findings on this investigational human monoclonal antibody drug —specifically the positive results of the two large Phase 3 trials reported last year—provide the basis for the first approval of a new lupus drug in half a century.”

About the Lupus Research Institute:

Pioneering discovery to prevent, treat, and cure lupus.

The Lupus Research Institute (LRI) is the world’s leading private supporter of innovative research in lupus. The LRI champions scientific creativity and risk-taking in the hunt for solutions to this complex and dangerous autoimmune disease. Founded by families and shaped by scientists, the LRI mandates sound science and rigorous peer review to uncover and support only the highest-ranked novel research. It is the only lupus organization to receive an A+ rating by the American Institute of Philanthropy, directly channeling 94 cents of every dollar donated right back to the programs supporting brilliant and determined lupus researchers. The LRI’s bold and proven research strategy consistently achieves the insights, breakthroughs, and solid results that are changing the course of lupus research and bringing new hope to people with lupus nationwide and around the world.

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Liane Stegmaier