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Lupus Research Institute Highly Encouraged by Benlysta(TM) Trial Results
Date:7/19/2009

First Phase 3 Lupus Drug Trial in Decades to Show Effectiveness

NEW YORK, July 20 /PRNewswire-USNewswire/ -- The Lupus Research Institute (LRI) and its National Coalition of state and local organizations congratulate Human Genome Sciences (HGS) and GlaxoSmithKline on the highly promising results of this landmark clinical trial of Benlysta(TM) (belimumab) for people with systemic lupus.

"We are very hopeful that we now are strongly on our way to the first new treatment for lupus in 50 years," said LRI President, Margaret G. Dowd. "We look forward to the impact that a new drug for lupus will have on the lives of the 1.5 million Americans, and millions more worldwide, who suffer from this devastating autoimmune illness."

"This is a major advance for patients, families, and physicians--the entire lupus community!" said Richard Furie, MD, chief of the division of rheumatology and allergy-clinical rheumatology at North Shore-LIJ Health System in New York. "There is no doubt that a drug approval will foster further drug development and additional discoveries."

In the double-blind, placebo-controlled, multi-center trial, known as BLISS-52, both dose levels of Benlysta(TM) plus standard of care were more effective than a placebo plus standard of care in people with serologically active systemic lupus. A total of 867 participants at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe, were enrolled in the trial.

"This is the first drug shown to be effective in ameliorating the signs and symptoms of lupus in decades," said Daniel J. Wallace, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA. "It represents a breakthrough for finally utilizing a methodology that enables researchers to demonstrate disease improvement. This will benefit lupus patients and their doctors."'/>"/>

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