Lupus Research Institute: Benlysta(TM) Trial Results in an Historic Research Breakthrough and Victory for People With Lupus

Lupus Research Institute: Benlysta(TM) Trial Results in an Historic Research
Breakthrough and Victory for People With Lupus

Second successful phase III trial points to the first new lupus treatment in
over 5O years.

NEW YORK, Nov. 2 /PRNewswire-USNewswire/ -- The Lupus Research Institute (LRI)
and its National Coalition of state and local lupus organizations congratulate
Human Genome Sciences (HGS) and GlaxoSmithKline for achieving an historical
landmark - the second positive phase 3 clinical trial of Benlysta (belimumab),
the first successfully tested new drug developed specifically for people with
systemic lupus.

"This is a pivotal moment in lupus research," said Margaret G. Dowd, president
of the LRI, an organization that pioneers discovery in lupus. "It demonstrates
the power of innovative science to drive discovery and achieve solid clinical
results in the complex autoimmune disease of lupus. Benlysta represents new
hope for the 1.5 million Americans with lupus and millions more worldwide who
have suffered without a safe and effective treatment for more than 50 years."

"This is spectacular news for the world-wide lupus community," said Tammy O.
Utset, MD, MPH, an associate professor of medicine at the University of
Chicago. "These trials demonstrate that SLE can be studied successfully in a
clinical trial setting and should encourage further interest in drug
development for lupus, an area of great unmet need. Further, these two large,
well-designed trials will allow Benlysta, the first biological agent for the
treatment of SLE, to be submitted to the FDA for potential approval."

The trial was the second double-blind, placebo-controlled, multi-center study
of Benlysta. Known as BLISS-76, the trial enrolled and randomized 826 patients
at 133 clinical sites in 19 countries, primarily in North America and Europe.

"Combining the results of this study with the previous successful BLISS-52
study will yield a very large dataset that will allow a better understanding
of lupus, the instruments to measure lupus activity, and the responses to
treatment," explained Richard Furie, MD, chief of the division of rheumatology
and allergy-clinical rheumatology at North Shore-LIJ Health System in New
York. "And most important, the two positive trials will allow Human Genome
Sciences and GlaxoSmithKline to file for drug approval with regulatory
agencies around the world."

"The Benlysta trials are the first well-designed and conducted, comprehensive
studies that assessed several measurements of disease," said Daniel J.
Wallace, MD, clinical professor of medicine at the David Geffen School of
Medicine at UCLA. "These trials are a breakthrough for utilizing a methodology
that enables researchers to demonstrate disease improvement, and represent a
solid path forward for people with lupus."

"As the organization uniquely dedicated to funding bold approaches to novel
research in lupus, the Lupus Research Institute commends HGS and GSK for their
commitment and courage in pursuing innovative science, state of the art
technology, and smart trial design which has put Benlysta on the road to
become the first new drug for lupus that can potentially win FDA approval and
start to roll out to physicians and patients," said Dowd.

The LRI funds innovative and creative research to discover new scientific
solutions for lupus, and assists in recruiting patients to participate in
trials to bring safe and effective treatments to market for people with lupus.

"We thank the hundreds of people with lupus who enrolled and took part in
these important trials," Dowd said.

To learn more about lupus clinical trials, visit LupusTrials.org.

SOURCE Lupus Research Institute

Media, Liane Stegmaier of Lupus Research Institute, +1-212-685-4118,
lstegmaier@lupusny.org; or Mary McConnell, +1-646-256-8791,
marygmcconnell@gmail.com