HGSI's Benlysta Trial Results in Historic ResearchBreakthrough Print E-mail
By Staff and Wire Reports   
Monday, 02 November 2009 03:00

Human Genome Sciences, Inc. (Nasdaq:HGSI) and GlaxoSmithKline PLC (GSK) today announced that BENLYSTA™ (belimumab) - which is being developed as the first new Lupus treatment in 50 years- met the primary endpoint in BLISS-76, the second of two pivotal Phase 3 trials.

"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."

In seropositive patients with systemic lupus erythematosus (SLE). BLISS-76 study results through 52 weeks showed that belimumab 10 mg/kg plus standard of care achieved a statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care. Study results also showed that belimumab was generally well tolerated, as demonstrated by a similar rate of discontinuations due to adverse events across treatment groups, with overall adverse event rates comparable between belimumab and placebo treatment groups.

Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK, said, “The results from this second pivotal Phase 3 trial reinforce our belief that belimumab could deliver a significant therapeutic option for patients with lupus who have had no new treatment in fifty years. We look forward to continuing our collaboration with HGS in order to bring this important medicine to patients.”

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.



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