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Human Genome Sciences Completes Enrollment in Second Phase 3 LymphoStat-B(R) Trial
Date:8/27/2008

- First Phase 3 data, from BLISS-52 trial, expected by mid-2009 -

- Data from second Phase 3 trial, BLISS-76, expected by fall 2009 -

ROCKVILLE, Md., Aug. 27 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced it has completed enrollment and initial dosing in BLISS-76, the second of two pivotal Phase 3 randomized clinical trials of LymphoStat-B(R) (belimumab) in patients with active systemic lupus erythematosus (SLE). Belimumab is being developed by HGS and GlaxoSmithKline (GSK) under a co-development and commercialization agreement entered into in August 2006.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080416/HGSLOGO )

"If LymphoStat-B is successful in Phase 3, we believe that it could represent a breakthrough in the treatment of patients suffering from SLE," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "We have now completed enrollment in both of our LymphoStat-B Phase 3 trials. We are on track to have data from our first Phase 3 trial by mid-2009, and data from our second Phase 3 trial by fall 2009. Assuming positive results, we anticipate a BLA filing in the United States in the first half of 2010."

BLISS-76 was initiated in February 2007, and has enrolled and randomized 826 patients at 133 clinical sites in 19 countries, primarily in North America and Europe. In April 2008, BLISS-52, the first of the two belimumab Phase 3 trials, completed the enrollment of 867 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe.

"The BLISS studies are the largest double-blinded clinical trials ever conducted in lupus," said J
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SOURCE Human Genome Sciences, Inc.
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