- Completion of enrollment in second Phase 3 trial expected by end of
- First Phase 3 data now expected by mid-2009, with all Phase 3 data
expected in fall 2009 -
ROCKVILLE, Md., April 22 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has completed enrollment and initial dosing in BLISS-52, one of two pivotal Phase 3 clinical trials of LymphoStat-B(R) (belimumab) in patients with active systemic lupus erythematosus (SLE). LymphoStat-B is being developed by HGS and GlaxoSmithKline (GSK) under a co-development and commercialization agreement entered into in August 2006.
"We continue to be excited by LymphoStat-B's potential. Assuming it is successful in Phase 3, we believe that LymphoStat-B could represent a breakthrough in the treatment of SLE," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "With enrollment now completed in the BLISS-52 trial, we are on track to have our first Phase 3 data for LymphoStat-B available by mid-2009, and all Phase 3 data available in fall 2009."
BLISS-52 was initiated in May 2007, and has enrolled and randomized a
total of 867 patients at 90 clinical sites in 13 countries, primarily in
Asia, South America and Eastern Europe. Completion of enrollment for the
other pivotal Phase 3 trial of belimumab, BLISS-76, is expected by the end
of summer 2008. BLISS-76, which was initiated in February 2007, is being
conducted primarily in North America and Europe, and will enroll and
randomize a minimum of 810 sub
|SOURCE Human Genome Sciences, Inc.|
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