July 20, 2009 - Shares of Human Genome Sciences Inc. (HGSI) are exploding higher this morning after positive data on their Lupus Drug is getting rave reviews! HGSI stock is up 209% to $10.25. Discuss HGSI
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HUMAN GENOME SCIENCES AND GLAXOSMITHKLINE ANNOUNCE POSITIVE PHASE 3 STUDY RESULTS FOR BENLYSTA™
BENLYSTA (belimumab) met its primary efficacy endpoint by achieving a statistically significant improvement in patient response rate versus placebo in BLISS-52 -
- First drug for lupus to reach this advanced stage of clinical development and achieve positive results, in the largest randomized placebo-controlled clinical trial ever completed in SLE patients
ROCKVILLE, Maryland, and LONDON, UK – July 20, 2009 – Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced that BENLYSTA™ (belimumab, formerly LymphoStat-B®) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone. Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups.
“The BLISS-52 results demonstrated that BENLYSTA has the potential to become the first new approved drug in decades for people living with systemic lupus,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “Given the limited treatment options currently available, patients would benefit greatly from potential new treatments. BENLYSTA is an outstanding example of the type of treatment HGS is working to develop and bring to patients. Assuming positive results in November from our second Phase 3 trial of BENLYSTA, we and GSK plan to submit marketing applications in the United States, Europe and other regions in the first half of 2010.” Full Article Here
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