Shares of HGSI up in anticipation of clinical trials update |
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| By M.E.Garza | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Thursday, 16 July 2009 10:50 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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On 6/11/09, BioMedReport's Mike Havrilla informed our readers that Human Genome Sciences had announced Phase 2 continuation data which demonstrated sustained improvement in disease activity and patient response rate through four years of BENLYSTA therapy in combination with standard of care in patients with serologically active systemic lupus erythematosus (SLE). The frequency of disease flares as measured by the SELENA SLEDAI flare index and by BILAG A or B organ domain scores decreased over four years of BENLYSTA therapy and there was no increase in overall adverse events, serious adverse events, malignancies or serious infections over time. Today, shares are rising on "no published news," but our subscribers and readers know that an important development is coming. HGSI and GlaxoSmithKline (NYSE:GSK) have selected BENLYSTA as the brand name for belimumab (formerly known as LymphoStat-B). HGS and GSK expect to report the first Phase 3 data for BENLYSTA in July 2009 from the BLISS-52 trial, with results from BLISS-76 anticipated in November 2009. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients. On 7/1/09, HGSI announced that it expects to have top-line results available on 7/20/09 for BLISS-52, the first of two pivotal Phase 3 clinical trials of BENLYSTA in systemic lupus erythematosus (SLE). HGSI will host a conference call to discuss the results on 7/20/09 at 8:15 a.m. ET. Some analysist have said that the odds against positive results for BENLYSTA are stacked against HGSI. Here are the rest of the movers at mid day on Thusday, July 16, 2009:
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Shares of Human Genome Sciences (
