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Biotech / Medical : Ligand (LGND) Breakout!
LGND 186.64-2.0%Feb 9 3:59 PM EST

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From: nigel bates6/13/2014 9:32:32 AM
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Ligand Pharmaceuticals Incorporated ( LGND) announces that its partner, GlaxoSmithKline (GSK) plc, presented the results from the Phase 3 PETIT2 study evaluating the efficacy of eltrombopag vs. placebo in pediatric patients with chronic immune (idiopathic) thrombocytopenic purpura (cITP). Eltrombopag - marketed as Promacta™ in the U.S. and as Revolade™ in Europe and other countries across the world - met its primary endpoint, achieving a statistically significant improvement in platelet counts with almost 40 percent of patients treated with eltrombopag attaining a consistent platelet response for 6 of 8 weeks compared to placebo (39.7 percent vs. 3.4 percent, respectively, p

The PETIT2 study results were highlighted today as part of a Press Briefing and Oral Presentation at the European Hematology Association Annual Congress in Milan, Italy.

GSK also announced that it is moving forward with planned regulatory submissions for a pediatric indication in cITP later this year.

Efficacy results for PETIT2 were consistent across age cohorts. The safety profile was consistent with the established profile for eltrombopag and no new safety concerns were observed. The most common adverse events (AEs) occurring most frequently in the eltrombopag arm included nasopharyngitis, rhinitis, cough and respiratory tract infection. Grade 3/4 AEs occurred in 12.7 percent of patients treated with eltrombopag and 10.3 percent of patients in the placebo group. Serious AEs were reported in 8 percent of eltrombopag-treated patients vs. 14 percent in the placebo arm.

Additional results from an early phase study of eltrombopag in previously treated pediatric patients with cITP were also presented at the European Hematology Association Annual Congress.
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