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Pivotal Phase III Trial Showed Promacta (eltrombopag olamine),Raised Platelet Counts and Reduced Bleeding in Patients With,Chronic ITP

VIENNA, Austria, June 11, 2007 /PRNewswire/ -- GlaxoSmithKline plc announced results from an international, pivotal Phase III study of its investigational non-peptide oral platelet growth factor, PROMACTA(R) (eltrombopag olamine). Data from this study showed that PROMACTA at 50-75mg once daily resulted in a statistically significant increase in platelet counts and also reduced bleeding in adult patients with chronic idiopathic thrombocytopenic purpura (ITP). These patients had previously received and failed current standard ITP treatments. These data, which are part of a six-week study of PROMACTA in patients with chronic ITP, were presented at the 12th congress of the European Hematology Association (EHA) in Vienna, Austria.(1)

"ITP is a condition that can be serious for some individuals, or those who fail to respond to therapy and not only puts patients at risk of bleeding, but may also cause severe fatigue, bruises and complications during surgery or pregnancy," says Drew Provan, M.D., Senior Lecturer in Hematology, Department of Hematology, Royal London Hospital, U.K. and investigator for this trial. "Options are particularly limited for those patients who fail to respond to primary treatment altogether and those who initially respond and then fail. These trial results demonstrate that PROMACTA may represent the potential for a new oral therapy to reduce the number of bleeding episodes in ITP patients."

There are estimated to be between 50,000-100,000 individuals diagnosed with chronic ITP in the U.S. In Europe, primary ITP is estimated to affect 50 to 100 new persons per million per year.(2) People with ITP often bleed from small blood vessels causing bruises, nosebleeds, bleeding from the gums during dental work or other bleeding that is difficult to stop. The predicted five- year mortality rates for ITP patients with persistent low platelet counts range from 2.2% for patients younger than 4
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