GlaxoSmithKline begins eltrombopag phase 3 trial in adults with blood disorder

By Lisa Kerner

Erie, Pa., Feb. 14 - GlaxoSmithKline plc said it is beginning a worldwide clinical trial to investigate the safety and efficacy of eltrombopag (SB-497115-GR) as a once-daily orally administered drug for adult patients with previously treated idiopathic thrombocytopenic purpura (ITP).

According to a company news release, ITP is characterized by low platelet counts leaving patients at risk for spontaneous bruising, mucosal bleeding and intracranial hemorrhage.

Eltrombopag is an investigational small-molecule thrombopoietin receptor agonist believed to stimulate the proliferation of bone marrow cells that give rise to blood platelets.

Patients in the double-blind, placebo-controlled study will be randomized to receive either eltrombopag or a placebo once daily for six weeks, the company said. The study population will be adults with ITP diagnosed at least six months prior to screening, with platelet counts of less than 30,000/microL, who have not responded to previous treatment or have relapsed within three months of previous treatment.

Patients achieving a platelet count of greater than or equal to 50,000/microL after 42 days of dosing will be considered treatment responders.

Top line results of the phase 2 trial in ITP, which tested various dosing levels, were reported in December. The phase 2 study of 97 patients found that eltrombopag, at doses of 75 mg and 50 mg, compared with a placebo, was successful in increasing platelet count from a baseline of less than 30,000/microL to at least 50,000/microL after 42 days of dosing.

GlaxoSmithKline is a research-based pharmaceutical and health care company based in London.

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