GSK starts dosing study of platelet drug

Chronic idiopathic thrombocytopenic purpura (ITP) is a condition characterized by increased autoimmune platelet destruction and inadequate platelet production.

The primary objective of the study is to evaluate the effect of Promacta on platelet counts during three consecutive treatment cycles. Secondary objectives include evaluating incidence and severity of bleeding, as well as the frequency of adverse events.

“The current treatment approaches to acutely increase the platelet count typically include treatment with steroids or IV gammaglobulin, both of which may have issues with tolerability or safety,” said James Bussel, director of the Platelet Disorders Center, Children's Blood Foundation Division at the New York-Presbyterian Hospital/Weill Cornell Medical Center.

“Due to patients' varying clinical circumstances, it is important to validate the safety and effectiveness of repeated short-term treatment with eltrombopag in patients with chronic ITP.”

Initiation of the trial follows completion of a phase II study that showed a statistically significant increase in the number of patients achieving a platelet count greater than or equal to 50,000/microliter and decreased bleeding following Promacta doses of >50mg over six weeks.