Promacta (Eltrombopag) Platelet Drug Shows Good Results in Trial

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RxTrials Institute Drug Pipeline Alert

June 12, 2007 | Vol. 5 No. 115

Phase III Trial Shows Promising Results With Promacta

GlaxoKline (GSK) announced results from a Phase III study of its

investigational non-peptide oral platelet growth factor, Promacta.

Promacta (eltrombopag olamine) taken in 50- or 75-mg doses once daily

resulted in an 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.

The Phase III trial was an international, randomized, double-blind,

placebo-controlled study that enrolled 114 adults with chronic ITP and

baseline platelet counts of less than 30,000/microliter. Eligible

patients must have failed or stopped responding within three months of

receiving one or more ITP therapies such as corticosteroids,

immunoglobulins and/or splenectomy.

Patients were randomized to either placebo (38 patients) or Promacta

50 mg (76 patients) once daily for six weeks. The Promacta dose could

be increased to 75 mg in patients not responding after an initial

three weeks of treatment. Patients were assessed for platelet count

weekly and up to six weeks following treatment with Promacta.

At the end of the trial, 59 percent of Promacta-treated patients and

16 percent of placebo-treated patients achieved a platelet count of

more than 50,000/microliter. Additionally, there was a lower incidence

of bleeding events during treatment with Promacta compared with

placebo with clinically significant bleeding observed in fewer

Promacta patients (16 percent) than placebo patients (36 percent),

according to the company.