GSK reports strong Ph II data on Promacta: first ever oral drug for treatment of ITP

UK drug major GalxoSmithKline has reported additional data on its Promacta (eltrombopag) at the American Society of Hematology meeting, held in Orlando, Florida. Results from this six-week Phase II study of the oral platelet growth factor in the auto-immune disorder, chronic idiopathic thrombocytopenia purpura (ITP), show a decrease in bleeding that parallels the increase in platelets following treatment across the dose range.

According to James Bussell, Director of the Platelet Disorders Center at New York's Presbyterian Hospital and Weill Cornell Medical Center, who presented the data, the incidence of bleeding during treatment and in a follow-up period, was halved by eltrombopag at the 75mg dose. Efficacy data showing a significant increase in platelets at the 50mg and 75mg doses were presented previously in June 2006.

The Phase II study had been truncated at 117 patients before the planned recruitment of 270 had finished because the majority of subjects treated with the two study doses (70% and 80%) achieved the trial's primary endpoint of increasing platelets to a level above 50,000/mL (p<0.001), Dr Bussel said, adding that other patients may need a higher dose and these will be investigated in further studies.