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Phase III data looks promising for GSK's eltrombopag
 
 
  11/06/2007
www.pharmatimes.com
 
GlaxoSmithKline has presented positive data from a late-stage study of its new platelet-boosting treatment Revolade, one of the drugs in the firm's pipeline that analysts believe can be a blockbuster.
 
Results from a pivotal international Phase III study, which were presented at the European Haematology Association congress in Vienna, showed that Revolade (eltrombopag), at 50-75mg once daily, resulted in a statistically significant increase in platelet counts and also reduced bleeding in adult patients with chronic idiopathic thrombocytopenia purpura.
 
ITP is a low platelet count disorder that leaves sufferers at risk of spontaneous bruising, mucosal bleeding and, in severe cases, intracranial haemorrhage. There are estimated to be 50,000-100,000 people diagnosed with chronic ITP in the USA alone and the predicted five-year mortality rates for ITP patients with persistent low platelet counts range from 2.2% for patients younger than 40 years of age, to 47.8% for those older than 60.
 
Patients on the trial were randomised to either placebo (38 patients) or eltrombopag 50mg (76 patients) once daily for six weeks though the Revolade dose could be increased to 75mg in patients not responding after an initial three weeks of treatment. At the end of the trial, 59% of eltrombopag-treated patients and 16% on placebo treated patients achieved a platelet count of more than 50,000/microlitre. Importantly, said GSK, there was a significantly lower incidence of bleeding events during treatment with Revolade compared to placebo.
 
Drew Provan of the Department of Haematology at the Royal London Hospital, UK, and an investigator on the trial said that options are particularly limited for those patients who fail to respond to primary treatment altogether and those who initially respond and then fail. Now, he added, "these trial results demonstrate that eltrombopag may represent the potential for a new oral therapy to reduce the number of bleeding episodes in ITP patients."
 
Revolade, which will be marketed as Promacta in the USA if approved, was discovered as a result of research collaboration between GSK and Ligand Pharmaceuticals, and several trials of the compound are ongoing.
 
Phase III trials to start on GSK's eltrombopag
 
16/04/2007
www.pharmatimes.com
 
GlaxoSmithKline is initiating Phase III trials of its investigational drug, eltrombopag, giving fresh hope to patients suffering from idiopathic thrombocytopenic purpura (ITP), a low platelet count disorder that leaves sufferers at risk of spontaneous bruising, mucosal bleeding and, in severe cases, intracranial hemorrhage.
 
The trial will investigate the drug's safety and efficacy in a double-blind, randomised, placebo-controlled, parallel group of 50 patients with previously-treated ITP. Sites for this multicentre study will involve 33 countries, including the US, UK, Canada and France.
 
Paolo Paoletti, managing director and senior vice president of GlaxoSmithKline's Oncology Medicine Development Centre, said: "Data to date demonstrates that eltrombopag may be effective in increasing platelet counts in patients with chronic ITP and this trial will help us to further evaluate its potential."
 
Ph II results promising
 
Top-line results of the Phase II trial in ITP were reported in December 2005. These showed that eltrombopag, at doses of 75mg and 50mg, increased platelet count from a baseline of less than 30,000/L to at least 50,000/L after 42 days of dosing.
 
ITP is thought to affect between 50 and 100 people per million in the US and Europe. Although the disease can be managed chronically, as many as 5% of patients die within ten years of diagnosis. The condition can also impede a variety of medical treatments, in particular chemotherapy, and interferon therapy for patients with hepatitis C infection, by preventing patients from receiving their full dose.
 
GSK drug gets hep C patients onto therapy
 
30/10/2006
www.pharmatimes.com
 
GlaxoSmithKline's platelet-boosting drug Promacta can be an effective treatment for patients with hepatitis C whose low blood platelet counts mean that they cannot be treated with interferon, the standard therapy for the infection.
 
The results of a Phase II study involving 74 patients with chronic hepatitis C revealed that Promacta (eltrombopag) was able to boost platelet levels in more than 95% of patients treated to the extent that therapy with pegylated interferon alpha could be started.
 
Low platelet counts - or thrombocytopenia - is a common symptoms in patients with chronic liver disease such as HCV. Because treatment with interferon can also reduce platelet levels, patients with thrombocytopenia can be excluded from starting or being continued on treatment.
 
Paolo Paoletti, senior vice president of oncology drug development at GSK, said: "As we move into Phase III trials for eltrombopag in a variety of conditions where thrombocytopenia is a complicating factor, these data represent a significant milestone for GSK in supportive care." Phase III trials in this indication are due to start next year.
 
A Phase II trial of the drug in patients with thrombocytopenia caused by chemotherapy failed in its primary endpoint, although this was due to the chemotherapy drug in the study not significantly impacting platelet production in the first place, which was an unexpected result.
 
Progress in first indication
 
Eltrombopag is currently in Phase III trials for the haematological disorder idiopathic thrombocytopenic purpura, and GSK is hoping to file for marketing approval of the drug for short-term treatment of ITP in 2007. It had earlier said it wanted to file later this year, but now says it needs discussion with regulatory authorities "to determine whether these data will be sufficient to file for approval next year."
 
A phase III clinical programme is underway to assess the use of Promacta for the long-term treatment of ITP, with filings for this indication anticipated in 2008.
 
GSK's eltrombopag in ITP showcased at ASH
 
13/12/2006
www.pharmatimes.com
 
Eltrombopag, GSK's new thrombocytopenia treatment, has performed exceptionally well in a six-week Phase II trial of patients with the autoimmune disease, chronic idiopathic thrombocytopenia purpura, according to lead investigator Dr James Bussell of New York's Presbyterian Hospital's Weill Cornell Medical Center.
 
Data presented at the American Society of Hematology meeting in Orlando showed the study had already reached its primary endpoint by the time only a third of the planned 270 patients had been treated.
 
Dr Bussell told an ASH press conference: "The trial was stopped at the interim analysis of the first 90 patients because results were significant at the 0.001 level for both the 50mg and 75mg doses." More than 70% of patients achieved a platelet count greater than 50,000 with a 50mg dose while this rose to 80% with a 75mg dose, he said. "At both these doses there was a dramatic decrease in bleeding in line with platelet increases." The incidence of side effects were similar to those seen with placebo.
 
Eltrombopag, to be called Promacta in the USA, is the first orally administered, once-daily treatment for thrombocytopenia and is set to be a "major advance in the management of ITP," said Dr Bussell. It is thought to work by stimulating thrombopoietin receptors on megakaryocytes in the bone marrow to increase production of platelets. Previous therapies have focused on inhibiting destruction of platelets by suppressing the immune system or surgically removing the spleen.
 
Six-month Phase III trial has already begun
GSK announced last week that the product has started a six-month Phase III study and, although ITP is a fairly rare condition affecting around one person in 10,000, thrombocytopenia also occurs in 5%-10% of all patients admitted to hospital as a consequence of chemotherapy and secondary hepatitis C infection.
 
The company says it expects to submit data in at least one indication to the US and European regulatory authorities in 2007-8.
 
 
 
 
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