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14.02.2006 – 14:23

GlaxoSmithKline GmbH & Co. KG

GlaxoSmithKline Announces Commencement of Eltrombopag Phase III Worldwide Clinical Trial in Adults With Previously-Treated Idiopathic Thrombocytopenic Purpura

London, England and Philadelphia, Pennsylvania (ots/PRNewswire)

GlaxoSmithKline plc (GSK) announced today the commencement of 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). ITP is a disorder characterized by
low platelet counts leaving patients at risk of episodes of
spontaneous bruising, mucosal bleeding, and in severe cases
intracranial hemorrhage.
The multicenter Phase III study, has a double-blind, randomized,
placebo-controlled, parallel group design. Subjects will be
randomized to receive eltrombopag or placebo once daily for six
weeks. The study population will comprise adults with ITP, diagnosed
at least six months prior to screening, who have platelet counts
<30,000/microL and who have not responded to previous treatment or
have relapsed within three months of previous treatment. Those who
achieve a platelet count of greater than or  equal to 50,000/microL
after 42 days of dosing will be considered treatment  responders.
Safety and quality of life outcomes also will be assessed.
"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," said Paolo
Paoletti, MD, Senior Vice President, Oncology Medicine Development
Centre, GSK. "The initiation of this trial also represents a
significant milestone for GSK oncology and supportive care and
underscores our continued commitment to delivering novel treatments
to patients with significant unmet medical need."
Trial sites are in 33 countries, including Italy, Denmark, Poland,
France, Germany, United Kingdom, Spain, Switzerland, Russia,
Netherlands, Hong Kong, Pakistan, Mexico, Australia, United States,
and Canada.
Top line results of the Phase II trial in ITP - which had a
similar design as the Phase III trial, but tested various dosing
levels - were reported in December, 2005, in conjunction with the
47th Annual Meeting of the American Society of Hematology in Atlanta.
The study of 97 patients found that eltrombopag, at doses of 75 mg
and 50 mg, compared with placebo (p<0.001), 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. The 30 mg dose
showed limited change from baseline. Further, there were no safety or
tolerability events that would preclude advancement to Phase III
studies.
About Eltrombopag
Eltrombopag is an investigational small-molecule thrombopoietin
receptor agonist that is thought to stimulate the proliferation and
differentiation of megakaryocytes, the bone marrow cells that give
rise to blood platelets, and thus is considered a platelet growth
factor. Because it is a small molecule, the drug is administered
orally as a tablet and has less potential than large protein
molecules for causing an immune system reaction. Eltrombopag was
discovered as a result of a research collaboration between
GlaxoSmithKline and Ligand Pharmaceuticals. It is being developed by
GlaxoSmithKline.
About Thrombocytopenia
A reduction in platelet count is the defining characteristic of
any type of thrombocytopenia and diagnosis can be confirmed following
a routine blood test. Idiopathic thrombocytopenic purpura is an
autoimmune disorder that is marked by platelet destruction and/or
inadequate platelet production. The onset of symptoms is sometimes
unpredictable and patients suffering from thrombocytopenia may be
asymptomatic. Thrombocytopenia also can occur as a consequence of
chemotherapy treatment, interferon treatment, or chronic liver
disease. The prevalence of the disease is not well-established, as
there are very few published epidemiologic studies of this disease in
the United States. Two epidemiologic studies of incident ITP in
Europe found that incidence ranged from 16 to 23 per 1 million
persons per year. An internal study of a managed-care population in
the United States estimated the prevalence of chronic ITP at around
77,000 cases.
Thrombocytopenia can impede a variety of medical treatments. It
can prevent cancer patients from receiving their full dose of
chemotherapy, prevent patients with hepatitis C infection from
receiving interferon therapy or lead to dose reductions or
discontinuation, and it can prevent or complicate procedures
(surgical, dental, etc.) in patients with chronic liver disease and
ITP.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies. GlaxoSmithKline is committed
to improving the quality of human life by enabling people to do more,
feel better and live longer. For company information visit
www.gsk.com.
Information about trial enrollment can be obtained by visiting
www.itpstudy.com or www.clinicaltrials.gov
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the US Private Securities
Litigation Reform Act of 1995, the company cautions investors that
any forward-looking statements or projections made by the company,
including those made in this Announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from
those projected. Factors that may affect the Group's operations are
described under 'Risk Factors' in the 'Operating and Financial Review
and Prospects' in the company's Annual Report 2004.

Contact:

Enquiries: UK Media enquiries: Philip Thomson +44-(020)-8047-5502,
David Mawdsley +44-(020)-8047-5502, Chris Hunter-Ward
+44-(020)-8047-5502, Alice Hunt +44-(020)-8047-5502; US Media
enquiries: Nancy Pekarek +1-(215)-751-7709, Mary Anne Rhyne
+1-(919)-483-2839, Patricia Seif +1-(215)-751-7709; European
Analyst/Investor enquiries: Duncan Learmouth +44-(020)-8047-5540,
Anita Kidgell +44-(020)-8047-5542, Jen Hill +44-(020)-8047-5543; US
Analyst/ Investor enquiries: Frank Murdolo +1-(215)-751-7002, Tom
Curry +1-(215)-751-5419

Original content of: GlaxoSmithKline GmbH & Co. KG, transmitted by news aktuell