Trial Data Showed Promacta(TM) Decreased Bleeding Episodes And Improved Platelet Counts In Patients With Idiopathic Thrombocytopenic Purpura

GlaxoSmithKline (GSK) today
announced additional results from an international Phase II short-term,
six- week study of its investigational non-peptide oral platelet growth
factor, Promacta(TM) (eltrombopag). Analysis of data from this study showed
that Promacta at 50mg or 75mg resulted in a positive trend in decrease in
bleeding incidence (all grades) in adult patients with chronic idiopathic
thrombocytopenic purpura (ITP), an autoimmune condition which results in
low blood platelet counts and bleeding from the small blood vessels. These
data were presented today at the 48th Annual American Society of Hematology
(ASH) meeting in Orlando, Florida.(1)



The primary efficacy data from this study of (a statistically
significant increase in platelet counts at 50mg and 75mg doses) were
previously presented at the European Society of Hematology in June 2006.



"Current treatments for ITP, such as steroids or the removal of the
spleen, have limitations and side effects," says James B. Bussel, MD,
director of the Platelet Disorders Center, Children's Blood Foundation
Division at the New York-Presbyterian Hospital/Weill Cornell Medical Center
and principal investigator for this trial. "Bleeding events caused by ITP,
whether categorized as moderate or severe, are of great concern to patients
and physicians. These study results indicate there is a potential new oral
treatment that can reduce bleeding episodes."



The Phase II trial was an international randomized, double-blind,
placebo- controlled study that enrolled 117 adult patients with chronic ITP
with baseline platelet counts of








"We are very excited by these results for Promacta, which show great
promise for chronic ITP patients who failed different lines of treatment,"
said Paolo Paoletti, MD, Senior Vice President, Oncology Medicine
Development Center, GSK. "Clinical trials for Promacta are ongoing, not
only in ITP but also other conditions where thrombocytopenia is a clinical
issue -- for example liver disease and patients receiving chemotherapy. Our
robust clinical trial program reflects our continued commitment in
delivering novel treatments to address unmet medical needs."



About Promacta



Promacta is an investigational non-peptide thrombopoietin receptor
agonist that has been shown in pre-clinical research and clinical trials to
stimulate the proliferation and differentiation of megakaryocytes, the bone
marrow cells that give rise to blood platelets, and thus may be considered
a platelet growth factor. Promacta is administered orally as a tablet and
may have less potential than large protein molecules for causing an immune
system reaction. The safety profile will be further examined in the ongoing
clinical trials program. Promacta was discovered as a result of a research
collaboration between GlaxoSmithKline and Ligand Pharmaceuticals. It is
being developed by GlaxoSmithKline. Promacta is an investigational compound
that has not received regulatory approval in any market for any indication
at this time.



About Idiopathic Thrombocytopenia Purpura



ITP is an autoimmune bleeding disorder characterized by increased
platelet clearance and/or inadequate platelet production, creating
thrombocytopenia (low platelet count). Its cause is currently unknown.
Primary ITP is estimated to affect 50 to 100 new persons per million per
year in the United States and Europe.(3) People with ITP often bleed from
small blood vessels underneath the skin causing bruises, nosebleeds,
bleeding from the gums during dental work, or other bleeding that is
difficult to stop. Bleeding in the brain or gastrointestinal (GI) tract is
rare but can be life threatening if it occurs.(4) Some patients with ITP
are asymptomatic or have mild bruising while others develop mucosal
bleeding that can become severe.(5) ITP is associated with a 5% ten year
fatality rate primarily from intracranial hemorrhage.(6)



A normal blood platelet count is greater than or equal to
150,000/microliter and less than or equal to 400,000/microliter.(7) A
reduction in platelet count (to a level Buy Retin-A Online no Prescription