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GlaxoSmithKline Presents New Data on an Investigational Agent Which Increases Platelet Counts, SB-497115, at the American Society of Hematology Meeting

Posted on: Friday, 3 December 2004, 12:00 CST

PHILADELPHIA, Dec. 3 /PRNewswire-FirstCall/ -- GlaxoSmithKline today announced that data on its investigational platelet producing agent, SB-497115, will be presented at the 2004 annual meeting of the American Society of Hematology (ASH) in San Diego, California. Included in the data from five separate abstracts are the first human clinical data for SB-497115, a thrombopoietin receptor (TpoR) agonist. This agent is being developed for the treatment of thrombocytopenia, a condition characterized by low platelet counts associated with chemotherapy or disease states such as immune thrombocytopenic purpura and chronic liver disease.

The abstracts will be presented on Sunday, December 5th at 6:00 pm and Monday, December 6th at 5:30 pm.

Abstract #2063, Sunday, December 5, 6:00 pm, Halls D and E

Pharmacology and Safety of SB-497115-GR, an Orally Active Small Molecular

Weight TpoR Agonist

(Results of various animal studies)

Teresa Sellers, Timothy Hart, Michael Semanik and Krishna Murthy

Presented by: Connie Erickson-Miller

Abstract #2916, Monday, December 6, 5:30 pm, Halls D and E

An Oral, Non-Peptide, Small Molecule TpoR Agonist Increases Platelet

Counts in Healthy Subjects

(Results of a randomized, single blind, placebo-controlled, parallel

group, Phase I study)

Julian Jenkins, Richard Nicholl, Daphne Williams, Charlotte Baidoo,

Jennifer Phillips, Yanli Deng, Valerie Kitchen, Connie Erickson-Miller

Presented by: Julian Jenkins

Abstract #2910, Monday, December 6, 5:30 pm, Halls D and E

Discovery of SB-497115, a Small-Molecule TpoR Agonist for the Treatment

of Thrombocytopenia

(Results of in vitro cultures of human bone marrow cells; first

demonstration that a small non-peptidyl molecule can trigger receptor

activation responsible for increasing platelet counts)

Juan I. Luengo, Kevin J. Duffy, Anthony N. Shaw, Evelyn Delorme, Kenneth

J. Wiggall, Leslie Giampa, Nannan Liu, Heather Smith, Shin-Shay Tian,

Stephen G. Miller, Richard M. Keenan, Jon Rosen, Susan B. Dillon, Peter

Lamb, Connie Erickson-Miller

Presented by: Juan Luengo

Abstract #2912, Monday, December 6, 5:30 pm, Halls D and E

Biological Activity and Selectivity for TpoR of the Orally Bioavailable,

Small Molecule, SB-497115

(Results of in vitro bone marrow assays)

Connie Erickson-Miller, Evelyn Delorme, Leslie Giampa, Christopher

Hopson, Elizabeth Valoret, Shin-Shay Tian, Stephen G. Miller, Richard M.

Keenan, Jon Rosen, Susan B. Dillon, Kevin J. Duffy, Peter Lamb, Juan

Luengo

Presented by: Connie Erickson-Miller

Abstract #2909, Monday, December 6, 5:30 pm, Halls D and E

Species Specificity and Receptor Domain Interaction of a Small Molecule

TpoR Agonist

(Results of in vitro experiments on cell signaling mechanisms for TpoR

activity in increasing platelet counts)

Connie Erickson-Miller, Evelyn Delorme, Maya Iskandar, Leslie Giampa,

Christopher Hopson, Juan Luengo, Kevin Duffy, Susan Dillon, Jon Rosen,

Stephen Miller, Peter Lamb, Shin-Shay Tian

Presented by: Connie Erickson-Miller

About SB-497115

SB-497115 is an orally active, selective, small molecule, non-peptidyl TpoR agonist. SB-497115 is being developed for the treatment of thrombocytopenia associated with chemotherapy or disease states such as immune thrombocytopenic purpura and chronic liver disease.

SB-497115 is the first non-peptide small molecule TpoR agonist to demonstrate activity in human bone marrow in vitro assays and pharmacological activity in humans. Data from a Phase I study in healthy volunteers (ASH Abstract #2916) show that SB-497115 increased platelet counts in a dose- dependent fashion when administered orally.

Phase II studies are being initiated to evaluate SB-497115 in patients with chemotherapy induced thrombocytopenia and in thrombocytopenia associated with various disease states.

To find out more about ongoing clinical trials with SB-497115 call 1-800-563-7137. Information about trials will also be available at http://www.clinicaltrials.gov/, a website maintained in the U.S. by the FDA.

About Thrombocytopenia

Thrombocytopenia is a disorder in which there are an abnormally low number of platelets in the circulating blood. Platelets are cells in the blood that help blood to clot. Thrombocytopenia could lead to complications ranging from minor bleeding to severe hemorrhages and may impact the lifestyle of individuals with this condition.

Thrombocytopenia is a frequent finding in several medical disorders such as aplastic anemia, myelodysplasia, immune thrombocytopenic purpura, chronic liver disease, septicemia, and disseminated intravascular coagulation. Clinically significant thrombocytopenia can also occur following exposure to myelosuppressive or myeloablative chemotherapy or radioimmunotherapy. In some cases, thrombocytopenia is a chronic (long-lasting) condition that persists for years, but in other cases, it develops suddenly and dramatically.

About GlaxoSmithKline

GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline at http://www.gsk.com/.

GlaxoSmithKline

CONTACT: US Media Inquiries: Danielle Halstrom, GlaxoSmithKline,+1-215-751-3981

Web site: http://www.clinicaltrials.gov/

Web site: http://www.gsk.com/

Source: PRNewswire-FirstCall

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