ATLANTA (Dec. 12, 2005) Amgen (NASDAQ: AMGN), the world's largest biotechnology company, today announced interim results from an open-label study showing that long-term administration (up to 48 weeks) of its investigational therapy AMG 531 was generally well-tolerated and stimulated platelet production in patients with immune thrombocytopenic purpura (ITP). Overall, 85 percent of patients in the study (29 of 34) achieved a platelet response, defined as doubling of the baseline platelet count and at least 50,000 platelets per microliter of blood. The data were presented during an oral presentation at the American Society of Hematology (ASH) 47th Annual Meeting and Exposition. (Abstract #220)
ITP is characterized by an immune system malfunction that recognizes the body's own platelets as foreign and destroys them, potentially resulting in dangerously low platelet counts (less than 30,000 platelets per microliter). Platelets are specialized blood cells that help prevent and stop bleeding by participating in clotting. Normal platelet range for a person without ITP is 150,000 to 400,000 platelets per microliter. AMG 531 is being investigated as a new approach to treat ITP, and other platelet deficiencies, by directly increasing platelet production to outpace platelet destruction by the immune system.
"Traditional therapies for ITP have focused on diminishing platelet destruction by suppressing the immune system, beginning with the use of steroids, followed by surgical removal of the spleen and more intensive immunosuppression. These treatments have potentially serious side effects. For ITP patients who do not respond to these therapies, there are no effective treatment options," said James George, M.D., professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City. "The long-term study results show that AMG 531 administered as an individualized weekly dose resulted in a durable platelet response. If approved, AMG Page: 1 2 3 Related biology news :1
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