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Published on 12/12/2005 in the Prospect News Biotech Daily.

Amgen AMG 531 follow-up shows platelet increases for immune thrombocytopenic purpura

By Jennifer Chiou

New York, Dec. 12 - Amgen announced interim results for AMG 531 that indicate long-term application stimulated platelet production in patients with immune thrombocytopenic purpura (ITP).

The company said 85% of patients in the 34-person study achieved a platelet response, defined as doubling of the baseline platelet count and at least 50,000 platelets per microliter of blood.

"The long-term study results show that AMG 531 administered as an individualized weekly dose resulted in a durable platelet response," said James George, professor of medicine at the University of Oklahoma Health Sciences Center, in a news release.

"If approved, AMG 531 may provide an important therapeutic option for ITP patients, potentially enabling patients to taper off long-term steroid therapy."

Amgen presented the data at the American Society of Hematology 47th Annual Meeting and Exposition.

"It is exciting that most patients in this study achieved platelet counts of greater than 50,000 per microliter, despite how refractory they were, from a starting count of approximately 18,000," James B. Bussel, professor of pediatrics and medicine at the Weill Cornell Medical Center, added in the release.

"This is important because it suggests that AMG 531 may stimulate platelet production faster than the immune system can destroy them, enabling patients to sustain a satisfactory platelet count with ongoing AMG 531 treatment."

AMG 531, an investigational protein called a peptibody, works similarly to thrombopoietin, a natural protein in the body.

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, according to the release.

The Atlanta-based biotechnology company is focused on cancer, kidney disease, rheumatoid arthritis and other illnesses.


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