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Soliris(R) Reduced Measures of Thrombosis and Inflammation, and Decreased Indicators of Pulmonary Hypertension, in Studies of Patients with PNH
Date:12/9/2008

ght patients with PNH, only one of which had been previously diagnosed with a blood clot.

Results showed that prior to treatment with Soliris, patients with PNH exhibited a hypercoagulable state as indicated by elevated levels of key inflammatory and pro-thrombotic measures. Soliris treatment was associated with statistically significant decreases in key blood measures, including LDH levels (p=0.0001), D-dimers (p=0.0057), thrombin-antithrombin complex or TAT (0.01), interleukin 6 or Il-6 (p=0.04), and tissue factor microparticles or TFMP (0.02) during the four-week induction phase of treatment. All decreases in D-dimers, TAT, Il-6, TFMP, and LDH were sustained in the maintenance phase of treatment.

The authors concluded that the study patients, most of whom did not have clinical evidence of thrombosis and were also not previously transfused, exhibited a hypercoagulable state. In these patients, Soliris treatment was observed to result in a decrease in measures of thrombin generation and inflammation. These changes appeared to be independent of the observed reduction in hemolysis.

"This data deepens our understanding of the complex interactions in the blood that result in dangerous inflammation and blood clots in patients with PNH," said Dr. Weitz. "It also suggests that many patients with PNH, even without a clinical thrombosis, exhibit a high risk for blood clotting, and provides hope for patients and physicians, since thrombosis is the leading cause of premature death in PNH and the most feared complication of the disease."

Pulmonary Hypertension

Research titled "Eculizumab Reduces Pulmonary Hypertension through Inhibition of Hemolysis-Associated Nitric Oxide Consumption in Patients with Paroxysmal Nocturnal Hemoglobinuria" was presented in an oral session yesterday at the ASH annual meeting by Anita Hill, M.D., of the Department of Haematology, Bradford Royal Infirmary
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SOURCE Alexion Pharmaceuticals, Inc.
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