Alexion Completes Enrollment in AEGIS Registration Study of Soliris(R) (eculizumab) in Patients with PN...( CHESHIRE Conn. March 20 /- Alexio...),Health

CHESHIRE, Conn., March 20 /PRNewswire-FirstCall/ -- Alexion Pharmaceuticals, Inc. (the "Company") (Nasdaq: ALXN) today announced that it has completed enrolling patients in its previously announced AEGIS study, a single registration study to evaluate the safety, efficacy, and pharmacology of Soliris(R) (eculizumab) as a treatment for Japanese patients with paroxysmal nocturnal hemoglobinuria (PNH). The open-label study, which was authorized by Japan's Pharmaceutical and Medical Device Administration (PMDA), over-enrolled a total of 29 patients. The patients will be treated with Soliris at clinical sites throughout Japan for 12 weeks.

PNH is a rare, acquired genetic blood disorder defined by hemolysis, in which patients' red blood cells are destroyed by complement, a component of the body's immune system. The primary efficacy endpoint of the study is reduction of hemolysis from baseline. The study will also measure the effect of Soliris on other clinical manifestations of PNH, including blood transfusion requirements, thromboses (blood clots), and kidney function. Important measures of patients' overall quality of life, including fatigue, will also be assessed.

The inclusion and exclusion criteria for the AEGIS study are similar to those used in the SHEPHERD study, one of Alexion's previous Phase 3 studies of Soliris as a treatment for PNH. SHEPHERD examined the safety and efficacy of eculizumab in a broad and diverse population of patients with PNH, including patients with minimal transfusion requirements and/or evidence of thrombocytopenia. (1) Based on the SHEPHERD study and the companion TRIUMPH Phase 3 study, (2) Soliris was approved in 2007 as the first treatment for patients with PNH by the U.S. Food and Drug Administr
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