Alexion completes patient treatment in phase 3 trial of eculizumab

By Angela McDaniels

Seattle, Jan. 4 - Alexion Pharmaceuticals Inc. said it has completed treatment of the final patient in the pivotal phase 3 efficacy trial of eculizumab in patients with paroxysmal nocturnal hemoglobinuria (PNH), a chronic blood disorder characterized by destruction of red blood cells by the immune system.

Eighty-five patients in the United States, Canada, Europe and Australia were randomized to receive either eculizumab or placebo for six months. Primary endpoints include hemoglobin stabilization and blood transfusion requirements.

The company expects to announce top-line clinical results later in the first quarter and to submit applications later this year to both U.S. and European regulatory authorities for approval to market eculizumab for use in PNH patients.

Eculizumab is a monoclonal antibody drug that selectively blocks terminal complement, a part of the immune system that is implicated in PNH red blood cell destruction. There currently is no drug available specifically for treatment of PNH, the company said.

Alexion is based in Cheshire, Conn., and develops therapeutic products aimed at treating severe disease states, including hematologic and cardiovascular disorders, autoimmune diseases and cancer.

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