Pharming Group NV and Salix Pharmaceuticals Ltd. announced that the first patient was treated in their Phase 2 clinical study of Ruconest, (C1 Esterase Inhibitor Recombinant) 50 IU/kg, for prophylaxis in patients with hereditary angioedema (HAE). HAE patients deficient in C1 inhibitor and with a history of at least four attacks per month are being enrolled in the randomized, double-blind study, in which 30 patients will receive Ruconest either once or twice weekly, or placebo in each of 3 treatment periods. With the crossover design, all patients will receive each of the dosing regimens.

The study will evaluate the safety and efficacy of Ruconest when used for prophylaxis of angioedema attacks in patients with HAE. The study will be conducted at sites in Canada, Europe, Israel, and the United States. The trial is being coordinated by principal investigators, Dr. Marco Cicardi, Professor at the University of Milan, and Dr. Marc Riedl, Associate Professor and Clinical Director of the US HAEA Angioedema Center at the University of California, San Diego.