ACTELION REPORTS POSITIVE DATA ON TRACLEER IN PVR

Actelion announced the initial results from the Phase III, double-blind, placebo-controlled, multicenter study BENEFiT. The study met its primary objective, as treatment with Tracleer was associated with a significant reduction in pulmonary vascular resistance (PVR).

In this double-blind, 157-patient study in a patient population suffering from this form of pulmonary hypertension, the six-minute walk test remained stable over the four months of blinded evaluation in both treatment groups. Patients on Tracleer (bosentan) showed a significant improvement in breathlessness with exercise.

Initial results also indicate that treatment with bosentan was associated with a significant decrease in NT-proBNP, an important biomarker of disease severity. In this study, Tracleer's safety and tolerability profile was consistent with that observed in previous placebo-controlled clinical trials in pulmonary arterial hypertension (PAH).

"For patients with inoperable [chronic thromboembolic pulmonary hypertension], there are currently no approved therapies available," Isaac Kobrin, and head of development at Actelion, said. "Now, our dual endothelin receptor antagonist bosentan has shown in this patient population significant improvements in hemodynamic parameters that suggest positive patient benefits, as demonstrated by the significant improvements in breathlessness during exercise."

Chronic thromboembolic pulmonary hypertension is caused by obstruction of the pulmonary arteries by organized persistent thrombi leading to increased PVR, progressive pulmonary hypertension and ultimately right-heart failure.

Tracleer is the first oral dual endothelin receptor antagonist approved for the treatment of PAH in the U.S., the European Union and other markets worldwide, according to Actelion.