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Actelion presents Tracleer data at ESC congress

Actelion presents results from a phase III trial investigating Tracleer for pulmonary arterial hypertension at the 2007 European Society of Cardiology congress in Vienna

Swiss-headquartered pharmaceutical company Actelion has presented results from a phase III trial investigating its Tracleer (bosentan) treatment for pulmonary arterial hypertension (PAH) at the 2007 European Society of Cardiology (ESC) congress in Vienna.

Data from the randomised, double blind, placebo-controlled EARLY (Endothelin Antagonist trial in mildly symptomatic PAH patients) study showed that treatment with bosentan in patients with mildly symptomatic WHO functional class II (FCII) PAH significantly delayed clinical degradation by 77 per cent. The compound also reduced the number of patients degrading to WHO functional class III/IV.

Time to clinical worsening was defined by death; hospitalisation and symptomatic progression of PAH. The findings demonstrated significantly lower incidences of worsening of functional class (3.4 per cent, compared with 13.2 per cent) with bosentan compared with a placebo.

The molecule was also shown to reduce pulmonary vascular resistance (PVR) and improved several other haemodynamic measurements. The safety and tolerability profile was consistent with previous placebo-controlled clinical trials in PAH.

Dr Sean Gaine, director of the Pulmonary Vascular Service at the Mater Misericordiae Hospital in Dublin and an EARLY investigator, said: "The EARLY results demonstrated the ability of bosentan to significantly reduce the rate of clinical worsening, and confirms that having identified patients with PAH early, clinicians do not need to wait until patients are in functional class III before intervening."

Dr Jean-Paul Clozel, Actelion's CEO, added: "The EARLY data is being used as a basis for regulatory submissions worldwide. Actelion will continue its clinical research programme to further improve our understanding of PAH disease progression and management."

Actelion submitted the EARLY data to health authorities worldwide for inclusion in the existing product labelling in Q3 2007.

30th September 2008

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