Actelion initiates phase III Pivlaz study

Actelion has announced the start of phase III clinical trials of Pivlaz (clazosentan) to show the prevention of vasospasm-related morbidity and mortality from all causes following an aneurysmal subarachnoid haemmorage.

The Conscious-2 programme will assess the efficacy and safety of the compound with earlier trials showing the compound to be associated with up to 65 per cent reduction in vasospasm.

Approximately 765 patients from over 100 centres worldwide will be involved in the study, with individuals receiving either 5 mg/h of Pivlaz or placebo, with study results expected from the second half of 2009.

Pivlaz is an intravenous endothelin receptor antagonist with the ability to cross the blood-brain barrier. It prevents the vasoconstriction and inflammation known to induce vasospasm by blocking endothelin.

Neal Kassell, distinguished professor and co-chairman of the Department of Neurosurgery at the University of Virginia, said: “Vasospasm is a major problem in patients with aneurysmal subarachnoid haemorrhage.

“Vasospasm is both unpredictable and the leading treatable cause of disability and death.”

He added that the Conscious-2 trial is designed to show the reduction in the incidence of vasospasm which will result in a measurable clinical benefit for patients.

In October 2006, Actelion reported results from the Conscious-1 study, showing that the 15 mg/hour dose of clazosentan achieved the most significant effect in preventing vasospasm.