Actelion's Pivlaz enters Ph III assessment

Swiss biotechnology firm Actelion has begun a Phase III trial of its endothelin receptor antagonist Pivlaz (clazosentan). The drug, which is designed to reduce the risk of vasospasm-related morbidity and all-cause mortality following aneurysmal subarachnoid hemorrhage, will be assessed in terms of both its safety and therapeutic efficacy.

An earlier study, known as CONSCIOUS-1, showed that the drug significantly reduced the occurrence of moderate-to-severe cerebral vasospasm, the contraction of blood vessels in the brain, by around 65%. The new trial, CONSCIOUS-2, will seek to confirm these findings through various measures including: an assessment of neurological deterioration; the occurrence of new brain infarcts; and the use of rescue therapy.

Actelion added that initiation of Phase III trials of Pivlaz in this indication triggers a 15.0 million Swiss franc ($13.4 million) payment to the shareholders of the drug's original developer, Axovan, which it acquired in 2003 (Marketletters passim).