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Home Industry News Actelion concludes dosage study for brain haemorrhage drug

Actelion concludes dosage study for brain haemorrhage drug

19th June 2006

Swiss pharmaceutical company Actelion has announced it has concluded a dosage-finding study for clazosentan in reducing the occurrence of moderate or severe cerebral vasospasm (constriction) following an aneurismal subarachnoid haemorrhage – a type of brain haemorrhage.

Cerebral vasospasm restricts the flow of blood to brain cells and can result in the death of areas of brain tissue. During the trial, entitled CONSCIOUS-1, three doses of claxosentan were used.

The drug was found to be most effective at a dose of 15mg per hour, reducing the risk of cerebral vasospasm by 65 per cent, relative to the placebo. However, this did not necessarily mean that the drug had an overall clinical benefit for patients, as the endpoints for morbidity/mortality, strokes and delayed ischemic neurological deficit (a type of brain damage) were not met.

Isaac Kobrin, head of clinical development at Actelion, remarked: “The information generated from the preliminary analysis of CONSCIOUS-1 demonstrates significance in terms of clazosentan decreasing cerebral vasospasm in a dose-related fashion.”

“A full data analysis and consultation with clinical experts is essential to better understand the apparent disconnect in this study between the significant reduction in cerebral vasospasm and clinical outcome assessed by the endpoint chosen,” he added.

Dr Kobrin concluded: “This full data analysis will determine the future development path.”

Actelion was founded in 1997 and produces two products: Tracleer, a dual endothelin receptor antagonist for use in patients with pulmonary arterial hypertension, and Zavesca, a treatment for type one Gaucher disease (a genetic lipid storage disorder).

The company employs over 1,100 staff.

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