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AstraZeneca gets thumbs up for Cerovive trial

Date published: 14/12/2005

AstraZeneca has received clearance to continue its trial of the stroke drug Cerovive. The go ahead was given following an interim safety review undertaken by the US Independent Data and Safety Monitoring Board (IDMB) and the trial steering committee.

AstraZeneca is the exclusive licensee of NXY-059/Cerovive from US firm Renovis and the Phase III SAINT II trial will continue as planned. The trial will test positive findings that found a statistically significant reduction in the primary outcome of disability after an acute ischemic stroke.

Dr Corey Goodman, president and chief executive officer of Renovis said: "The IDMB's recommendation to continue SAINT II as planned following their review of safety data from the trial is welcome news.

"We interpret this recommendation as further support that NXY-059/Cerovive is well tolerated in acute ischemic stroke patients. This is an important characteristic of NXY-059/Cerovive in a population of patients previously found to be highly vulnerable to adverse effects of many other drug candidates tested to date."

The SAINT II trial will be conducted in around 350 centres in 30 countries.

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