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Mixed news for AstraZeneca's stroke drug Cerovive

Published on 04/05/05 at 01:46pm

AstraZeneca has received a boost from its phase III drug Cerovive, with clinical trial data showing the treatment can reduce the disabling effects of acute ischaemic stroke.

The first analysis of data from its SAINT I trial involving 1,700 patients showed Cerovive (NXY-059) had a statistically significant reduction in disability compared to placebo as measured by the Modified Rankin Scale, the most commonly used scale for assessing disability in stroke patients.

But measured against a second assessment, the National Institute of Health Stroke Scale, a quantitative measurement of neurological impairment, the drug failed to show any benefits over placebo.

AstraZeneca and its development partner, Californian biotech Renovis, said results from two other trials of the drug, SAINT II and CHANT will help clarify the clinical significance of the initial results.

Commenting on the results Dr Tomas Odergren, AstraZeneca's global product director for the drug said: "We are encouraged by these data and what this could mean for stroke patients, as acute ischaemic stroke is a condition for which an effective and well-tolerated treatment is urgently needed."

Cerovive is thought to work by trapping free radicals, chemicals produced in normal cell processes but which are released in huge quantities after a stroke. Researchers believe free radicals are responsible for the serious neurological damage caused by a stroke, and have been searching for some time for agents to block their action.

The World Health Organisation estimates that 15 million people suffer a stroke every year - of whom five million die and another five million are left permanently disabled, creating a large burden of care on relatives and health services.

Stroke is the biggest cause of major disability in the UK and other countries - making research into drugs which can prevent disability and neurological impairment a potentially very lucrative market for the pharmaceutical industry.

The first data to come out of the SAINT I trial is mixed, with AstraZeneca also coy about just how significant the benefits of Cerovive were over placebo.

AstraZeneca has suffered a number of setbacks to major products in the last year, including the rejection of its novel anti-blood clot drug Exanta by the FDA.

The company has introduced a number of changes to how it conducts clinical trials and its regulatory filings, putting its most experienced scientist Dr John Patterson in charge of the new regime.

The company said it plans to file regulatory submissions for Cerovive in the second half of 2006, with a launch likely sometime the following year if approved.

There are two major types of stroke, ischaemic and haemorrhagic: Ischaemic stroke accounts for 85% of strokes worldwide and occurs when a blood clot blocks the flow of blood to a region of the brain. Haemorrhagic stroke involves the rupturing of a blood vessel, leading to bleeding in or on the surface of the brain and can be caused by a number of blood vessel disorders, such as cerebral aneurysms.

The CHANT trial, currently in phase IIb is looking into Cerovive's use in intracerebral haemorrhagic stroke, involving 150 centres in 21 countries.

Renovis' research is based on blocking the action of free radicals, believed to be responsible for a number of conditions involving neurological damage, including neuropathic pain and multiple sclerosis.







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