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AstraZeneca completes enrolment in phase III trial of Cerovive
Germany | Wednesday, December 8, 2004, 08:00 Hrs  [IST]

AstraZeneca has completed the enrolment of patients in SAINT I, one of two phase III trials (SAINT I and II) being conducted to determine the effect of Cerovive (NXY-059) on disability and neurological recovery in acute ischaemic stroke patients, the company announced here.

Enrolment is continuing in the parallel phase III trial (SAINT II) and in a phase IIb trial (CHANT - Cerebral Haemorrhage And NXY-059 Treatment). SAINT I and II are two multinational, multi-centre, double-blind, randomized, placebo-controlled parallel-group studies designed to determine the effect of Cerovive (NXY-059) on disability and neurological recovery in acute ischaemic stroke patients. CHANT is a double-blind, randomized, placebo-controlled, parallel-group, multi-centre study to assess the safety and tolerability of 72 hours intravenous infusion of Cerovive (NXY-059) in adult patients with acute intracerebral haemorrhage.

The SAINT trials for Cerovive (NXY-059) are being conducted worldwide and are planned to enrol more than 3,000 subjects in approximately 400 centres across approximately 40 countries (Europe, Asia, Australia, New Zealand, South Africa, United States, Canada and Latin America) to evaluate the effect of the compound in acute ischaemic stroke patients. The safety of patients included in the trials is being continually evaluated. The CHANT trial will involve at least 150 centres in 21 countries.

Cerovive (NXY-059), a neuroprotectant with free-radical trapping properties, is a drug under development by AstraZeneca and licensed from Renovis, Inc.

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