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Elan and Wyeth limit Alzheimer's trial

Irish biotech Elan and partner Wyeth have removed the highest dose of potential Alzheimer's therapy bapineuzumab from phase III trials

Irish biotech Elan and partner Wyeth have removed the highest dose of potential Alzheimer's therapy bapineuzumab from phase III trials.

The companies will discontinue trials of 2.0mg/kg of bazineuzumab in two ongoing phase III trials in patients with mild-to-moderate Alzheimer's disease (AD) who do not carry the Apolipoprotein E4 allele. However, trials of 0.5mg/kg and 1.0mg/kg will continue as planned.

The decision to discontinue the higher dose was made following a review of vasogenic edema, an accumulation of water in the brain, by the study's independent Safety Monitoring Committee (SMC).

Two further studies, testing a dose of 0.5mg/kg in patients who are carriers of the Apolipoprotein E4 allele are unaffected by this decision.

Elan president Dr Carlos Paya said: "Our review of the safety data and the feedback from the Safety Monitoring Committee made it clear that continued development of the highest dose was not advisable. The decision to remove the highest dose from development reduces risk to patients and it also helps to reduce risk to the overall development effort."

The global bapineuzumab phase III programme consists of four randomised, double-blind, placebo-controlled studies involving approximately 4,000 patients.

2nd April 2009

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