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Elan and Wyeth Plan to Amend Bapineuzumab Phase 3 Protocols

06 Apr 2009

Two pharmaceutical companies have announced that they are changing the phase III studies using the drug bapineuzumab in Alzheimer''s patients.

Elan and Wyeth are to stop using 2.0 mg/kg - the highest of the three dose regimens - during the trials of patients who do not carry the Apolipoprotein E4 (ApoE4) allele.

It follows advice from the study''s safety monitoring committee (SMC) after its review of vasogenic edema in the programme.

The body concluded the stronger dose could prove problematic but said it currently had no concerns over the 0.5 and 1.0 mg/kg cohorts.

Elan president Carlos Paya explained the company is committed to continuing its research into Alzheimer''s disease.

"Our review of the safety data and the feedback from the SMC made it clear that continued development of the highest dose was not advisable," he explained.

Mr Paya added the decision to remove the higher dose would reduce any risk to the study''s 4,000 patients.

Meanwhile, Novartis has received the European Commission''s approval to market its Ixario drug, which is used as a vaccine for the prevention of Japanese Encephalitis.