Wyeth stops trial of bapineuzumab in high doses

Wyeth has asserted the data from two of its phase III studies of bapineuzumab shows it not to be safe when given in the highest dose.

As a result, it has decided to stop trials of 2.0 mg/kg measurements, which was the greatest of the three quantities being examined.

The drug is being tested for use in patients with moderate Alzherimer’s disease who do not carry Apolipoprotein E4, which is known to be a genetic risk of the condition.

No changes are being made to the other two ongoing studies because of the recent decision.

Dr Carlos Pava, president of Elan ? a company working with Wyeth on the project, explained it was clear from reviewing the data and feedback from the safety monitoring committee that the drug in its largest quantity was not suitable.

“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,” Dr Pava concluded.

Earlier this week, Wyeth announced it had submitted a Biologic License Application to the Food and Drug Administration for its 13-valent conjugate vaccine.