is expanding the development of its blood infection drug CytoFab.
After consultation with the Food and Drug Administration and regulators in the European Union, the pharmaceuticals giant has decided to add a 480-patient trial to support a larger study. The larger study alone wouldn't have been sufficient for approval, the company says.
The additional study is slated to begin in the second half of 2007.
"Our goal is to optimize the chances of showing a statistically and clinically meaningful result with CytoFab, in a single, global phase III study, while ensuring an acceptable time to market," said John Rex, AstraZeneca's medical director for infection. "We believe that this development plan will give us the best chance of successful registration for this exciting treatment."