AstraZeneca to undertake extra Ph II CytoFab study following EMEA/FDA discussions

Anglo-Swedish drug major AstraZeneca says that it will carry out an additional Phase II clinical trial of its developmental sepsis treatment CytoFab (polyclonal ovine anti-tumor necrosis factor antibody fragments). The agent, which is being developed under license from UK-based drugmaker Protherics, is designed to address severe sepsis caused by toxins resulting from systemic bacterial infection.

Study to bolster safety and efficacy data

The announcement follows discussions with both the US Food and Drug Administration and the European Medicines Agency (EMEA), which confirmed that regulators had requested an additional Phase II assessment of the product, prior to sanctioning the crucial Phase III trial program. The company said that the new Phase II study would provide further evidence of the drug's safety and efficacy, as well as allowing it to establish the most appropriate dose for any subsequent Phase III trial.