ASTRAZENECA TO CONDUCT AN ADDITIONAL CYTOFAB TRIAL

AstraZeneca has announced its intention to expand the development plan for CytoFab, a treatment for severe sepsis, with the addition of a 480-patient Phase II study.

The company has recently completed consultations with regulators in the U.S. and EU. These consultations confirmed that a single Phase III study could be sufficient for regulatory approval. Furthermore, to meet the regulatory needs of both agencies, it is required that AstraZeneca implement a Phase II study program to support the single global Phase III study.

Data from Phase II will be used to more accurately estimate the number of patients required, and confirm the appropriate dose, for the Phase III study, as well to provide further supporting efficacy and safety data. This may enable a shorter timetable for the Phase III program than originally anticipated. The Phase II program will start in the second half of 2007 and is expected to last up to 21 months. It will be immediately followed by the Phase III study in the U.S., the EU and Japan. Under the terms of a licensing agreement, AstraZeneca is responsible for conducting and funding the global development of CytoFab, and Protherics is responsible for product supply.

CytoFab is an anti-TNF-alpha polyclonal antibody fragment product that is being developed for the treatment of severe sepsis.