Protherics PLC and AstraZeneca has announced AstraZeneca's intention to expand the development plan for CytoFab, a treatment for severe sepsis, with the addition of a 480 patient phase II study programme. AstraZeneca has recently completed consultations with regulators in the US 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 programme 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 as providing further supporting efficacy and safety data. This may enable a shorter timetable for the phase III programme than originally anticipated by AstraZeneca.
The phase II programme will start in the second half of 2007 and is expected to last up to 21 months. It will be immediately followed by the initiation of the phase III study in the US, EU and Japan. Under the terms of the licensing agreement, AstraZeneca is responsible for conducting and funding the global development of CytoFab and Protherics is responsible for product supply.
John Rex, vice president, medical director for infection, AstraZeneca, said:
"Our goal is to optimise 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. To increase the likelihood of success in this complex disease and reflecting the changing regulatory environment for biologics, we have made the decision to undertake additional clinical work. We hope that this will help to reduce the size of and the time needed to complete the phase III study.
We believe that this development plan will give us the best chance of successful registration for this exciting treatment."Andrew Heath, chief executive of Protherics, said,"CytoFab represents a major market opportunity and AstraZeneca's proposed development programme provides the treatment with the best route to registration. We now have a clear view of the steps needed to make this important new treatment available to sepsis patients worldwide."