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news.AstraZeneca and Protherics are facing delays in the development of an experimental drug for severe sepsis after they expanded its program to include an additional phase II study.
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AstraZeneca has completed consultations with regulators in the US and EU about the drug. In order to meet the regulatory needs of both agencies, AstraZeneca must implement a phase II study program to support a single global phase III study of CytoFab.
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 program than originally anticipated by AstraZeneca.
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 initiation of the phase III study in the US, EU and Japan.
“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, vice-president, Medical Director for Infection, AstraZeneca.
Under the licensing agreement for CytoFab, AstraZeneca is responsible for conducting and funding the global development of CytoFab and Protherics is responsible for product supply.