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news.Protherics has reported that AstraZeneca has treated the first patient in its expanded Phase II program of CytoFab in severe sepsis, an inflammatory condition resulting from uncontrolled infections.
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AstraZeneca’s Phase II program will consist of two separate studies in patients with severe sepsis. The first study, which is now underway, is designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CytoFab produced by the revised, scaled up manufacturing process. It will enroll up to 70 patients across multiple sites in the US and the study is expected to report in twelve months’s time. Following the successful completion of this study, a second study will be conducted to assess both the safety and the efficacy of CytoFab in a larger patient group.
Andrew Heath, CEO of Protherics, said: “We have an excellent partner in AstraZeneca and look forward to further progress of CytoFab in this important area of critical care.”