AstraZeneca to progress CytoFab into Phase IIb study

BTG, a UK specialty pharmaceuticals company, says that its partner', UK drug major AstraZeneca has confirmed its intention to progress CytoFab, an investigational biological medicine under development as a treatment for severe sepsis, into a Phase IIb study.

This decision follows the successful completion by AstraZeneca of a Phase IIa study of CytoFab in 70 patients with severe sepsis. The Phase IIa study was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple intravenous infusions of CytoFab.

The Phase IIb study in approximately 300 patients with severe sepsis is anticipated to start recruiting in early 2010. Louise Makin, BTG's chief executive, commented: 'We are encouraged by AstraZeneca's decision to progress CytoFab into a Phase IIb study. We look forward to continuing to work with AstraZeneca to develop CytoFab as a potential treatment for severe sepsis, which is responsible for many thousands of deaths each year and remains a
significant unmet medical need.'