London, UK, 29 July 2009: BTG plc (LSE: BGC), the specialty pharmaceuticals company, today announces that its partner 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 CEO, 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.”
John Rex, Vice-President for Clinical Infection, AstraZeneca, said: “AstraZeneca is aiming to build a leading franchise in the treatment of infectious diseases through our own research and collaborations such as this partnership with BTG. Sepsis is a serious medical problem and CytoFab™ represents a novel approach to this area of unmet medical need.”
