This excerpt taken from the PTIL 6-K filed Jun 3, 2008.
(for sepsis resulting from uncontrolled infection) phase 2 study commenced by AstraZeneca
an anti-TNF-alpha polyclonal antibody fragment (Fab) for the treatment of sepsis,
out-licensed to our partner, AstraZeneca, in December 2005.
It is estimated that sepsis affects around 3 million people worldwide per annum and kills one in three patients. Protherics believes that the severe sepsis market
has the potential to be worth up to $8 billion per annum
Protherics previously reported encouraging
data from an
81 patient phase 2b study with CytoFab
in severe sepsis.
In January 2008, AstraZeneca commenced an additional phase 2 programme with CytoFab
following changes to the
commercial manufacturing process. AstraZeneca's phase 2 programme 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 new manufacturing process. It will enrol up to 70 patients across multiple sites in the
and is expected to report towards the end of the year or
early 2009. Following the successful completion of this study, AstraZeneca intends to start a second study to assess both the safety and the efficacy of CytoFab
in a much larger patient group. Protherics will receive its next milestone payment of £10 million from AstraZeneca upon the start of a pivotal phase 3 study which is anticipated in 2010.