Product
CytoFab™
Tumour Necrosis Factor Alpha (TNF-α) Immune Fab (Ovine)

Partner
AstraZeneca

Indication
Severe sepsis

Phase
Phase II

Description
Ovine polyclonal antibody fragment (Fab) which neutralises TNF-α; an inflammatory mediator strongly implicated in sepsis

Further Information
Sepsis is an inflammatory condition, resulting from uncontrolled infection. As the condition progresses, patients require intensive care as their organs fail and the situation becomes life threatening. With a staggering 30% mortality rate, up to three million lives a year are threatened by sepsis worldwide. Current treatment options for patients are extremely limited and there are very few products in late stage development.

CytoFab™ is an investigational new biologic product that might offer real promise for patients with sepsis. Results from a Phase IIb clinical study suggested that CytoFab™ decreased mortality and patients spent a significantly reduced number of days in the intensive care unit. AstraZeneca’s expanded Phase II programme is currently underway following changes to the manufacturing process, with a 70 patient study nearing completion. A 300 patient Phase IIb study is planned to start in early 2010.

CytoFab™ is licensed to AstraZeneca, who are responsible for the global development and commercialisation of the product. The agreement has a potential total deal value, excluding royalties, of approximately £195 million. BTG (at the time Protherics) received an initial payment of £16.3 million and a £7.5 million equity investment by AstraZeneca, and will receive additional payments worth up to £171 million payable upon the achievement of milestones.

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