London, UK; Brentwood, TN, US; 22 January 2008 - Protherics PLC (“Protherics” or the “Company”), the international biopharmaceutical company focused on critical care and cancer, today announces that AstraZeneca has treated the first patient in its expanded phase 2 programme of CytoFab™ in severe sepsis, an inflammatory condition resulting from uncontrolled infections.
Protherics previously reported encouraging phase 2b study results in an 81 patient study in severe sepsis. In December 2005, AstraZeneca and Protherics announced a licensing agreement for CytoFab™, where AstraZeneca is responsible for its global development and commercialisation and Protherics for the supply of CytoFab™ bulk drug substance.
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 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 approximately twelve months’ 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, Chief Executive of Protherics commented:
“We are very pleased that the first patient has been enrolled in the new CytoFab phase 2 programme and that CytoFab is once again being administered to patients with this life-threatening condition. We have an excellent partner in AstraZeneca and look forward to further progress of CytoFab in this important area of critical care.”
Dr John Rex, Vice President Clinical Infection, AstraZeneca commented:
“AstraZeneca and Protherics have both undertaken a considerable programme of work since the signing of the licensing agreement, and we are delighted that the phase 2 programme with CytoFab is underway”.
For further information please contact:
Protherics – Investor Relations
Andrew Heath, CEO +44 (0) 20 7246 9950
Nick Staples, Director of Corporate Affairs +44 (0) 7919 480510
Saul Komisar, President Protherics Inc +1 615 327 1027
Financial Dynamics – Media Enquiries
London: Ben Atwell, Lara Mott +44 (0) 20 7831 3113
New York: John Capodanno, Jonathan Birt +1 212 850 5600
AstraZeneca - Investor Relations
Mina Blair +44 (0) 207 304 5084
Jonathan Hunt +44 (0) 207 304 5087
Jörgen Winroth +1 (212) 579 0506
Ed Seage +1 302 886 4065
Karl Hard +44 207 304 5322
Peter Vozzo (MedImmune) +1 301 398 4358
AstraZeneca - Media Enquiries
Helen Wailes +44 (0) 1625 510 975
Edel McCaffrey +44 (0) 207 304 5034
Steve Brown +44 (0) 207 304 5033
