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DewDiligence

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Tuesday, 01/22/2008 2:25:47 AM

Tuesday, January 22, 2008 2:25:47 AM

Post# of 19309
First Patient Dosed in AZN’s CytoFab Sepsis Trial

[The CytoFab sepsis program was derailed in late 2006 by what appears to have been a manufacturing problem, although AZN never formally admitted this was the reason for the delay (#msg-14499024). An all-new phase-2 program is now underway with “the revised, scaled up manufacturing process.” Please see #msg-13102354 for data from the prior phase-2 trial.]

http://biz.yahoo.com/iw/080122/0351126.html

>>
Protherics PLC announces Research Update

CytoFab™ phase 2 programme in severe sepsis commenced by AstraZeneca

Tuesday January 22, 2:02 am ET

Cheshire, UK--(MARKET WIRE)--Jan 22, 2008 --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 CytoFabTM 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 CytoFabTM, where AstraZeneca is responsible for its global development and commercialisation and Protherics for the supply of CytoFabTM 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 CytoFabTM 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 CytoFabTM 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".
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