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First Patient Screened in CSL Behring Global Phase I/III Study of Recombinant Single-Chain Factor VIII
Date:2/24/2012

VIENNA, Feb. 24, 2012 /PRNewswire/ -- CSL Behring has announced that the first patient has been screened in its recombinant coagulation single-chain factor VIII (rFVIII) trial, part of the AFFINITY clinical trial program. The CSL Behring rFVIII, called 'rVIII-SingleChain', is a novel molecule being studied for the treatment of hemophilia A. It is being developed by CSL Behring, in collaboration with its parent company, CSL Limited (ASX: CSL).

"CSL is advancing at a very encouraging rate with our recombinant coagulation factor development program," said Dr. Andrew Cuthbertson, Chief Scientist CSL Limited. "Our ongoing commitment to providing safe and effective therapies to help improve the lives of those affected by hemophilia A and other rare bleeding disorders is being fulfilled with each milestone we reach. Our recombinant coagulation single-chain factor VIII molecule is showing strong promise. We look forward with excitement to seeing results of the phase I/III study in coming months."

About the AFFINITY Phase I/III Study
The Phase I/III study is an open-label, multicenter trial that examines the crossover safety, efficacy and pharmacokinetics of recombinant coagulation single-chain factor VIII compared with recombinant human antihemophilic factor VIII (octocog alpha). 

In Part 1 of the study, subjects will receive a single infusion of 50 IU/kg of octocog alpha followed by a single infusion of 50 IU/kg. In Parts 2 and 3 of the study, subjects will receive infusions of rVIII-SingleChain to prevent and treat bleeding (if required), at a dose and frequency determined by their study doctor (based on the subject's underlying bleeding phenotype). More information about the study design can be found at www.clinicaltrials.gov.  

Recombinant single-chain factor VIII consists of two linked
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SOURCE CSL Behring
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