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CSL Behring enrolls first patient in global pediatric Phase III pivotal study of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) to treat hemophilia B
Date:1/21/2013

KING OF PRUSSIA, Pa., Jan. 21, 2013 /PRNewswire/ -- CSL Behring has announced that the first patient has been enrolled in the pivotal pediatric phase III study to evaluate the safety, efficacy and pharmacokinetics of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP) in previously treated children (up to age 11 years). The study site for this first enrollment is the Czech Republic.

"CSL continues to advance at a very encouraging rate with our recombinant coagulation factor development program," said Dr. Andrew Cutherbertson , Chief Scientist, CSL Limited. "The long history of profound expertise and commitment CSL brings to developing safe and effective therapies to improve the lives of those affected by rare and serious bleeding disorders remains the key to our ongoing success in this therapeutic area. With each clinical milestone we meet, we draw closer to our goal of bringing another truly innovative new treatment option to patients."

CSL Behring, in collaboration with its parent company, CSL Limited (ASX:CSL), is developing rIX-FP through the PROLONG-9FP clinical trial program for the prophylaxis and treatment of bleeding episodes, including control and prevention of bleeding in surgical settings in patients with factor IX deficiency.

Results of a Phase I study evaluating recombinant fusion protein linking coagulation factor IX  with albumin (rIX-FP) in patients with severe hemophilia B were publicly presented earlier this year and published in BLOOD 2012 showing that rIX-FP achieved a 91.57 hours terminal half-life, incremental recovery of 1.376 (IU/dL) / (IU/kg), and clearance of 0.75 mL/h/kg.  This was
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