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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

an extension in half-life of 5.3 times that of the current recombinant FIX therapy. 

Innovative Look at Tissue Distribution of rIX-FP Produce Early Results Presented at ASH

CSL Behring presented data at the American Society of Hematology on the tissue distribution of rIX-FP that demonstrated that rIX-FP was detectable five times longer in the tissues, including the bone. The extent and speed of onset of tissue penetration were similar for both rIX-FP and the study comparator product.

"These results demonstrate that rIX-FP was detectable significantly longer than the study comparator product, though they both behave in essentially the same way in terms of speed of onset and tissue penetration," said Dr. Stefan Schulte , Vice President of Research and Development at CSL Behring. "These results provide further evidence that rIX-FP is an extended half-life recombinant factor IX with the potential to reduce the number of injections needed in patients receiving prophylaxis from two or three injections per week with the study comparator product, to once weekly or significantly less frequently with rIX-FP. Further, they show that rIX-FP may have the potential to improve compliance and ease prophylaxis. This may, in turn, improve the quality of life for people with hemophilia B."

CSL Behring is currently recruiting patients for its adult phase II/III and pediatric phase III trials, the final phase of the PROLONG-9FP clinical trial program. More information can be found at www.clinicaltrials.gov.

About Hemophilia
Hemophilia is a congenital bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. In nearly all cases, it affects only males. The disease is caused by deficient or defective blood coagulation proteins known as factor VIII or IX. The most common form of the
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