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New Findings Support Less Frequent Dosing In Hemophilia B Patients Treated With Coagulation Factor IX With Recombinant Albumin (rIX-FP)

Stocks in this article: CSL

MELBOURNE, Australia, May 11, 2014 /PRNewswire/ -- Interim Phase II/III and III findings presented today by CSL Behring at the World Federation of Hemophilia (WFH) 2014 Congress demonstrate an improved pharmacokinetic (PK) profile of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP) among hemophilia B patients of all age groups. These findings suggest an improvement in hemophilia B treatment by allowing a prolonged routine prophylaxis treatment interval of 14 days or potentially longer, compared to the current standard of two to three times per week.  Data were presented during an oral session at the WFH Congress in Melbourne, Australia.  CSL Behring is a subsidiary of CSL Limited (CSL: ASX), a biopharmaceutical company with headquarters in Melbourne, Australia.

"Patients with hemophilia B and treating physicians are eager for innovative products that are able to decrease the dosing frequency while being effective and reliable in the prevention or treatment of bleeding episodes," said Elena Santagostino, MD, Ph.D., and lead investigator of this study.  "Our interim PK data from two Phase III studies, combined with the Phase I and I/II results, demonstrate that rIX-FP has the potential to satisfy this unmet need by offering a longer dosing interval and fewer injections."

"This data provides further encouragement to our ongoing efforts to bring forward to hemophilia patients an improved treatment option that will improve their quality of life," said Charmaine Gittleson, CSL Behring Senior Vice President of Clinical Research and Development. "We look forward to completing this study and moving into the next steps with this promising clinical candidate."

The interim pharmacokinetic results from the two phase III trials were based on the analysis of pharmacokinetic samples over the course of 14 days in 68 severe hemophilia B patients, ages from 1 to 61 years.   A single dose of 50 IU/kg rIX-FP gave a mean FIX activity level above 3% at 14 days in all age ranges.  In a paired comparison, the PK profile of rIX-FP demonstrated a 30 to 40 percent greater incremental recovery and greater than five times longer half-life, along with over five-fold larger area under the curve (AUC) and slower clearance compared with patients' previous plasma-derived and recombinant FIX products.

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