CSL Behring has commenced the patient enrollment in pivotal pediatric Phase III hemophilia B study of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP).
The study is designed to assess rIX-FP’s safety, efficacy and pharmacokinetic profile in children who previously received treatment.
CSL Behring along with its parent company, CSL Limited, is developing rIX-FP by means of the PROLONG-9FP clinical trial program.
The program aims at prevention and treatment of bleeding events in patients with factor IX deficiency.
CSL Limited chief scientist Dr. Andrew Cutherbertson said the company is advancing the recombinant coagulation factor development program.
“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,” Cutherbertson added.
rIX-FP established positive results in the phase I study, conducted in hemophilia B patients, demonstrating an extension in half-life of 5.3 times compared to existing recombinant FIX therapy.
According to the study data concerning the tissue distribution, rIX-FP was detectable significantly longer than the study comparator product in the tissues such as the bone.
CSL Behring research and development vice president Dr. Stefan Schulte said, “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.”