CSL Behring has commenced patient enrolment in its pivotal paediatric Phase III Haemophilia B study designed to assess the recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP) for its safety, efficacy and pharmacokinetic profile.
CSL Behring and its parent company, CSL Limited, are jointly developing rIX-FP through the PROLONG-9FP clinical trial programme, which is designed to prevent and treat bleeding episodes in factor IX-deficient patients.
Children up to 11 years of age, who have previously received treatment, are participating in the study.
CSL Limited chief scientist Dr Andrew Cutherbertson said the company is advancing the recombinant coagulation factor development programme at an encouraging rate.
"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 said.
According to data from a Phase I study conducted in patients with severe haemophilia B, rIX-FP has demonstrated a half-life extension of 5.3 times more than existing recombinant FIX therapy.
Tissue distribution study data also showed that rIX-FP was detectable for notably longer than the study comparator product, though the degree and speed of tissue penetration were alike.
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."