CSL Behring announced last month that the first patient had been enrolled in a phase III clinical study to evaluate the safety, efficacy and pharmacokinetics of recombinant fusion protein linking coagulation factor IX (FIX) with recombinant albumin (rIX-FP) in previously treated children up to 11 years old. rIX-FP is engineered to extend the half-life of FIX through genetic fusion with a recombinant form of albumin, a water-soluble protein in blood.
rIX-FP is being developed through the PROLONG-9FP clinical trial program for the treatment of bleeding episodes in patients with congenital factor IX deficiency (hemophilia B). This includes routine prophylactic treatment, control and prevention of bleeding episodes, and prevention and control of bleeding in perioperative settings. The study site for this first enrollment is the Czech Republic. Phase I study results showed that rIX-FP extended the half-life of the product to 91.5 hours, 5.3 times longer than existing rIX therapies.
“CSL continues to advance at a very encouraging rate with our recombinant coagulation factor development program,” said Andrew Cutherbertson, PhD, 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.”
Source: CSL Behring news release dated January 21, 2013