CSL Behring has announced that Vienna, Austria, will be the first site initiated in its global phase II/III, multi-center study to evaluate the safety, efficacy and pharmacokinetics of its recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP). The prospective, open-label study will enroll adolescents and adults (12-65 years of age) with hemophilia B. CSL Behring is working in collaboration with its parent company, CSL Limited, to develop rIX-FP for the prophylactic treatment of bleeding episodes in patients with hemophilia B.
The new site is part of the PROLONG-9FP clinical study program, which has established study sites in seven other countries. CSL also announced that additional trial sites will be established in Japan, Russia and the U.S. later this year.
“The unmet medical need is great for a factor IX product with an extended half-life for use in treating people with hemophilia B, a life-long, debilitating clotting disorder,” said Russell Basser, MD, Senior Vice President, Global Clinical R&D at CSL Behring. “Such a therapy can mean fewer injections for patients, and may enable or enhance prophylactic treatment. This would be an improved convenience that may result in a better quality of life for patients.”
Source: CSL Behring news release dated January 12, 2012