Biogen Idec and Swedish Orphan Biovitrum recently announced the results of a Phase 1/2a clinical trial of the companies’ long-lasting recombinant factor VIII Fc fusion protein (rFVIIIFc). The advantage of a longer-lasting product is a reduction in the number of weekly infusions for hemophilia A patients. The data were presented at the XXIIIrd Congress of the International Society on Thrombosis and Haemostasis in Kyoto, Japan, on July 26, 2011.
A-LONG, the global clinical trial launched in late 2010, is a multicenter study designed to evaluate the safety, efficacy and pharmacokinetics (processing and duration of drug’s effect in the body) of rFVIIIFc in previously treated patients with hemophilia A. rFVIIIFc was well tolerated and demonstrated an approximately 1.7-fold increase in half-life when compared with an existing recombinant factor VIII product (rFVIII) in 16 previously treated patients with severe hemophilia A. According to the July 26th press release, the findings were seen “consistently across all patients and dose levels.”
“This trial is a step toward addressing the significant unmet need for a long-lasting recombinant factor VIII product,” said Neil Josephson, MD, Co-Principal Investigator of the Phase 3 rFVIIIFc A-LONG trial and associate professor of Medicine in the Division of Hematology at the University of Washington School of Medicine in Seattle. “Results from the Phase 1/2a study show that rFVIIIFc has an extended half-life, which may have the potential to provide extended protection from bleeding and reduce the number of infusions necessary for prophylactic treatment of severe hemophilia A.”
The trial will eventually expand to 60 centers worldwide, with approximately 150 patients. The patients will be divided into high-dose, low-dose and on-demand groups.
Biogen Idec press release dated July 26, 2011