In January, Biogen Idec and Swedish Orphan Biovitrum announced that the first three patients were dosed in a registrational, open-label, multicenter trial of the companies’ long-acting, recombinant factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. rFIXFc is developed using Biogen Idec’s novel and proprietary monomeric Fc-fusion technology.
“We are excited that rFIXFc is the first long-acting Factor IX therapy to enter registrational trials,” said Glenn Pierce, MD, PhD, vice president and chief medical officer of Biogen Idec's hemophilia therapeutic area. “We are making important progress in our efforts to develop a treatment that can make a difference to the hemophilia B community.”
The clinical trial, called the B-LONG study, will evaluate the safety, pharmacokinetics and efficacy of the product. Investigators will measure the effectiveness of rFIXFc in the prevention and treatment of bleeding in approximately 75 previously treated patients with severe hemophilia B. The study will evaluate the ability of rFIXFc to prevent bleeding at different doses. It will also determine the efficacy of using the product for on-demand treatments and in surgical settings.
“Hemophilia B requires frequent injections, often two to three times a week, causing a major burden on individuals with the disorder,” said Amy Shapiro, MD, principal investigator of the B-LONG trial and medical director of the Indiana Hemophilia & Thrombosis Center in Indianapolis. “In a Phase I/IIa study, rFIXFc showed the potential to prolong protection from bleeding in severe, previously-treated patients with hemophilia B.”
Using the same proprietary technology as rFIXFc, Biogen Idec and Swedish Orphan Biovitrum are also developing a recombinant, long-acting Factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. rFVIIIFc is undergoing a Phase I/IIa, open-label, dose-escalation, multicenter study to evaluate the safety, tolerability and pharmacokinetics of rFVIIIFc in hemophilia A patients.
Source: Biogen Idec news release dated January 25, 2010