Biogen
Idec (NASDAQ: BIIB) and Swedish
Orphan Biovitrum (STO: BVT) today announced that the first patient
was dosed in a registrational, open-label, multicenter trial designed to
evaluate the safety, pharmacokinetics and efficacy of the companies’
long-acting, recombinant Factor IX Fc fusion protein (rFIXFc) in
hemophilia B patients. The trial, called the B-LONG study, will
determine the efficacy of rFIXFc in the prevention and treatment of
bleeding in approximately 75 previously-treated patients with severe
hemophilia B.
“In a Phase
I/IIa study, rFIXFc showed the potential to prolong protection from
bleeding in severe, previously-treated patients with hemophilia B.”
“Hemophilia B requires frequent injections, often two to three times a
week, causing a major burden on individuals with the disorder,” said Amy
Shapiro, M.D., Principal Investigator of the B-LONG trial and Medical
Director of the Indiana Hemophilia and Thrombosis Center. “In a Phase
I/IIa study, rFIXFc showed the potential to prolong protection from
bleeding in severe, previously-treated patients with hemophilia B.”
rFIXFc is a fully-recombinant clotting factor developed using Biogen
Idec's novel and proprietary monomeric Fc-fusion technology. In the
B-LONG trial, rFIXFc’s ability to prevent bleeding using different
dosing regimens will be measured by evaluating the number of
breakthrough bleeding episodes annualized over the study period. The
study will also evaluate the efficacy of rFIXFc in on-demand and
surgical settings, and compare the pharmacokinetics of a single dose of
rFIXFc with a single dose of a commercially available recombinant Factor
IX product.