Biogen Idec and Swedish Orphan Biovitrum Announce First Patient Dosed in Trial of Long-Acting Hemophilia B Therapy

26-Jan-2010 - USA

Biogen Idec and Swedish Orphan Biovitrum y 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.

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.

Using the same proprietary technology as rFIXFc, Biogen Idec and Swedish Orphan Biovitrum are also developing a fully-recombinant, long-acting Factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. rFVIIIFc is currently being evaluated in a Phase I/IIa, open-label, dose-escalation, multicenter study to evaluate the safety, tolerability and pharmacokinetics of rFVIIIFc in hemophilia A patients. For more information on the rFIXFc and rFVIIIFc trials, please visit www.biogenidechemophilia.com.

https://www.bionity.com/en/news/112285/biogen-idec-and-swedish-orphan-biovitrum-announce-first-patient-dosed-in-trial-of-long-acting-hemophilia-b-therapy.html