Biovitrum Advances Factor VIII Long-acting Hemophilia A Therapy Into Clinical Trials

Biovitrum has announced that the first patient was dosed in a Phase I/IIa study of its long-acting fully-recombinant Factor VIII Fc fusion (rFVIIIFc) protein. The Phase I/IIa open-label study will assess the safety, tolerability and pharmacokinetics of rFVIIIFc in severe, previously-treated, hemophilia A patients. The rFVIIIFc program and international study are partnered with Biogen Idec.

The rFVIIIFc molecule is being investigated for the potential to prolong protection from bleeding and reduce the frequency of injections for both prophylaxis and on-demand therapy in hemophilia A. Preclinical studies showed improved half-life of rFVIIIFc, which is based on Biogen Idec’s monomeric Fc-fusion technology, recently presented on December 7, 2009 at the American Society of Hematology conference.

Peter Edman, CSO of Biovitrum, said: “We are excited about bringing rFVIIIFc into the clinical stage together with Biogen Idec and, thereby adding another significant collaboration project to the ongoing recombinant Factor IX Fc fusion (rFIXFc) clinical program. The innovative rFVIIIFc program holds great potential in offering true value to hemophilia A patients, and is thus a prioritized therapeutic and business area within Biovitrum.”