In a pair of recent news releases, Biogen Idec and Swedish Orphan Biovitrum reported on the progress of therapies for people with hemophilia A and B.
On July 9, the companies announced that they plan to advance a long-lasting, fully recombinant factor VIII Fc fusion protein (rFVIIIFc) into a clinical trial for people with hemophilia A. According to the news release, the therapy is moving to the next stage in light of “promising data” from a Phase 1/2a open-label study that evaluated the safety and pharmacokinetics of rFVIIIFc in 16 previously treated patients with severe hemophilia A. Compared to current treatments, there was a prolonged half-life (when a drug has reached half strength in the blood) at various dosing levels. Further, there were no adverse reactions and no patients developed inhibitors.
“We are excited to announce the advancement of rFVIIIFc into a registration (global) study. Like our long-lasting hemophilia B program, which entered a registration trial earlier this year, rFVIIIFc offers the potential to make a significant difference in the lives of people with hemophilia,” said Glenn Pierce, MD, PhD, Vice President and Chief Medical Officer of Biogen Idec’s hemophilia therapeutic area.
On July 12, the companies announced the results from a Phase 1/2a study that measured the safety and pharmacokinetics of long-lasting, fully recombinant factor IX Fc fusion protein (rFIXFc) in 14 previously treated patients with severe hemophilia B. The data showed that rFIXFc was well tolerated and demonstrated an approximately three-fold increase in half-life compared to historical data for existing therapies. Minor side effects were reported in two patients—headache and altered taste. The results were presented at the World Federation of Hemophilia Congress in Buenos Aires, Argentina, on July 11.
“Current prophylactic regimens for hemophilia B require intravenous injections twice per week, so there is great desire among physicians and patients for a therapy that will provide prolonged protection from bleeding,” said Amy Shapiro, MD, Medical Director of the Indiana Hemophilia and Thrombosis Center. “Results from the Phase 1/2a trial show that rFIXFc may be able to reduce the number of injections to once weekly or less, which would be an important advancement for the hemophilia community.”
Source: Biogen Idec news releases, July 9 and July 12, 2010