Last month, pharmaceutical companies Biogen Idec and Biovitrum AB announced their plan to advance the companies’ long-acting, fully recombinant factor IX Fc fusion protein (rFIXFc) into a registrational clinical trial in patients with hemophilia B.
According to the October 19, 2009, news release, the decision to move forward with the program is based on “promising data” from a Phase I/IIa open-label, multi-center, safety dose-escalation and pharmacokinetic study of intravenous rFIXFc in severe, previously treated hemophilia B patients. The companies reported that rFIXFc was well tolerated in the study. Trial data showing rFIXFc’s prolonged half-life compared to “historical data” for current therapies further strengthened the case for advancing rFIXFc.
“rFIXFc is an example of Biogen Idec’s commitment to developing innovative therapies to address significant unmet medical needs. The rFIXFc program has the potential to improve the lives of individuals with hemophilia B and we are excited about advancing the program,” said Glenn Pierce, PhD, MD, Vice President and Chief Medical Officer of Biogen Idec’s hemophilia therapeutic area.
“The Phase I/II results are very encouraging. The decision to initiate our first registrational program represents true progress in our efforts to offer hemophilia B patients treatment that makes a significant difference and is also an important milestone in the ongoing development of Biovitrum,” said Martin Nicklasson, Biovitrum CEO.
Source: Biogen Idec news release dated October 19, 2009