CSL Behring reported results from a pre-clinical study that demonstrates a new means of prolonging the half-life of factor VIIa (FVIIa), a key therapeutic protein required for blood clotting. The data were presented at the American Society of Hematology’s 49th Annual Meeting, December 8-11, 2007, in Atlanta, GA. The method involves genetically “fusing” FVIIa to human albumin, a soluble and abundant protein found in human blood plasma. In rat models, the half-life of recombinant FVIIa (rFVIIa) with the albumin fusion protein (rVIIa-FP) was extended six to nine times when compared to rFVIIa alone.
While recombinant rFVIIa can effectively control bleeding episodes in hemophilia A and B patients with inhibitors, its short half-life – approximately 2.5 hours according CSL – means that repeated infusions are often necessary. A longer-lasting rVIIa therapy could mean fewer infusions and greater convenience both for patients and for physicians during surgery.
“A major unmet need in hematology is improving the pharmacokinetic parameters of coagulation factors, such as half-life, while retaining full hemostatic activity,” said Dr. Stefan Schulte, Head Pre-clinical R&D, CSL Behring and lead investigator of the study. “The pharmacological properties of rVIIa-FP seen in our study could one day facilitate a single dosing regimen of one injection per bleeding event, as well as significantly reduce the number of injections hemophilia patients with inhibitors need during surgical interventions.”
Source: CSL Behring press release dated December 10, 2007
In an unrelated development, CSL Behring announced that Helixate®FS, its recombinant factor VIII product for the treatment of hemophilia A, will now be available in a new 2,000 IU (international unit) vial size. According to the company, the larger vials are more convenient for patients on higher doses of Helixate® FS.
Source: CSL Behring press release dated December 21, 2007