CSL Behring Study in Animal Models Shows Feasibility of Developing a Half-Life Extended Recombinant FVIIa that Retains Biologi...(ing is pleased to be at the forefront of...),Health

Date:12/10/2007

ing is pleased to be at the forefront of this exciting development in hemophilia treatment, which is consistent with our mission to improve the lives of patients with bleeding disorders," said Dr. Andrew Cuthbertson, Chief Scientific Officer at CSL Ltd., parent company of CSL Behring. "By increasing convenience and compliance, rVIIa-FP has the potential to benefit hemophilia patients with inhibitors and the physicians who treat those patients. We look forward to continuing our research and accumulating additional data to validate the results seen in our pre-clinical study of this molecule."

Today's Presentation: Study Design

Genetic fusion to albumin is an efficient way to extend the half-life of small proteins, but so far it has not been successfully used for the half-life extension of complex proteins. In the presented proof-of-principle study, rVIIa-FP was generated by genetic engineering, expressed in mammalian cell culture, purified and characterized. The rVIIa-FP displayed full biological activity and 6 to 9-fold extended half-life compared to either Novoseven(R)(1), a recombinant FVIIa, or rVIIa control protein in a pre-clinical rat model. The superior pharmacological properties of the rVIIa-FP could facilitate a single dosing regimen of one injection per bleeding event for treatment of hemophilia inhibitor patients.

About Hemophilia with Inhibitors

In some patients with hemophilia, the immune system produces an antibody that blocks the action of the substituted coagulation factor and prevents clot formation. This antibody is known as an inhibitor, and its presence makes treatment of bleeding episodes more difficult. The reason inhibitors develop is unknown, although people with hemophilia have the greatest risk for developing an inhibitor during childhood. The incidence of inhibitors is highest among those with severe hemophilia, followed by moderate and mild deficiency. The risk of inhibitor development is higher if someone in th
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