CSL Behring announced today the first in human dosing of recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP). The Phase I study will investigate in healthy volunteers the safety and pharmacokinetics of rVIIa-FP in comparison to placebo. CSL Behring, in collaboration with its parent company, CSL Limited (ASX: CSL), is developing rVIIa-FP, a novel therapy to treat hemophilia A and hemophilia B patients who have inhibitors as part of the PROLONG 7- FP clinical study program. For more information about this study, please see www.clinicaltrials.gov.
CSL Behring's albumin fusion technology uses albumin as the ideal recombinant genetic fusion partner for coagulation factor proteins due to its inherently long half-life, high potential for tolerability, known mechanism of clearance and low potential for immunogenic reactions. CSL Behring's rVIIa albumin fusion protein is expected to exhibit a good tolerability profile and improved pharmacokinetics that may enable prophylaxis.
CSL Behring's rVIIa-FP was previously granted Orphan Drug Designation by the European Commission and the United States Food and Drug Administration.