Entering new areas in known fields: recombinant fusion protein linking recombinant factor VIIa with recombinant albumin (rVIIa-FP) - advancing the journey.
The novel fusion protein linking recombinant factor VIIa with recombinant albumin (rVIIa-FP) is designed to extend the half-life of recombinant factor VIIa (rFVIIa) and improve the care of hemophilia A or B patients with inhibitors. Preclinical studies in various animal models have demonstrated markedly improved pharmacokinetic and pharmacodynamic properties, as well as prolonged retention in the joint tissues, of rVIIa-FP compared with a commercially available rFVIIa (NovoSeven®). A phase I study in healthy volunteers - the first study in the PROLONG-7FP program - confirmed that rVIIa-FP has a good tolerability profile in doses of up to 1,000μg/kg and has demonstrated enhanced pharmacodynamic activity relative to rFVIIa. The half-life of rVIIa-FP at the highest dose investigated in the study was 8.5hours, which represents a 3- to 4-fold half-life extension compared with rFVIIa. Encouraging results from preclinical and phase I studies have led to the initiation of clinical studies of rVIIa-FP in patients with congenital hemophilia A or B and inhibitors, and in patients with confirmed factor VII deficiency. The results from these studies are awaited with interest by clinicians and patients alike.
Hemophilia Comprehensive Care Center and Hematology Department, Louis Pradel University Hospital, Lyon, France. Electronic address: claude.negrier@chu-lyon.fr.
Claude
C
Négrier
D000818:Animals; D017321:Clinical Trials, Phase I as Topic; D004353:Drug Evaluation, Preclinical; D015942:Factor VIIa / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D006467:Hemophilia A / Q000628:therapy*; D002836:Hemophilia B / Q000628:therapy*; D006801:Humans; D011993:Recombinant Fusion Proteins / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use; D012709:Serum Albumin / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*
D011993:Recombinant Fusion Proteins; D011994:Recombinant Proteins; D012709:Serum Albumin; C103587:recombinant FVIIa; D015942:Factor VIIa
Hemophilia A; Hemophilia B; Inhibitors; NovoSeven®; PROLONG-7FP; rVIIa-FP