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All About Bleeding

F1000 Medical Research Posters - Recombinant Factor Therapies

The following posters about recombinant factor therapies are provided as resources and can be found on F1000.com.

  • Population pharmacokinetic model for a novel recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in hemophilia B patients
    Ridhi Parasrampuria, Rachael Easton, Zhenling Yao, et al. F1000Posters 2015, 6: 217 (poster) [English] Background / Purpose: rIX-FP is a recombinant fusion protein linking coagulation FIX with albumin (rIX-FP). PK data were obtained from two clinical studies with rIX-FP in hemophilia B subjects. The aim of the population PK was to characterize PK of rIX-FP and evaluate less frequent administration of rIX-FP for prophylactic treatment. Summary

  • Efficacy, Safety and Pharmacokinetic results of a phase II/III, multicentre, double-blinded, randomized, cross-over study with a plasma-derived von Willebrand Factor/factor VIII concentrate (Voncento®) in subjects with hemophilia A (The SWIFT-HA study)
    A Klukowska, A Skotnicki, T J Lissitchkov, et al. F1000Posters 2015, 6: 214 (poster) [English] Background / Purpose: The SWIFT (“Studies with von Willebrand factor/Factor VIII”) program is evaluating the PK, efficacy and safety of a low-volume, highly active, plasma-derived von Willebrand Factor (VWF)/factor VIII (FVIII) concentrate (Voncento® or Biostate®, CSL Behring) containing a large proportion of high-molecular-weight VWF multimers and a VWF:FVIII ratio of 2.4:1 in hemophilia A and VWD patients. Summary

  • Pharmacokinetic, Efficacy and Safety Results of an Open-label, Multi-centreStudy with a plasma-derived von Willebrand Factor/factor VIII concentrate (Voncento®) in Subjects with Von Willebrand Disease (The SWIFT-VWD study)
    A Klukowska, T J Lissitchkov, E Buevich, et al. F1000Posters 2015, 6: 215 (poster) [English] Background / Purpose: The SWIFT (“Studies with von Willebrand factor/Factor VIII”) program is evaluating the PK, efficacy and safety of a plasma-derived von Willebrand Factor (VWF)/factor VIII (FVIII) concentrate (Voncento® or Biostate®, CSL Behring) in hemophilia A and VWD patients. Summary

  • Functional characterization of a novel single-chain recombinant human coagulation factor VIII product (rVIII-SingleChain)
    Carsten Horn, Burkhard Watzka, Hubert J Metzner, Gerhard Dickneite, Stefan Schulte F1000Posters 2015, 6: 218 (poster) [English] Background / Purpose: CSL Behring is developing a novel single‐chain recombinant human coagulation factor VIII product (rVIIISingleChain) for the prophylaxis and treatment of acute bleeding episodes in hemophilia A patients. Summary

  • Biodistribution of the recombinant fusion protein linking coagulation factor rVIIa with recombinant albumin
    Eva Herzog, Stephen Harris, Andrew McEwen, et al. F1000Posters 2015, 6: 216 (poster) [English] Background / Purpose: This study was conducted to investigate the biodistribution of the recombinant fusion protein linking coagulation factor VIIa with albumin, rVIIa-FP, compared with rFVIIa and albumin. Summary

  • Quantitative whole body autoradiography (QWBA) study on the effect of albumin fusion on the biodistribution of recombinant factor rFIX
    E Herzog, S Harris, A McEwen, I Pragst, G Dickneite, S Schulte, S Zollner F1000Posters 2014, 5: 106 (poster)   Background / Purpose: The recombinant fusion protein linking the human coagulation factor IX to albumin (rIX-FP) is currently investigated in clinical phase II/III trials (PROLONG-9FP) for prophylaxis and on-demand treatment of bleeding in haemophilia B patients. However, to date, there is only limited information available on the tissue distribution of factor IX products following intravenous administration. The present study was designed to explore the effects of albumin fusion on the biodistribution of recombinant factor IX. Summary

  • Safety and Pharmacokinetics of a Recombinant Fusion Protein-Linking Coagulation Factor VIIa with Albumin (rVIIa-FP) in Healthy Volunteers
    A Veldman F1000Posters 2014, 5: 105 (poster)   Background / Purpose: Development of neutralizing antibodies remains the most problematic complication in the treatment of patients with congenital haemophilia. Therapy with the bypassing agent rFVlla is limited by the short half-life of the commercially available product. Here, we report on pharmacokinetics and safety of a novel, recombinant fusion protein linking coagulation factor VIIa with albumin (rVlla-FP) in a placebo controlled, first-in-man study in healthy male subjects. Summary

  • N-Glycosylation of rVIII-SingleChain, a novel recombinant single-chain factor VIII
    S Schmidbauer, R Witzel, L Robbel, T Weimer, H Metzner, S Schulte F1000Posters 2014, 5: 134 (poster)   Background / Purpose: rVIII-SingleChain represents a novel type of a factor VIII (FVIII) product, a homogeneous recombinant single-chain FVIII that is currently under clinical development. Commercially available FVIII products so far are two-chain molecules consisting of light and heavy chains. In this study the N-glycosylation pattern of rVIII-SingleChain was investigated and was also compared to different commercially available rFVIII products. Summary

  • Pre-clinical safety and prolonged pharmacokinetic/pharmacodynamic (PK/PD) properties of a recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP)
    S Zollner, D Schurmann, F Kaspereit, et al. F1000Posters 2014, 5: 124 (poster)   Background / Purpose: Recombinant factor VIIa (rFVIIa) is approved to control bleeding in haemophilia patients who developed inhibitory antibodies to replacement therapy. rFVIIa is rapidly eliminated with a terminal half-life of approximately 2.5 hours in humans. This short half life of rFVIIa necessitates frequent injections and considerably limits prophylactic use. A recombinant fusion protein linking activated factor VII with albumin (rVIIa-FP) was therefore developed to extend the half life of rFVIIa. Summary

  • Pre-clinical pharmacokinetic/pharmacodynamic (PK/PD) characteristics of rVIII-SingleChain, a novel recombinant single-chain FVIII
    S Zollner, E Raquet, A Feussner, et al. F1000Posters 2014, 5: 152 (poster)   Background / Purpose: rVIII-SingleChain, a novel recombinant coagulation factor VIII, produced and formulated without added animal- or human-derived materials, is under development at CSL Behring in the clinical trial program AFFINITY. The present nonclinical studies were conducted in animals to gather knowledge about the PK/PD characteristics and as a result may enable a more precise estimate of the haemodynamic efficacy of rVIII-SingleChain for future clinical use in haemophilia A patients. Summary

  • Preclinical efficacy and safety of CSL627 novel recombinant, single-chain FVIII
    S Zollner, E Raquet, J Müller-Cohrs, et al. F1000Posters 2012, 3: 308 (poster)   Background / Purpose: CSL Behring is developing a novel recombinant, single-chain FVIII (CSL627) produced and formulated without added animal- or human-derived materials. Summary

  • Preclinical efficacy and safety of rVIII-single chain, a novel recombinant single-chain FVIII
    S Zollner, E Raquet, A Feussner, et al. F1000Posters 2012, 3: 1590 (poster)   Background / Purpose: To develop a novel recombinant FVIII for the treatment of hemophilia. Summary

  • Concept and structure model of factor IX albumin fusion proteins
    C Horn, H Steuber, I Baker, et al. F1000Posters 2012, 3: 1 (poster)   Background / Purpose: Improvement of the pharmacokinetic properties of coagulation factor IX (FIX) is a desired goal and has the potential to increase convenience and compliance of the treatment of severe haemophilia B patients by reducing the dosing frequency. A concept for increasing the half-life of FIX was developed based on FIX albumin fusion proteins (rIX-FPs) with cleavable linkers (1). Summary

  • Prolonged in vivo half-life of recombinant FVIIa by fusion to albumin
    T Weimer, W Wormsbächer, U Kronthaler, W Lang, U Liebing, S Schulte F1000Posters 2012, 3: 2 (poster)   Background / Purpose: For the treatment of hemophilia patients with inhibitors, recombinant Factor VIIa (rVIIa) is available as a therapeutic option to control bleeding episodes with a good balance of safety and efficacy. The short in vivo half-life of approximately 2.5 hours requires multiple injections, which is inconvenient for treaters and patients. Described here is the generation of a FVIIa molecule with significant in vivo half-life extension. Summary

  • Concept and structure model of factor VIIa albumin fusion proteins
    C Horn, H Steuber, T Weimer, et al. F1000Posters 2012, 3: 4 (poster)   Background / Purpose: Activated factor VII (FVIIa) is a therapeutic option for the treatment of bleeding episodes of haemophilia patients with inhibitors. An improvement of the pharmacokinetic properties of FVIIa is desirable as it may extend the applicability and increase the convenience of this treatment by reducing the dosing frequency. Summary

  • Prolonged serum half-life of a recombinant, albumin-fused, human coagulation factor IX (rIX-FP) in different animal species
    S Zollner, HJ Metzner, T Weimer, E Raquet, ..., MW Nolte, I Pragst, S Schulte, G Dickneite F1000Posters 2011, 2: 1192 (poster)   Background / Purpose: Recombinant human factor IX is widely used to control and prevent hemorrhagic episodes in hemophilia B patients. Recombinant expression of a coagulation factor IX human albumin fusion protein was used to delay rapid systemic elimination of factor IX in vivo. Summary

  • Prolonged plasma half-life of a recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) in different preclinical species
    G Dickneite, S Zollner, T Weimer, et al. F1000Posters 2011, 2: 1905 (poster)   Background / Purpose: Recombinant factor VIIa (rFVIIa) is approved to control bleeding in haemophilia patients, who have developed inhibitors. rFVIIa is rapidly eliminated with a terminal half-life between 1 and 5 hours in humans. This short-half life necessitates frequent injections and considerably limits prophylactic use. A recombinant fusion protein, linking activated factor VII with albumin (rVIIa-FP), was employed to delay systemic elimination. The aim of the present studies was to gather data about the pharmacokinetic behaviour of rVIIa-FP in different preclinical species to enable a more precise prediction of the kinetic profile of rVIIa-FP in human subjects. Summary

  • Pharmacokinetics of a recombinant albumin-fused, human coagulation factor VIIa (rVIIa-FP) exhibiting prolonged serum half-life in different animal species
    S Zollner, T Weimer, S Stefan, et al. F1000Posters 2011, 2: 1906 (poster)   Background / Purpose: Recombinant activated factor VII (rFVIIa) is established for the treatment of bleeding episodes and for prevention of bleeding during invasive procedures in patients with congenital haemophilia A or B with inhibitors to coagulation factors VIII or IX or in those expected to have a high anamnestic response to factors VIII or IX, acquired haemophilia, congenital FVII deficiency as well as Glanzmann’s thrombasthenia refractory to platelet transfusion. Summary

Last Updated: 4/22/2015 5:46 PM
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