- |||||||||| Factor VIII is a regulator of angiogenesis and a promoter of endothelial barrier stability (111 A-C) - May 17, 2024 - Abstract #ISTH2024ISTH_2032;
A significant enhancement of EC functionality was demonstrated by treating HA BOECs with rFVIII products, with a higher positive effect for simoctocog alfa. Moreover, in NSG-HA mice treated with different rFVIII concentrates, and subsequently injected with Evans Blue dye, we showed a significant reduction of dye extravasation with a complete correction in mice treated with simoctocog alfa compared with other rFVIII products.
- |||||||||| Hemlibra (emicizumab-kxwh) / Roche, Nuwiq (simoctocog alfa) / Octapharma
miRNA expression profiles as a potential biomarker of joint and bone health in haemophilia A (111 A-C) - May 17, 2024 - Abstract #ISTH2024ISTH_2031; The validation study evaluated these 2 miRNAs. The results demonstrated that two miRNAs (miR- 208a-3p and 524-3p) were significantly underexpressed in plasma of patients with HArt compared to patients without arthropathy, with FDR < 0.05 (Figure 1).
- |||||||||| Nuwiq (simoctocog alfa) / Octapharma
Review, Journal: Simoctocog alfa (Nuwiq (Pubmed Central) - May 13, 2024 Optimal care of children should consider several factors, including minimization of inhibitor development risk, maintaining tolerance to FVIII, highly effective bleed prevention and treatment, safety, and impact on long-term outcomes such as bone and joint health. In this context we review the pediatric clinical data and ongoing studies with simoctocog alfa.
- |||||||||| Nuwiq (simoctocog alfa) / Octapharma
Factor VIII Is an Endothelial Factor That Promotes Vessel Stability (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5394; In conclusion, information about the possible extra-coagulative role of FVIII may be crucial to understand the key molecular targets missing in HA patients at the cellular level that impair EC functionality. Knowledge of the possible effect of different rFVIII products on ECs functionality can lead to new therapeutic approaches potentially resulting in safer and more efficient treatment of HA.
- |||||||||| Nuwiq (simoctocog alfa) / Octapharma
Journal: Simoctocog alfa (Nuwiq (Pubmed Central) - Sep 18, 2023 N=140 --> 200 Simoctocog alfa was efficacious and well tolerated as prophylaxis, surgical prophylaxis and for the treatment of BEs in PUPs with severe haemophilia A.
- |||||||||| Wilate (human factor VIII/von Willebrand factor) / Octapharma, Nuwiq (simoctocog alfa) / Octapharma, Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Observational data, Journal, Real-world evidence, Real-world: Design of a Real-World Observational Study in Previously Untreated and Minimally Treated Hemophilia A Patients: Protect-NOW. (Pubmed Central) - May 14, 2023 P=N/A The secondary objectives are to assess utilization patterns (including dosage and frequency of administration) and the effectiveness in surgical prophylaxis. Conclusions ?The Protect-NOW study will provide information on the treatment of PUPs and MTPs in routine clinical practice, which will help guide clinical decision making for treating these patients in the future.
- |||||||||| IN VITRO DIFFERENCES IN PLATELET BINDING AMONG RECOMBINANT FACTOR VIII PRODUCTS () - Feb 13, 2023 - Abstract #EAHAD2023EAHAD_267;
Simoctocog alfa showed increased binding to procoagulant platelets compared with other tested rFVIII concentrates. Further studies, including additional functional platelet assays, will be performed using samples from a larger number of healthy donors and from patients with haemophilia A. The results of this study may provide new insights into the function and efficacy of different rFVIII products in patients with haemophilia A.
- |||||||||| Binding to Platelets Differs Among Recombinant Factor VIII Products in Vitro () - Nov 29, 2022 - Abstract #ASH2022ASH_7006;
Conclusion s : Simoctocog alfa showed increased binding to procoagulant platelets compared with other rFVIII concentrates tested. Further studies, including additional functional platelet assays, will be performed using samples from a larger number of healthy donors and from patients with hemophilia A. The results of this study may provide new insights into the function and efficacy of different rFVIII products in patients with hemophilia A.
- |||||||||| Nuwiq (simoctocog alfa) / Octapharma
Factor VIII and Von Willebrand Factor Inhibit Osteoclastogenesis in a Humanized Cell Culture Model () - Nov 29, 2022 - Abstract #ASH2022ASH_7003; It is unknown whether the absence of factor VIII (FVIII) might play a direct causative role.Aim : To investigate the effect of recombinant FVIII (rFVIII, simoctocog alfa) and von Willebrand factor (vWF) on osteoclastogenesis in a humanized two-dimensional (2D) cell culture model...As osteoclastogenesis has a high donor-to-donor variation, we are currently testing more donors to see if dependencies on age or blood type exist. These data provide a first insight into mechanisms underlying the reduced bone mass observed in patients with hemophilia A.
- |||||||||| Nuwiq (simoctocog alfa) / Octapharma
Prophylactic Treatment of Severe Haemophilia a Patients with Inhibitors to FVIII with Peglip-FVIII (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_3892; The dosing interval of 5.5days at 35IU/kg represents a significant reduction in FVIII infusion frequency. Acknowledgements: The Authors acknowledge the co-operation of the following clinicians in undertaking the study: Nadezhda Zozulia1, Margarita Timofeeva2, Tatiana Pospelov32, Marina Kosinova4, Igor Kurtov5, Heghine Khachatryan6.
- |||||||||| Nuwiq (simoctocog alfa) / Octapharma
Journal: Efficacy of Replacement and Anti-Platelet Therapies in a Patient with Severe Haemophilia A Undergoing Percutaneous Coronary Stent Implantation. (Pubmed Central) - Sep 3, 2022 The results of these indirect treatment comparisons indicate that pharmacokinetics-adjusted, individualized treatment with simoctocog alfa can lead to decreased ABRs and significantly increased zero bleed rates compared with extended half-life concentrates, albeit at a higher weekly dose. Haemophilia A is characterized by frequent haemorrhage.Pharmacokinetic-guided personalized prophylaxis with Nuwiq provided bleeding protection with good tolerability.Nuwiq leads to a reduction of about 20% in both drug consumption and the annualized bleeding rate.
- |||||||||| Wilate (human factor VIII/von Willebrand factor) / Octapharma, Nuwiq (simoctocog alfa) / Octapharma, Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Trial completion date, Trial primary completion date: Protect-NOW: Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients (clinicaltrials.gov) - Jul 8, 2022 P=N/A, N=140, Recruiting, For the treatment of patients with severe Haemophilia-A in Mexico, lonoctocog-alfa was a cost-saving option compared to existing rFVII in Mexico from the public payer perspective. Trial completion date: Jun 2023 --> Jun 2030 | Trial primary completion date: Jun 2023 --> Jun 2030
- |||||||||| Hemlibra (emicizumab-kxwh) / Roche, Eloctate (efraloctocog alfa) / Sanofi, SOBI, Nuwiq (simoctocog alfa) / Octapharma
Hemophilia Registry in a province in nothern Spain (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1958; Of the 66 hemophiliac patients, with age ranging from 3 to 86 (median 35), 92.4% are type A and 7% type B. 50% of the cases are mild; 6.1% are moderate and 43.9% are severe. 45.5% of them receive prophylactic treatment while 54.5% receive it on demand.
- |||||||||| Hemlibra (emicizumab-kxwh) / Roche, Nuwiq (simoctocog alfa) / Octapharma
Enrollment open: Emicizumab PUPs and Nuwiq ITI Study (clinicaltrials.gov) - Nov 5, 2021 P3, N=60, Recruiting, These data allow the interpretation of FVIII activity results for different FVIII products using the Roche FVIII OSA on the cobas t 511/711 analysers. Not yet recruiting --> Recruiting
- |||||||||| pegylated liposome simoctocog alfa (PBB 8 IN) / Ascension Healthcare
Trial completion date, Trial primary completion date: A Pharmacokinetic and Clotting Activity Study of FVIII-PEGLip (clinicaltrials.gov) - Oct 21, 2021 P2, N=20, Recruiting, Planned studies in a larger cohort may confirm our findings. Trial completion date: May 2021 --> May 2022 | Trial primary completion date: Apr 2021 --> Feb 2022
|