AryoSeven (eptacog alfa biosimilar) / AryoGen Pharmed - LARVOL DELTA

Comparative Efficacy of Recombinant FVIII and Recombinant FVII Biosimilars in Severe Hemophilia A. (PubMed, Clin Appl Thromb Hemost) - "The only possible treatment for this bleeding condition is factor concentrate.AimThe aim of this study is to compare the effect of recombinant factor VIII (rFVIII) and recombinant factor VII (rFVII) on prothrombin time (PT), activated partial thromboplastin time (aPTT), FVIII and FVII in severe HA.MethodologyA mixing study was conducted on 30 samples of severe HA patients to assess the correction of PT, aPTT, FVIII, and FVII values using biosimilars of rFVIII (NovoEight and Kogenate FS) and rFVII (NovoSeven and AryoSeven) using a fully automated coagulation analyser 'Ceveron alpha'.ResultsAll the four drugs demonstrated a significant alteration for both PT (P < .0001) and aPTT (P < .0001) values. Two different groups of biosimilars were found to have a high potential to alter the PT and aPTT values. The FVIII biosimilars are efficient in increasing the FVIII levels."

Clinical • Journal • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

The Influence of Coagulation Factor Biosimilars in Shortening the Activated Partial Thromboplastin Time in Patients with Hemophilia a (ASH 2024) - "Negative correlation was observed between PT and FVII values after adding Kogenate FS (r=-0.103, p<0.001), aPTT and FVIII values after adding Kogenate FS (r=-0.898, p<0.001), aPTT and FVIII values after adding NovoEight (r=-0.865, p<0.001), as well as aPTT and FVIII values after adding AryoSeven (r=-0.647, p<0.001).Conclusion : All the investigated drugs significantly shorten aPTT values and increase values of FVIII and FVII. In terms of efficacy, no difference exists between AryoSeven and NovoSeven, as well as between Kogenate FS and NovoEight only in altering PT."

Clinical • Genetic Disorders • Hematological Disorders • Hemophilia • Hemophilia A • Mood Disorders • Rare Diseases

Evaluation of Coagulation Factor VII Biosimilars (AryoSeven Vs NovoSeven) in Modulating Prothrombin Time, activated Partial Thromboplastin Time, and levels of Factors VII and VIII in Hemophilia A (ISTH 2024) - "In a comparison of both of the investigational drugs to the original values of PT, aPTT, FVII, and FVIII, among-group comparison with post-hoc pairwise comparisons showed a high statistically significant difference in values of all four parameters, compared to pre-treatment values (Table 1). No difference was observed between the values of all four investigated parameters after adding AryoSeven and NovoSeven. A negative correlation was observed between aPTT and FVIII values after adding AryoSeven (r=-0.647, p< 0.001)."

Hematological Disorders • Hemophilia • Rare Diseases

Bioequivalence of a Generic Version of rFVIIa (Aryoseven) as Compared to the Branded Version of rFVIIa (Novoseven). (ISTH 2023) - "The results of the various tests comparing the two versions of recombinant Factor VIIa are shown in table 1. The two FVIIa preparations also produced comparable effects in the plasma samples with elevated PT and aPTT. The FVII antigen levels was comparable in both preparations."

Hepatology

OVERCOMING HIGH TITER INHIBITOR OF FVII IN AN INFANT WITH CONGENITAL FACTOR VII FOR PLACEMENT OF PORT-A-CATH WITH CONTINUOUS INFUSION OF RECOMBINANT ACTIVATED FACTOR VII (EAHAD 2023) - "During admission, multiple doses of rFVIIa (AryoSeven™) (90-270 μg/kg) in different intervals were administered; however, normal PT was not achieved to be prepared for the surgery... It could be suggested that administration of rFVIIa by continuous infusion is a safe and convenient alternative to bolus injections in infants with inhibitors who are going to undergo surgical procedures."

CNS Disorders • Epilepsy • Hematological Disorders • Hemophilia • Rare Diseases • Ventriculomegaly

A Generic Version of rFVIIa Is Bioequivalent to the Branded Version of rFVIIa (ASH 2022) - "The molecular characteristics of Aryoseven are comparable to Novoseven. These studies demonstrate that the two versions of FVIIa are comparable. Furthermore, these results warrant additional validation in animal models and clinical trials."

Hematological Disorders • Hemophilia • Hepatology • Rare Diseases • Thrombocytopenia • Thrombocytopenic Purpura

Study on the Dose-response Relationship of Pharmacodynamic Parameters in Patients With Hemophilia With Inhibitors (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: AryoGen Pharmed Co. | Recruiting ➔ Completed

Trial completion • Hematological Disorders • Hemophilia • Rare Diseases

Prospective, Non-interventional Study to Evaluate Immunogenicity of AryoSeven (clinicaltrials.gov) - P=N/A | N=200 | Completed | Sponsor: AryoGen Pharmed Co. | Enrolling by invitation ➔ Completed

Trial completion • Hematological Disorders • Hemophilia • Rare Diseases

Study on the Dose-response Relationship of Pharmacodynamic Parameters in Patients With Hemophilia With Inhibitors (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: AryoGen Pharmed Co. | Trial completion date: Jul 2021 ➔ Jul 2022 | Trial primary completion date: Apr 2021 ➔ May 2022

Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Rare Diseases

Study on the Dose-response Relationship of Pharmacodynamic Parameters in Patients With Hemophilia With Inhibitors (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: AryoGen Pharmed Co.

Clinical • New P1 trial • Hematological Disorders • Hemophilia • Rare Diseases

Clinical Trial Comparing a Biosimilar Eptacog Alfa With Novoseven, in Patients With Hemophilia With Inhibitors (clinicaltrials.gov) - P3; N=48; Completed; Sponsor: AryoGen Pharmed Co.; Recruiting ➔ Completed

Clinical • Trial completion • Hematological Disorders • Hemophilia • Rare Diseases

Prospective, Non-interventional Study to Evaluate Immunogenicity of AryoSeven (clinicaltrials.gov) - P=N/A; N=200; Enrolling by invitation; Sponsor: AryoGen Pharmed Co.; Trial completion date: Nov 2020 ➔ Apr 2021; Trial primary completion date: Oct 2020 ➔ Mar 2021

Clinical • Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Rare Diseases

Clinical Trial Comparing a Biosimilar Eptacog Alfa With Novoseven, in Patients With Hemophilia With Inhibitors (clinicaltrials.gov) - P3; N=48; Recruiting; Sponsor: AryoGen Pharmed Co.; Trial completion date: Nov 2020 ➔ Feb 2021; Trial primary completion date: Oct 2020 ➔ Jan 2021

Clinical • Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Rare Diseases

[VIRTUAL] Inhibitor Development in Patients with Type 3 von Willebrand Disease, a Comprehensive Study on a Large Number of Iranian Patients (ISTH 2020) - "Before inhibitor formation, the majority of the patients (94%) received on demand regimen (Haemate®, CSL Behring, Marburg, Germany), while one patient received a prophylactic regimen (Wilate®, Octapharma, Lachen, Switzerland). Inhibitor formation can significantly exacerbate the clinical presentations, therefore, early detection of major risk factors of inhibitor formation should be considered as a preventative program."

Clinical • Allergy

[VIRTUAL] A Generic Recombinant Factor VIIa Is Comparable to the Branded Novoseven in In-vitro and Pharmacokinetic Studies in Primates (ISTH 2020) - "The pharmacokinetic profile of the NovoSeven® and AryoSeven™ as studied in primates by measuring the factor VIIa level for up to 4 hours post-administration were found to be comparable. These results support the hypothesis that NovoSeven® and AryoSeven™ are biosimilar. Further clinical validation studies are warranted."

PK/PD data • Preclinical • Gene Therapies • Hematological Disorders • Hemophilia • Rare Diseases • F2

[VIRTUAL] Congenital Combined Bleeding Disorders, a Study on a Large Number of Iranian Patients (ISTH 2020) - "The first one was a 4 years old boy who experienced recurrent ICH and received prophylaxis regimen with AryoSevenTM (AryoGen, Tehran, Iran) in a dose of 30 µg/kg/a day... The coinheritence of bleeding disorders in Iran is surprisingly higher than expected."

Clinical • Gastroenterology • Gene Therapies • Hematological Disorders • Hemophilia • Rare Diseases

Clinical Trial Comparing a Biosimilar Eptacog Alfa With Novoseven, in Patients With Hemophilia With Inhibitors (clinicaltrials.gov) - P3; N=48; Recruiting; Sponsor: AryoGen Pharmed Co.; Trial primary completion date: Jun 2020 ➔ Oct 2020

Clinical • Trial primary completion date • Gene Therapies • Hematological Disorders • Hemophilia • Rare Diseases • F2

Prospective, Non-interventional Study to Evaluate Immunogenicity of AryoSeven (clinicaltrials.gov) - P=N/A; N=200; Enrolling by invitation; Sponsor: AryoGen Pharmed Co.; Trial completion date: Dec 2018 ➔ Nov 2020; Trial primary completion date: Dec 2018 ➔ Oct 2020

Clinical • Trial completion date • Trial primary completion date • Gene Therapies • Hematological Disorders • Hemophilia • Rare Diseases

Clinical Trial Comparing a Biosimilar Eptacog Alfa With Novoseven, in Patients With Hemophilia With Inhibitors (clinicaltrials.gov) - P3; N=48; Recruiting; Sponsor: AryoGen Pharmed Co.; Trial primary completion date: Nov 2019 ➔ Jun 2020

Clinical • Trial primary completion date • F2

Clinical Trial Comparing a Biosimilar Eptacog Alfa With Novoseven, in Patients With Hemophilia With Inhibitors (clinicaltrials.gov) - P3; N=48; Recruiting; Sponsor: AryoGen Pharmed Co.

Clinical • New P3 trial