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Rozrolimupab, symphobodies against rhesus D, for the potential prevention of hemolytic disease of the newborn and the treatment of idiopathic thrombocytopenic purpura.

Abstract

Currently under codevelopment by Symphogen and Swedish Orphan Biovitrum, rozrolimupab is the first in a new class of recombinant polyclonal antibodies, known as symphobodies, produced using a proprietary technology from Symphogen. Rozrolimupab is being investigated for the prevention of hemolytic disease of the fetus and newborn (HDFN) and for the treatment of idiopathic thrombocytopenic purpura (ITP). Rozrolimupab comprises 25 genetically unique IgG1 antibodies, all of which are specific for the rhesus D (RhD) erythrocyte protein. In preclinical studies, rozrolimupab demonstrated binding to erythrocytes that was comparable with that of two plasma-derived anti-D Ig preparations. In a phase I clinical trial in healthy male volunteers, treatment with rozrolimupab was not associated with serious adverse events. In a phase II clinical trial of rozrolimupab in healthy, male, RhD-negative volunteers, rozrolimupab dose-dependently cleared RhD-positive erythrocytes from the circulation. Phase II clinical trials in ITP and HDFN are currently ongoing. Phase III clinical trials are necessary to establish the efficacy and safety profile of rozrolimupab compared with standard plasma-derived anti-D Ig preparations.

Links

Authors+Show Affiliations

St George's Hospital, Department of Hematology, Blackshaw Road, Tooting, London, SW17 0QT, UK. roberto.stasi@stgeorges.nhs.uk

Source

MeSH

Antibodies, Monoclonal
Clinical Trials as Topic
Erythroblastosis, Fetal
Erythrocytes
Humans
Immunoglobulin G
Infant, Newborn
Isoantibodies
Protein Binding
Purpura, Thrombocytopenic, Idiopathic
Recombinant Proteins
Rh-Hr Blood-Group System
Rho(D) Immune Globulin

Pub Type(s)

Journal Article

Language

eng

PubMed ID

21154165

Citation

Stasi, Roberto. "Rozrolimupab, Symphobodies Against Rhesus D, for the Potential Prevention of Hemolytic Disease of the Newborn and the Treatment of Idiopathic Thrombocytopenic Purpura." Current Opinion in Molecular Therapeutics, vol. 12, no. 6, 2010, pp. 734-40.
Stasi R. Rozrolimupab, symphobodies against rhesus D, for the potential prevention of hemolytic disease of the newborn and the treatment of idiopathic thrombocytopenic purpura. Curr Opin Mol Ther. 2010;12(6):734-40.
Stasi, R. (2010). Rozrolimupab, symphobodies against rhesus D, for the potential prevention of hemolytic disease of the newborn and the treatment of idiopathic thrombocytopenic purpura. Current Opinion in Molecular Therapeutics, 12(6), pp. 734-40.
Stasi R. Rozrolimupab, Symphobodies Against Rhesus D, for the Potential Prevention of Hemolytic Disease of the Newborn and the Treatment of Idiopathic Thrombocytopenic Purpura. Curr Opin Mol Ther. 2010;12(6):734-40. PubMed PMID: 21154165.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rozrolimupab, symphobodies against rhesus D, for the potential prevention of hemolytic disease of the newborn and the treatment of idiopathic thrombocytopenic purpura. A1 - Stasi,Roberto, PY - 2010/12/15/entrez PY - 2010/12/15/pubmed PY - 2011/5/20/medline SP - 734 EP - 40 JF - Current opinion in molecular therapeutics JO - Curr. Opin. Mol. Ther. VL - 12 IS - 6 N2 - Currently under codevelopment by Symphogen and Swedish Orphan Biovitrum, rozrolimupab is the first in a new class of recombinant polyclonal antibodies, known as symphobodies, produced using a proprietary technology from Symphogen. Rozrolimupab is being investigated for the prevention of hemolytic disease of the fetus and newborn (HDFN) and for the treatment of idiopathic thrombocytopenic purpura (ITP). Rozrolimupab comprises 25 genetically unique IgG1 antibodies, all of which are specific for the rhesus D (RhD) erythrocyte protein. In preclinical studies, rozrolimupab demonstrated binding to erythrocytes that was comparable with that of two plasma-derived anti-D Ig preparations. In a phase I clinical trial in healthy male volunteers, treatment with rozrolimupab was not associated with serious adverse events. In a phase II clinical trial of rozrolimupab in healthy, male, RhD-negative volunteers, rozrolimupab dose-dependently cleared RhD-positive erythrocytes from the circulation. Phase II clinical trials in ITP and HDFN are currently ongoing. Phase III clinical trials are necessary to establish the efficacy and safety profile of rozrolimupab compared with standard plasma-derived anti-D Ig preparations. SN - 2040-3445 UR - https://www.unboundmedicine.com/medline/citation/21154165/Rozrolimupab,_symphobodies_against_rhesus_D,_for_the_potential_prevention_of_hemolytic_disease_of_the_newborn_and_the_treatment_of_idiopathic_thrombocytopenic_purpura L2 - http://www.diseaseinfosearch.org/result/3760 DB - PRIME DP - Unbound Medicine ER -