ArmaGen completes primate safety study for AGT-181
SANTA MONICA, CA, USA I September 18, 2009 I ArmaGen has engineered AGT-181, a novel IgG-lysosomal enzyme fusion protein capable of receptor-mediated transport through the human blood-brain barrier (BBB). AGT-181 is formed by fusion of human alpha-L-iduronidase (IDUA) to a genetically engineeered monoclonal antibody (MAb) to the human insulin receptor (HIR). The HIRMAb acts as a molecular Trojan horse to ferry the fused IDUA across the human BBB for the treatment of the brain of patients with Mucopolysaccharidosis (MPS) Type I (Hurler’s syndrome). The FDA has granted Orphan Drug Designation to ArmaGen for AGT-181 treatment of the brain in MPS-I. The fusion protein was manufactured by ArmaGen with methodology that can be replicated in a GMP laboratory, and the study drug was administered to 8 adult Rhesus monkeys in a dose-ranging study. The repeat dosing study showed no toxicity at any of the treatment doses up to 20 mg/kg IV given twice a week. A plasma pharmacokinetics study was performed and immunoreactive AGT-181 was measured with a sandwich 2-site immuno-assay. A second immuno-assay was used to measure the immune response to repeat dosing of the fusion protein, and this showed no significant immune response in primates. The work is published in the Journal of Biotechnology.
SOURCE: ArmaGen Technologies
Post Views: 109
ArmaGen completes primate safety study for AGT-181
SANTA MONICA, CA, USA I September 18, 2009 I ArmaGen has engineered AGT-181, a novel IgG-lysosomal enzyme fusion protein capable of receptor-mediated transport through the human blood-brain barrier (BBB). AGT-181 is formed by fusion of human alpha-L-iduronidase (IDUA) to a genetically engineeered monoclonal antibody (MAb) to the human insulin receptor (HIR). The HIRMAb acts as a molecular Trojan horse to ferry the fused IDUA across the human BBB for the treatment of the brain of patients with Mucopolysaccharidosis (MPS) Type I (Hurler’s syndrome). The FDA has granted Orphan Drug Designation to ArmaGen for AGT-181 treatment of the brain in MPS-I. The fusion protein was manufactured by ArmaGen with methodology that can be replicated in a GMP laboratory, and the study drug was administered to 8 adult Rhesus monkeys in a dose-ranging study. The repeat dosing study showed no toxicity at any of the treatment doses up to 20 mg/kg IV given twice a week. A plasma pharmacokinetics study was performed and immunoreactive AGT-181 was measured with a sandwich 2-site immuno-assay. A second immuno-assay was used to measure the immune response to repeat dosing of the fusion protein, and this showed no significant immune response in primates. The work is published in the Journal of Biotechnology.
SOURCE: ArmaGen Technologies
Post Views: 109
