SIALYLATED GLYCOPROTEIN COMPOSITONS AND USES THEREOF
The present application relates to sialylated glycoprotein compositions and methods of their use in treating various conditions and disorders.
1 - 27 . (canceled)
28 . A method for treating mucopolysaccharidosis type 7, comprising administering a recombinant β-glucuronidase, wherein the recombinant β-glucuronidase is administered at a dose of 0.5 mg/kg to 12 mg/kg, and wherein the recombinant β-glucuronidase has a sialylation content of at least 0.7 mol/mol of the recombinant β-glucuronidase.
29 . The method of claim 28 , wherein the recombinant glycoprotein has a sialylation content of at least 1 mol/mol and a level of M6P moieties of at least 10 mol % of the total glycan of the recombinant glycoprotein.
30 . The method of claim 28 , wherein the recombinant β-glucuronidase is administered at a dose of at least about 0.5 mg/kg.
31 . The method of claim 28 , wherein the recombinant β-glucuronidase is administered at a dose of at about 1 mg/kg to about 8 mg/kg.
32 . The method of claim 28 , wherein the recombinant β-glucuronidase is administered at a dose of at about 2 mg/kg to about 6 mg/kg.
33 . The method of claim 28 , wherein the recombinant β-glucuronidase is administered at a dose of at about 4 mg/kg.
34 . The method of claim 28 , wherein the recombinant β-glucuronidase is administered weekly.
35 . The method of claim 28 , wherein the recombinant β-glucuronidase is administered every other week.
36 . The method of claim 28 , wherein the recombinant β-glucuronidase is administered intravenously.
37 . The method of claim 28 , wherein the recombinant β-glucuronidase is administered by continuous infusion.
38 . The method of claim 28 , wherein the regimen of recombinant β-glucuronidase is administered concurrently with or following antihistamine therapy.
39 . The method of claim 28 , wherein the recombinant β-glucuronidase is administered to a human.
40 . The method of claim 28 , wherein the recombinant β-glucuronidase has a sialylation content of about 0.8 mol/mol.
41 . The method of claim 28 , wherein the recombinant β-glucuronidase has a sialylation content of about 1.0 mol/mol.
42 . The method of claim 28 , wherein the recombinant β-glucuronidase has a sialylation content of about 1.2 mol/mol.
43 . The method of claim 28 , wherein the recombinant β-glucuronidase has a sialylation content of about 1.0 mol/mol to about 1.2 mol/mol.
44 . The method of claim 28 , wherein the recombinant β-glucuronidase is human recombinant β-glucuronidase.
45 . The method of claim 28 , wherein the recombinant β-glucuronidase comprises SEQ ID NO: 1.
46 . The method of claim 28 , wherein the recombinant β-glucuronidase consists of SEQ ID NO: 1.