Sialylated glycoprotein compositons and uses thereof

Abstract

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.