Methods of using interleukin-10 for treating diseases and disorders

Abstract

Methods of treating subjects having a disease or disorder responsive to IL-10, including methods of administration and dosing regimens associated therewith, are provided.

1 - 99 . (canceled) 
     
     
         100 . A method of treating a solid tumor in a human subject, comprising:
 administering to a human subject a PEG-IL-10 agent at 5-20 μg/kg daily by parenteral injection,
 wherein the PEG-IL-10 agent comprises amino acid residues 19-178 of SEQ ID NO: 29, 
 wherein the PEG-IL-10 agent is a mixture of mono-pegylated and di-pegylated IL-10, 
 and wherein the PEG component of the PEG-IL-10 agent has a molecular mass of about 5 kDa, and the PEG component is covalently attached to the alpha amino group of the amino acid residue at the N-terminus of IL-10. 
   
     
     
         101 . The method of  claim 100 , wherein the parenteral injection is a subcutaneous injection. 
     
     
         102 . The method of  claim 100 , wherein the solid tumor is colon cancer, ovarian cancer, breast cancer, melanoma, lung cancer, pancreatic cancer, or kidney cancer. 
     
     
         103 . The method of  claim 101  or  102 , wherein the mixture of mono-pegylated and di-pegylated IL-10 is in a ratio of 1:1. 
     
     
         104 . The method of  claim 103 , wherein the amount of the PEG-IL-10 agent administered is 5 μg/kg. 
     
     
         105 . The method of  claim 103 , wherein the amount of the PEG-IL-10 agent administered is 10 μg/kg. 
     
     
         106 . The method of  claim 103 , wherein the amount of the PEG-IL-10 agent administered is 20 μg/kg. 
     
     
         107 . The method of  claim 103 , wherein the PEG-IL-10 agent is administered in combination with 5-fluorouracil, folinic acid, and a platinum coordination complex.