Novel interferon-alpha

Abstract

A novel human IFN-α subtype and its derivative having an unprecedentedly high specific activity, DNA encoding these proteins, an expression vector having said DNA, a transformant transformed with said expression vector, a method of producing the above human IFN-α and its derivative, and medical uses of the above human IFN-α and its derivative.

1 . A purified polypeptide comprising an amino acid sequence as set forth in SEQ ID NO: 3 or SEQ ID NO: 4.  
     
     
         2 . A purified polypeptide comprising an amino acid sequence as set forth in SEQ ID NO: 3 or SEQ ID NO: 4, wherein from one to five amino acid residues have been replaced, deleted, and/or added, and wherein the polypeptide has the following characteristics (a) and (b): 
 (a) a specific activity higher than 4.0×108 units/mg in an anti-Sindbis virus assay on cultured FL cells; and    (b) an apparent molecular weight of 20 kDa-23 kDa as determined by sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) after treatment with a reducing agent.    
     
     
         3 . A pharmaceutical composition comprising the polypeptide of  claim 1  or  claim 2 , and a pharmaceutically acceptable carrier or excipient.  
     
     
         4 . The pharmaceutical composition of  claim 3 , which is for treatment of a viral disease.  
     
     
         5 . The pharmaceutical composition of  claim 3 , which is for treatment of cancer.  
     
     
         6 . A method for treating a viral disease in a mammal comprising administering to said mammal in need of treatment an effective amount of the polypeptide of  claim 1  or  2 .  
     
     
         7 . The method of  claim 6 , wherein said mammal is a human.  
     
     
         8 . A method for treating cancer in a mammal comprising administering to said mammal in need of treatment an effective amount of the polypeptide of  claim 1  or  claim 2 .  
     
     
         9 . The method of  claim 8 , wherein said mammal is a human.  
     
     
         10 . A recombinant polypeptide produced by a process comprising: 
 (a) transforming a cell with an expression construct, said expression construct comprising a nucleotide sequence operably linked to a promoter, said nucleotide sequence encoding the polypeptide with an amino acid sequence as set forth in SEQ ID NO: 3 or SEQ ID NO: 4, thereby creating a transformant;    (b) culturing said transformant; and    (c) recovering expressed polypeptide.    
     
     
         11 . A recombinant polypeptide produced by a process comprising: 
 (a) transforming a cell with an expression construct, said expression construct comprising a nucleotide sequence operably linked to a promoter;    said nucleotide sequence encoding the polypeptide with an amino acid sequence as set forth in SEQ ID NO: 3 or SEQ ID NO: 4, wherein from one to five amino acid residues have been replaced, deleted, and/or added, and wherein the polypeptide has the following characteristics (1) and (2):    (1) a specific activity higher than 4.0×108 units/mg in an anti-Sindbis virus assay on cultured FL cells; and    (2) an apparent molecular weight of 20 kDa-23 kDa as determined by sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) after treatment with a reducing agent; thereby creating a transformant;    (b) culturing said transformant; and    (c) recovering expressed polypeptide.    
     
     
         12 . A pharmaceutical composition comprising the recombinant polypeptide of  claim 10  or  claim 11 , and a pharmaceutically acceptable carrier or excipient.  
     
     
         13 . The pharmaceutical composition of  claim 12 , which is for treatment of a viral disease.  
     
     
         14 . The pharmaceutical composition of  claim 12 , which is for treatment of cancer.  
     
     
         15 . A method for treating a viral disease in a mammal comprising administering to said mammal in need of treatment an effective amount of the recombinant polypeptide of  claim 10  or  claim 11 .  
     
     
         16 . The method of  claim 15 , wherein said mammal is a human.  
     
     
         17 . A method for treating cancer in a mammal comprising; administering to said mammal in need of treatment an effective amount of the recombinant polypeptide of  claim 10  or  claim 11 .  
     
     
         18 . The method of  claim 17 , wherein said mammal is a human.