Long Acting Human Interferon Analogs

Abstract

Compositions, kits and methods are provided for Interferon analogs in order to promote general health or for therapeutic treatment of diseases. Human interferon analogs are made by fusion of interferon with human serum albumin. The bio-assay shows that the interferon analogs with the same cell protection against viral attack have 3-10 times longer acting function than interferon in vivo. These novel long acting interferon analogs can be used in treatment of patients with viral infection, such as SARS virus, HIV, HCV, HBV, or HAV, and the cancer diseases, such as leukemia and malignant melanoma. They also have a 3-5 times longer shelf-life compared with interferon.

1 . A recombinant protein comprising (a) the amino acid sequence of SEQ ID NO: 6; or (b) the amino acid sequence encoded by the polynucleotide of SEQ ID NO: 5. 
     
     
         2 . The recombinant protein of  claim 1 , wherein said protein is a fusion protein of human serum albumin (HSA) and human interferon-β (IFN-β). 
     
     
         3 . The recombinant protein of  claim 2 , wherein said fusion protein has a plasma half-life that is longer than that of IFN-β alone when administered in vivo. 
     
     
         4 . The recombinant protein of  claim 2 , wherein said fusion protein has a shelf-life that is longer than that of IFN-β alone when stored under a same condition. 
     
     
         5 . The recombinant protein of  claim 2 , wherein said fusion protein binds to an antibody of human albumin. 
     
     
         6 . The recombinant protein of  claim 2 , wherein said fusion protein is recombinantly produced in a host cell selected from the group consisting of mammalian and yeast cells. 
     
     
         7 . The recombinant protein of  claim 6 , wherein said yeast cells are selected from the group consisting of  Saccharomyces, Hansenula, Canadida, Pichia, Kluyveromyces, Torulaspora , and  Schinosaccharomyces.    
     
     
         8 . The recombinant protein of  claim 7 , wherein said  Pichia  yeast cells are  Pichia pastoris  cells. 
     
     
         9 . The recombinant protein of  claim 8 , wherein said host cell contains a recombinant vector comprising the polynucleotide of SEQ ID NO: 5. 
     
     
         10 . A composition comprising the recombinant protein of  claim 1 . 
     
     
         11 . The composition of  claim 10  further comprising a second human serum albumin-interferon fusion protein. 
     
     
         12 . The composition of  claim 11 , wherein said second human serum albumin-interferon fusion protein comprises human serum albumin-interferon-α fusion protein, human serum albumin-interferon-γ fusion protein, or human serum albumin-interferon-ω fusion protein. 
     
     
         13 . A kit comprising the recombinant protein of  claim 1  and a second human serum albumin-interferon fusion protein. 
     
     
         14 . The kit of  claim 13 , wherein said second human serum albumin-interferon fusion protein comprises human serum albumin-interferon-α fusion protein, human serum albumin-interferon-γ fusion protein, or human serum albumin-interferon-ω fusion protein.