Methods of treating using hormone-albumin fusion proteins
Biologically active polypeptides comprising a therapeutically active polypeptide fused to human serum albumin or a variant of human serum albumin, methods for preparation, nucleotide sequences encoding such fusion polypeptides, expression cassettes comprising such nucleotide sequences, self-replicating plasmids containing such expression cassettes, and pharmaceutical compositions containing fusion polypeptides.
1. A method of treating a patient in need of a hormone, comprising the step of administering to said patient a fusion protein comprising hormone and albumin or an albumin variant, wherein (i) said fusion protein has a higher plasma stability than the unfused hormone, (ii) said albumin or albumin variant is located either at the N-terminus or C-terminus of said fusion protein, and (iii) said fusion protein retains the therapeutic activity of the unfused hormone.
2. The method of claim 1 , wherein said fusion protein comprises albumin.
3. The method of claim 1 , wherein said fusion protein comprises an albumin variant.
4. The method of claim 3 , wherein said albumin variant is a fragment of albumin.
5. The method of claim 3 , wherein said albumin variant has a mutation of one or more residues.
6. The method of claim 3 , wherein said albumin variant has a deletion of one or more residues.
7. The method of claim 3 , wherein said albumin variant has a mutation and a deletion of one or more residues.
8. The method of claim 3 , wherein said albumin variant has an addition of one or more residues.
9. The method of claim 1 , wherein said fusion protein comprises an N-terminal methionine.
10. The method of claim 1 , wherein said fusion protein comprises a peptide linker.
11. The method of claim 1 , wherein said hormone is fused to the N-terminal end of said albumin or albumin variant.
12. The method of claim 1 , wherein said hormone is fused to the C-terminal end of said albumin or albumin variant.
13. A method of treating a patient in need of a hormone, comprising the step of administering to said patient a fusion protein comprising hormone and a mature form of albumin, wherein (i) said fusion protein has a higher plasma stability than the unfused hormone, (ii) said mature form of albumin is located either at the N-terminus or C-terminus of said fusion protein, and (iii) said fusion protein retains the therapeutic activity of the unfused hormone.
14. The method of claim 13 , wherein said fusion protein comprises an N-terminal methionine.
15. The method of claim 13 , wherein said fusion protein comprises a peptide linker.
16. The method of claim 13 , wherein said hormone is fused to the N-terminal end of said mature form of albumin.
17. The method of claim 16 , wherein said fusion protein comprises an N-terminal methionine.
18. The method of claim 16 , wherein said fusion protein comprises a peptide linker.
19. The method of claim 13 , wherein said hormone is fused to the C-terminal end of said mature form of albumin.
20. The method of claim 19 , wherein said fusion protein comprises an N-terminal methionine.
21. The method of claim 19 , wherein said fusion protein comprises a peptide linker.
22. The method of claim 1 , wherein said hormone is human hormone, and said albumin or an albumin variant is human albumin or a human albumin variant.
23. The method of claim 13 , wherein said hormone is human hormone, and said mature form of albumin is mature form of human albumin.