Methods for Lowering Elevated Uric Acid Levels Using Intravenous Injections of PEG-Uricase

• US 20070274977A1
• Filed: 10/06/2006
• Published: 11/29/2007
• Est. Priority Date: 04/11/2005
• Status: Active Grant

• Current Assignee: Horizon Therapeutics USA, Inc. (Amgen Inc.), Duke University
• Original Assignee: Duke University
• Inventors: Hartman, Jacob, Mendelovitz, Simona, Huang, William, Hershfield, Michael, Dehrig, Claudia
• Granted Patent: US 8,148,123 B2
• Time in Patent Office: Days
• US Class Current: 424/94.400
• CPC Class Codes: A61K 38/44 Oxidoreductases (1)
• CPC Class Codes: A61K 47/60 the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
• CPC Class Codes: A61P 19/06 Antigout agents, e.g. antihyperuricemic or uricosuric agents
• CPC Class Codes: C12Y 107/03003 Factor-independent urate hydroxylase (1.7.3.3), i.e. uricase

Abstract

A method for lowering elevated uric acid levels in patients is disclosed and consists of administering to the patients an intravenous injection of PEG-uricase having a dosage from about 4 to about 12 mg.

Claims

1. A method for lowering elevated uric acid levels in a patient comprising administering to said patient an intravenous injection of PEG-uricase having a dosage from about 4 to about 12 mg.

2. The method of claim 1, wherein said dosage is between 4 and 8 mg.

3. The method of claim 1, wherein said dosage is between 8 and 12 mg.

4. The method of claim 1, wherein said dosage is about 4 mg.

5. The method of claim 1, wherein said patient is suffering from gout.

6. The method of claim 5, wherein said gout is refractory.

7. The method of claim 1, wherein said gout is chronic or tophaceous.

8. The method of claim 1, wherein said administration takes place from about every 2 to 4 weeks.

9. The method of claim 1, wherein said patient has a plasma level of uric acid (pUAc) of more than about 6 mg/dL before said administration.

10. A method for lowering elevated uric acid levels in a patient comprising administering to said patient an intravenous injection of PEG-uricase having a dosage from about 0.5 to about 12 mg, wherein said PEG-uricase comprises a mammalian uricase amino acid sequence truncated at the amino terminus or the carboxy terminus or both the amino and carboxy termini by about 1-13 amino acids.

11. The method of claim 10, wherein said said truncated amino acid sequence further comprises an amino terminal amino acid, wherein the amino terminal amino acid is selected from the group consisting of alanine, glycine, proline, serine and threonine.

12. The method of claim 10, wherein said dosage is between 4 and 8 mg.

13. The method of claim 10, wherein said dosage is between 8 and 12 mg.

14. The method of claim 10, wherein said dosage is about 4 mg.

15. The method of claim 10, wherein said patient is suffering from gout.

16. The method of claim 15, wherein said gout is refractory.

17. The method of claim 15, wherein said gout is chronic or tophaceous.

18. The method of claim 10, wherein said administration takes place from about every 2 to 4 weeks.

19. The method of claim 10, wherein said patient has a plasma level of uric acid (pUAc) of more than about 6 mg/dL before said administration.