EXTENDED RELEASE OF NEUREGULIN FOR TREATING HEART FAILURE

• US 20160089329A1
• Filed: 05/22/2014
• Published: 03/31/2016
• Est. Priority Date: 05/22/2013
• Status: Active Grant

• Current Assignee: Zensun (Shanghai) Science & Technology, Co., Ltd.
• Original Assignee: Zensun (Shanghai) Science & Technology Limited
• Inventors: ZHOU, Mingdong
• Granted Patent: US 10,098,834 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 38/1883 Neuregulins, e.g.. p185erbB2 ligands, glial growth factor, heregulin, ARIA, neu differentiation factor
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/04 Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure

Abstract

The present invention provides methods and kits for preventing, treating or delaying various cardiovascular diseases or disorders especially heart failure by extended release of neuregulin to a mammal. Moreover, the extended release of neuregulin is administered by subcutaneous infusion with a pump.

Claims

1. A method for preventing, treating or delaying a cardiovascular disease or disorder in a mammal, the method comprising subcutaneous extended release of neuregulin into a mammal in an amount of 0.3 μ

g/kg/day to 3.0 μ

g/kg/day, wherein the subcutaneous extended release of neuregulin into a mammal is accomplished through the use of a pump.

2. The method of claim 1, wherein the disease or disorder is heart failure.

3. The method of claim 1, wherein the mammal is human.

4. The method of claim 1, wherein the subcutaneous extended release of neuregulin into a mammal is accomplished through the use of a syringe pump.

5. The method of claim 4, wherein the syringe pump is a mini pump.

6. The method of claim 5, wherein the mini pump is an insulin pump.

7. The method of claim 1, wherein neuregulin is in an amount of 1.2 μ

g/kg/day to 2.0 μ

g/kg/day.

8. The method of claim 1, wherein neuregulin is in an amount of 1.2 μ

g/kg/day.

9. The method of claim 1, wherein neuregulin is in an amount of 2.0 μ

g/kg/day.

10. The method of claim 1, wherein neuregulin is in an amount of 6 EU/kg/day to 60 EU/kg/day.

11. The method of claim 1, wherein neuregulin is in an amount of 24 EU/kg/day to 40 EU/kg/day.

12. The method of claim 1, wherein neuregulin is in an amount of 24 EU/kg/day.

13. The method of claim 1, wherein neuregulin is in an amount of 40 EU/kg/day.

14. The method of claim 1, wherein the neuregulin is administered to the mammal for an induction regimen.

15. The method of claim 14, wherein the induction regimen includes an administration of neuregulin for at least 3, 5, 7, 10 or 15 consecutive days.

16. The method of claim 14, wherein the induction regimen includes an administration of neuregulin for 10 consecutive days.

17. The method of claim 14, wherein the neuregulin is administered for at least 2, 4, 6, 8, 10, 12, 16, 20, 24 consecutive hours every day.

18. The method of claim 14, wherein the neuregulin is administered for 8 consecutive hours every day.

19. The method of claim 14, wherein the neuregulin is administered to the patients for a maintenance regimen after the induction regimen.

20. The method of claim 19, wherein the maintenance regimen includes an administration of neuregulin for at least 3 months, 6 months, 12 months, 5 years or even longer after the induction regimen.

21. The method of claim 19, wherein the maintenance regimen includes a repeat of the induction regimen every 3 months, 6 months or 12 months.

22. The method of claim 1, wherein the extended release of neuregulin into a mammal enhances the ejection fraction (EF) value of the mammal.

23. The method of claim 1, wherein the extended release of neuregulin into a mammal reduces the Left Ventricular End-Diastolic Volume (LVEDV) of the mammal.

24. The method of claim 1, wherein the extended release of neuregulin into a mammal reduces the Left Ventricular End-Systolic Volume (LVESV) of the mammal.

25. The method of claim 1, wherein the extended release of neuregulin into a mammal improves 6 Minute Walk Distance (6 MWD) of the mammal.

26. The method of claim 1, wherein the extended release of neuregulin into a mammal improves quality of life of the mammal.

27. A kit for preventing, treating or delaying a cardiovascular disease or disorder in a mammal, the kit comprising a neuregulin composition or formulation and a pump.

28. The kit of claim 27, wherein the disease or disorder is heart failure.

29. The kit of claim 27, wherein the mammal is human.

30. The kit of claim 27, wherein the pump is a syringe pump.

31. The kit of claim 27, wherein the pump is a mini pump.

32. The kit of claim 27, wherein the pump is an insulin pump.