IP Library Granted Patent US 9,375,411
Granted Patent B2
US 9,375,411 · App. 14/653,807 · Granted Jun 28, 2016

Uses and methods for the treatment of liver diseases or conditions

Inventors: François Ravenelle (Montréal, CA); Pierre Falardeau (Westmount, CA); Patrick Colin (St-Bruno de Montarville, CA)
Assignee: Verlyx Pharma Inc.
A61K31/155A61K9/0053A61K31/10A61K31/185A61K45/06
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 9,375,411
App. No.
14/653,807
Granted
Jun 28, 2016
Kind
B2
Abstract

The present application relates methods and uses of oral diamidines or pharmaceutically acceptable salts thereof for the treatment of liver diseases or conditions.

Claims (28)

1. A method for the palliative or restorative targeted treatment of one or more liver conditions comprising the step of orally administering a therapeutically effective amount of at least one diamidine analogue to a human patient in need thereof; wherein the liver condition is liver cancer, liver metastasis, high cholesterol, alcoholic liver disease, cirrhosis, cysts, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), fibrosis, jaundice, primary sclerosing cholangitis (PSC), hemochromatosis, primary biliary cirrhosis or Alpha-1 Antitrypsin Deficiency, wherein the diamidine analogue is pentamidine or decamidine or a pharmaceutically acceptable salt thereof.

2. The method of claim 1 , wherein the levels of the diamidine analogue are increased in the liver relative to the levels in other tissues or organs.

3. The method of claim 1 , wherein the diamidine analogue is pentamidine or a pharmaceutically acceptable salt thereof.

4. The method of claim 1 , wherein the diamidine analogue is decamidine or a pharmaceutically acceptable salt thereof.

5. The method of claim 1 , wherein the diamidine analogue is pentamidine bis(2-hydroxyethanesulfonate), pentamidine isethionate, pentamidine HCl or pentamidine tosylate.

6. The method of claim 1 , wherein the diamidine analogue is pentamidine isethionate.

7. The method of claim 1 , wherein the diamidine analogue is administered at least once daily at a dose of about 1 mg to about 3000 mg, of about 1 mg to about 2000 mg or of about 50 mg to about 700 mg.

8. The method of claim 1 , wherein the diamidine analogue is administered for more than 15, 60, 120 or 365 consecutive days.

9. The method of claim 1 , wherein the diamidine analogue is orally administered as a solid dosage form or as an instant release solid dosage form.

10. The method of claim 1 , wherein the treatment results in a reduced toxicity relative to an equivalent diamidine analogue dose administered intravenously.

11. The method of claim 1 , wherein the treatment results in a reduced kidney, heart or pancreas toxicity relative to an equivalent diamidine analogue dose administered intravenously.

12. The method of claim 1 , wherein the liver cancer is intra-hepatic bile duct cancer or hepatocarcinoma.

13. The method of claim 1 , wherein the liver metastases are liver dominant cancer metastases or liver limited cancer metastases.

14. The method of claim 1 , wherein the liver condition is alcoholic liver disease.

15. The method of claim 1 , wherein the liver condition is primary biliary cirrhosis.

16. The method of claim 1 , wherein the liver condition is NAFLD.

17. The method of claim 1 , wherein the liver condition is Alpha-1 Antitrypsin Deficiency.

18. The method of claim 1 , wherein the liver condition is primary sclerosing cholangitis (PSC).

19. The method of claim 1 , wherein the diamidine analogue is administered in combination with a further agent indicated for the treatment of the one or more liver conditions.

20. The method of claim 14 , wherein the alcoholic liver disease is alcoholic hepatitis.

21. The method of claim 14 , wherein the alcoholic liver disease is acute alcoholic hepatitis.

22. The method of claim 1 , wherein the liver condition is NASH.

23. A method for the palliative or restorative targeted treatment of non-alcoholic fatty liver disease (NAFLD) comprising the step of orally administering a therapeutically effective amount of pentamidine or a pharmaceutically acceptable salt thereof.

24. The method of claim 23 , wherein pentamidine or a pharmaceutically acceptable salt thereof is pentamidine isethionate.

25. The method of claim 23 , wherein the treatment results in a reduced toxicity relative to an equivalent pentamidine dose administered intravenously.

26. A method for the palliative or restorative targeted treatment of non-alcoholic steatohepatitis (NASH) comprising the step of orally administering a therapeutically effective amount of pentamidine or a pharmaceutically acceptable salt thereof.

27. The method of claim 26 , wherein pentamidine or a pharmaceutically acceptable salt thereof is pentamidine isethionate.

28. The method of claim 26 , wherein the treatment results in a reduced toxicity relative to an equivalent pentamidine dose administered intravenously.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 21, 2015
From: RAVENELLE, FRANCOIS; FALARDEAU, PIERRE; COLIN, PATRICK
To: ONCOZYME PHARMA INC.
Reel/Frame 036391/0205 →
CHANGE OF NAME Recorded Aug 21, 2015
From: ONCOZYME PHARMA INC.
To: VERLYX PHARMA INC.
Reel/Frame 036420/0137 →
Continuity (2)
Provisional Application 61745011 · Dec 21, 2012
Related Publication 20150297540A1 · Oct 22, 2015