IP Library Granted Patent US 11,559,566
Granted Patent B2
US 11,559,566 · App. 16/925,983 · Granted Jan 24, 2023

Use of low dose IL-2 for treating autoimmune-related or inflammatory disorders

Inventors: David Klatzmann (Paris, FR); David Saadoun (Neuilly sur Seine, FR); Patrice Cacoub (Le Perreux, FR); Michèle Rosenzwajg (Paris, FR); Eliane Piaggio (Paris, FR); Gilbert Bensimon (Villejuif, FR); Claude Bernard (Malakoff, FR)
Assignees: INSERM (Institut National de la Sante et de la Recherche Medicale); ASSISTANCE PUBLIQUE HOPITAUX DE PARIS; SORBONNE UNIVERSITE
A61K38/2013
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Quick Facts
Patent No.
US 11,559,566
App. No.
16/925,983
Granted
Jan 24, 2023
Kind
B2
Abstract

The present invention relates to novel therapies for treating autoimmune and inflammatory diseases. More specifically, the present invention relates to a use of low dose interleukin-2 for the treatment of type I diabetes and other autoimmune and/or inflammatory diseases.

Claims (16)

1. A method for stimulating regulatory T lymphocytes (Treg) in a human patient, the method comprising administering an interleukin-2 (IL2) to a human patient in need thereof at a dose of between 0.1 and 3.5 MIU/day in a first course of treatment, which comprises administration of the IL-2 once per day for at least three consecutive days, wherein the first course of treatment increases Treg cells in the subject; and wherein the first course of treatment is followed by a maintenance dose of the IL-2, and wherein the maintenance dose is given to the human patient once every week to every four weeks.

2. The method of claim 1 , wherein the dose of IL-2 in the first course of treatment is between 1.5 to 3 MIU/day.

3. The method of claim 2 , wherein the dose of IL-2 in the first course of treatment is 2 MIU/day.

4. The method of claim 1 , wherein the first course of treatment comprises administration of the IL-2 to the human patient for 3 to 7 days.

5. The method of claim 4 , wherein the first course of treatment comprises administration of IL-2 to the human patient for 4 to 5 days.

6. The method of claim 1 , wherein the first course of treatment is reproduced at multiple time periods.

7. The method of claim 6 , wherein every two consecutive time periods in the multiple time periods are interrupted by a period with no treatment.

8. The method of claim 1 , wherein the maintenance dose starts 1 to 4 weeks after the last dose of the first course of treatment.

9. The method of claim 1 , wherein the maintenance dose is the same as the dose in the first course of treatment.

10. The method of claim 1 , wherein the first course of treatment increases the ratio of Tregs to effector T (Teff) cells by at least 20%.

11. The method of claim 1 , further comprising assessing increase of Treg cells in the human patient.

12. The method of claim 11 , wherein the assessing step is performed by measuring the level of Treg cells in the human patient.

13. The method of claim 11 , wherein the assessing step is performed by measuring the ratio between Treg cells and Teff cells.

14. The method of claim 1 , wherein the human patient has a neurodegenerative disease.

15. The method of claim 1 , wherein the IL-2 is a human IL-2.

16. The method of claim 1 , wherein the IL-2 is aldesleukin.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 13, 2022
From: KLATZMANN, DAVID; SAADOUN, DAVID; CACOUB, PATRICE; ROSENZWAJG, MICHÈLE; PIAGGIO, ELIANE; BENSIMON, GILBERT; BERNARD, CLAUDE
To: INSERM (INSTITUT NATIONAL DE LA SANTÉ ET DE LA RECHERCHE MÉDICALE); ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS; UNIVERSITE PIERRE ET MARIE CURIE (PARIS 6)
Reel/Frame 063481/0269 →
MERGER AND CHANGE OF NAME Recorded Dec 13, 2022
From: UNIVERSITE PIERRE ET MARIE CURIE (PARIS 6); SORBONNE UNIVERSITÉ
To: SORBONNE UNIVERSITÉ
Reel/Frame 063775/0500 →
Priority Claims (1)
EP 1305269 · Mar 11, 2011 · regional
Continuity (5)
Continuation 16361902 · Mar 22, 2019
Continuation 15588226 · May 5, 2017
Continuation 14004211
Provisional Application 61451663 · Mar 11, 2011
Related Publication 20210038691A1 · Feb 11, 2021
Cited By (1)
US 12,491,232