Granted Patent
B2
US 12,491,232 · App. 18/151,383 · Granted Dec 9, 2025
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
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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 (18)
1 . A method for stimulating regulatory T lymphocytes (Treg) in a human patient, the method comprising administering an interleukin-2 (IL-2) 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, 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.
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 once per day, for at least three consecutive days.
5 . The method of claim 1 , wherein the first course of treatment is followed by the maintenance dose of the IL-2, and wherein the maintenance dose is given to the human patient once every week to every four weeks.
6 . 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.
7 . The method of claim 6 , wherein the first course of treatment comprises administration of IL-2 to the human patient for 4 to 5 days.
8 . The method of claim 1 , wherein the first course of treatment is reproduced at multiple time periods.
9 . The method of claim 8 , wherein every two consecutive time periods in the multiple time periods are interrupted by a period with no treatment.
10 . The method of claim 5 , wherein the maintenance dose starts 1 to 4 weeks after the last dose of the first course of treatment.
11 . The method of claim 5 , wherein the maintenance dose is the same as the dose in the first course of treatment.
12 . 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%.
13 . The method of claim 1 , further comprising measuring stimulation of Treg cells in the human patient.
14 . The method of claim 13 , wherein the measuring step is performed by measuring an increase in Treg counts or an increase in Treg activation markers in the human patient.
15 . The method of claim 13 , wherein the measuring step is performed by measuring the ratio between Treg cells and Teff cells in the human patient.
16 . The method of claim 1 , wherein the human patient has a neurodegenerative disease.
17 . The method of claim 1 , wherein the IL-2 is a human IL-2.
18 . The method of claim 1 , wherein the IL-2 is aldesleukin.
Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 14, 2025
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 070514/0726 →
MERGER AND CHANGE OF NAME
Recorded Mar 14, 2025
From: UNIVERSITE PIERRE ET MARIE CURIE (PARIS 6); SORBONNE UNIVERSITE
To: SORBONNE UNIVERSITE
Reel/Frame 070515/0001 →
Priority Claims (1)
EP 11305269
· Mar 11, 2011
· regional
Continuity (6)
Continuation
14004211
Provisional Application
61451663
· Mar 11, 2011
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