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

An autoimmune disease and immune-related technology, which is applied in the application field of low-dose IL-2 for the treatment of autoimmune-related diseases or inflammatory diseases, and can solve problems such as exacerbation of diseases

Inactive Publication Date: 2014-04-16
公共事业救济局-巴黎医院 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Indeed, the ability of IL-2 to stimulate Teff carries the risk of exacerbating the disease by activating the very effector T cells that mediate the disease

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0223] Example 1: Low Dose IL-2 in HCV-Associated Vasculitis

[0224] Here, we provide the first evidence in human subjects that IL-2 can be used to induce Tregs without inducing Teffs in patients with autoimmunity. Here we report the first demonstration of in vivo expansion of very potent suppressive Tregs by IL-2 immunotherapy in human autoimmune diseases, leading to clinical improvement. The primary endpoint of our study, increased Treg at the end of IL-2 therapy, was met as well as all secondary priorities, including clinical response. We show that low-dose IL-2 is well tolerated, induces a sharp and selective increase in Treg cells, and leads to clinical improvement in 80% of patients. This is the first demonstration of Treg induction and recovery in vivo following IL-2 immunotherapy in a human autoimmune disease. Furthermore, we show for the first time a significant anti-inflammatory effect of low-dose IL-2 in humans.

[0225] method

[0226] patient

[0227] Incl...

Embodiment 2

[0272] Example 2: Low Dose IL-2 in Type 1 Diabetes Mellitus

[0273] The present inventors initiated an IL-2 dose-finding clinical trial in T1D, which aimed to determine the lowest active dose capable of safely inducing Tregs in adult T1D patients.

[0274] The DF-IL2 trial was double-blind and compared placebo, 0.3, 1 and 3mIU / day Dose (cumulative doses were 1.5, 5 and 15mIU).

[0275] The aim of the trial was to preserve residual endogenous insulin secretion in newly diagnosed T1D patients.

[0276] Key patient characteristics: adult, both sexes, T1D diagnosis per WHO-ADA, disease duration less than 12 weeks from diagnosis at first IL-2 dose, and C-peptide available at entry detection.

[0277] To achieve a clinically meaningful effect, the currently recommended goal is to preserve at least the pancreatic β-cell mass with active therapy, ie maintain an AUC of C-peptide relative to baseline of 0-120.

[0278] All 24 patients were included. Although investigators remain ...

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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.

Description

technical field [0001] The present invention relates to novel IL-2 based therapies for human diseases. More specifically, the invention relates to low dose IL-2 therapy in human subjects for autoimmune, immune-related or inflammatory diseases, including inflammation. Background technique [0002] Interleukin-2 (IL-2) was identified almost 30 years ago [1] and was originally called a T-cell growth factor due to its ability to stimulate T lymphocytes in vitro. It is a protein with a reported molecular weight between about 13 kda and 17 kda [2] and an isoelectric point of about 6 to 8.7. [0003] Clinically, IL-2 has been used to enhance effector immune responses in cancer and infectious diseases [3,4]. It is now approved to treat cancer in humans. [0004] In adjuvant therapy for renal cell carcinoma (RCC), one of its registered indications, less than 10% of patients responded to treatment. This limited potency of IL-2 is now partly explained by the recent discovery that I...

Claims

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Application Information

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IPC IPC(8): A61K38/20A61P37/06A61P37/08A61P29/00
CPCA61K38/00A61K38/12A61K38/2013A61P3/10A61P9/00A61P37/06A61K38/20
Inventor 大卫·克拉茨曼大卫·萨阿顿帕特里斯·卡库米谢勒·罗森瓦吉埃利亚内·皮亚焦吉尔贝·邦西蒙克洛德·贝尔纳
Owner 公共事业救济局-巴黎医院
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