Quinoline derivative applied to treatment of graft-versus-host diseases

A graft-versus-host technology, which is applied in the field of medicine, can solve the problem of chronic GvHD without a recommended standard treatment plan

Pending Publication Date: 2021-01-29
CHIA TAI TIANQING PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is currently no recommended standard treatment for chronic GvHD that fails first-line therapy

Method used

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  • Quinoline derivative applied to treatment of graft-versus-host diseases
  • Quinoline derivative applied to treatment of graft-versus-host diseases
  • Quinoline derivative applied to treatment of graft-versus-host diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0138] Embodiment 1 clinical trial

[0139] Patients over 18 years old who received allogeneic peripheral blood hematopoietic stem cell transplantation due to hematological diseases were selected, and evaluated according to the 2014 chronic GvHD NIH grading criteria, diagnosed as moderate-severe steroid-resistant chronic GvHD with symptoms of steroid resistance, Specifically: prednisone 1 mg / kg / d or equivalent dose of corticosteroids continued for ≥ 2 weeks, the disease progressed, or prednisone 0.5 mg / kg / d ≥ 4 weeks did not improve, or could not be reduced to <0.5 mg / kg / d.

[0140] Anlotinib capsules, 8 mg, were administered orally once a day for at least 4 weeks; no disease progression was assessed after 4 weeks, or partial remission of the disease was assessed after 12 weeks for at least 6 months.

[0141] The main research endpoint: the effective rate of anlotinib in the treatment of chronic GvHD: the effective rate of anlotinib in the treatment of chronic GvHD within 6 ...

Embodiment 11

[0144] Embodiment 1.1 clinical trial case

[0145] Male, 28 years old, diagnosed with myelodysplastic syndrome (MDS). More than 1 year after allogeneic hematopoietic stem cell transplantation, he was diagnosed with chronic graft-versus-host disease. Examination showed desquamation of the whole body with pigmentation. The back (3cm) And left wrist place (1cm) skin ulcer is accompanied by hemorrhage, adopts hormone, cyclosporine etc. treatment invalid.

[0146] Oral administration of anlotinib capsules 8mg once a day, skin pigmentation and ulcers improved after 2 weeks.

Embodiment 12

[0147] Embodiment 1.2 clinical trial case

[0148] Male, 32 years old, diagnosed with chronic myelomonocytic leukemia for more than 1 year, more than 10 months after allogeneic hematopoietic stem cell transplantation, chronic GvHD evaluation was skin 2 points, oral cavity 2 points, eyes 1 point, lung 1 point, moderate, Hormone dependence. The patient had oral ulcers and bleeding around the lips. On April 11, 2020, 8 mg of anlotinib was administered orally once a day. At the same time combined with methylprednisolone tablets (methylprednisolone), the daily dose of 12mg, orally twice a day, cyclosporine capsules, 25mg, once a day. Examination on June 18, 2020, chronic GvHD was evaluated as 1 point for skin, 1 point for oral cavity, mild, and hormone dependence.

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Abstract

The invention belongs to the technical field of medicine, and relates to a quinoline derivative applied to treatment of graft-versus-host diseases. Specifically, the invention relates to the application of a compound I or a pharmaceutically acceptable salt thereof to the treatment of the graft-versus-host diseases, in particular to patients with moderate and serious chronic graft-versus-host diseases. The compound I or the pharmaceutically acceptable salt thereof is capable of improving the treatment efficiency of hormone-resistant chronic graft-versus-host diseases, reducing the graft-versus-host disease-related death rate of the patient and enhancing the survival rate of the patient. The chemical name of the quinoline derivative I is 1-[[[4-(4-fluoro-2-methyl-1H-indole-5-yl)-oxy-methoxyquinol-7-yl]oxy]methyl]cyclopropylamine.

Description

technical field [0001] The application belongs to the field of medicine, in particular, the application relates to the use of quinoline derivatives in the treatment of graft-versus-host disease. Background technique [0002] Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) is an effective treatment for various hematological malignancies, bone marrow failure diseases and some genetic diseases. The main complication of allogeneic stem cell transplantation in Graft Versus Host Disease (GvHD) is that the T lymphocytes in the allogeneic donor graft are stimulated by a series of "cytokine storm" initiated by the recipient after transplantation. , greatly enhanced its immune response to recipient antigens, and launched a cytotoxic attack targeting recipient target cells, of which the skin, liver and intestinal tract were the main targets. The incidence of acute graft-versus-host disease is 30% to 45%, and the incidence of chronic graft-versus-host disease is higher t...

Claims

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Application Information

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Patent Type & AuthorityApplications(China)
IPC IPC(8): A61K31/4709A61P37/06
CPCA61K31/4709A61P37/06
Inventor宋献民耿文军
OwnerCHIA TAI TIANQING PHARMA GRP CO LTD