Topical treatment of localized scleroderma

A scleroderma, topical application technology, applied in the direction of skin diseases, allergic diseases, organic active ingredients, etc., can solve the problems that have not shown continuous benefit

Inactive Publication Date: 2016-03-02
PRECISION DERMATOLOGY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, systemic use of these molecules is associated with significant side effects, and clinical trials in scleroderma patients to date have not shown any sequential benefit associated with these agents

Method used

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  • Topical treatment of localized scleroderma
  • Topical treatment of localized scleroderma
  • Topical treatment of localized scleroderma

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0123] Example 1 - Imatinib mesylate formulation for topical application

[0124] background

[0125] The active ingredient, imatinib mesylate (IM), is well known and known to be safe and effective as a systemic chemotherapeutic agent. IM is approved by the U.S. Food and Drug Administration (FDA) and is sold under the trade name. IM can be used to treat chronic myeloid leukemia (CML), gastrointestinal stromal tumors (GISTs) and other malignancies. IM acts as a selective inhibitor of BCR-ABL tyrosine kinase and has additional activity against α-PDGFR, β-PDGFR and KIT receptor kinases. To our knowledge, no studies have examined the pharmacodynamic effects of topically administered IM. It is an object of the present invention to develop topical formulations for the treatment of the connective tissue disease systemic sclerosis (SSc) or scleroderma.

[0126] brief description

[0127] The target IM concentration (20%) was found to be achieved in 3 out of 20+ solvents (incl...

Embodiment 2

[0185] Example 2 - Animal Studies

[0186] C57BL / 6 mice were obtained from Jackson Laboratory (Bar Harbor, ME). An osmotic pump (Alzet, model 2001) designed to deliver 1 μL / h was loaded with TGF-β (1.25 μg) in phosphate buffered saline (PBS) supplemented with 0.1 mg / mL bovine serum albumin (BSA). Pumps were implanted subcutaneously in 8-week-old mice, which were subsequently treated with imatinib or placebo cream. After 7 days, the mice were sacrificed and the skin around the pump outlet (~1 cm 2 ) to prepare RNA, or fix in formalin. Skin from mice treated with PBS and TGF-β was analyzed using nanostring technology. A panel of 50 genes including inflammatory genes, macrophage markers, TGF-β regulatory genes, etc. was analyzed. 100 ng RNA per sample was used and gene expression was normalized to the expression of 8 housekeeping genes.

[0187] See, eg, Christmann, R.B. et al., Arthritis Rheum. 2013 May;65(5):1335-46 (teaching that thymic stromal lymphopoietin is upregula...

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Abstract

Disclosed are compositions and formulations for topical administration that contain a tyrosin kinase inhibitor, such as imatinib or nilotinib. The topical compositions or formulations are useful in treating scleroderma.

Description

[0001] related application [0002] This application claims the benefit of priority to US Provisional Patent Application Serial No. 61 / 844,983, filed July 11, 2013, which is incorporated herein by reference. Background technique [0003] Systemic sclerosis, also known as scleroderma, is a chronic systemic autoimmune disease (mainly cutaneous) characterized by fibrosis (or sclerosis), vascular changes and autoantibodies. There are two main forms: (1) Localized systemic sclerosis / scleroderma includes cutaneous manifestations primarily affecting the hands, distal arms and face. It was formerly known as CREST syndrome and refers to the following complications: calcium deposits, Raynaud's phenomenon, esophageal dysfunction, digital sclerosis, and telangiectasia. In addition, pulmonary hypertension may occur in up to one-third of patients and is the most serious complication of this form of scleroderma; and (2) diffuse systemic sclerosis / scleroderma progresses rapidly and affects m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/506A61K31/505A61P17/00
CPCA61K9/0014A61K31/404A61K47/10A61K9/06A61K47/38A61K31/506A61P17/00A61P17/02A61P29/00A61P37/00A61P43/00
Inventor M·W·特朗博M·P·雷德蒙R·A·拉夫亚迪斯P·R·马吉
Owner PRECISION DERMATOLOGY
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