Methods of treating non-alcoholic steatohepatitis (nash) using cysteamine products

A steatohepatitis, non-alcoholic technology, applied in the direction of medical preparations containing active ingredients, non-central analgesics, botanical equipment and methods, etc.

Inactive Publication Date: 2010-12-29
RGT UNIV OF CALIFORNIA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

There are currently no satisfactory treatments av...

Method used

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  • Methods of treating non-alcoholic steatohepatitis (nash) using cysteamine products
  • Methods of treating non-alcoholic steatohepatitis (nash) using cysteamine products
  • Methods of treating non-alcoholic steatohepatitis (nash) using cysteamine products

Examples

Experimental program
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Effect test

Embodiment 1

[0096] Enteric coated cysteamine preparation

[0097] International Publication No. WO 2007 / 089670 describes the administration of cysteamine to patients with cystinosis using a nasoenteric tube to determine the effectiveness of enteral administration for improvement in patients with cystinosis. WO 2007 / 089670 shows that enteral administration of cysteamine increases the rate of cysteamine absorption and increases plasma cysteamine levels. Enteral administration also reduces cystine levels within leukocytes. These results indicate that enteral administration of cysteamine is more effective than oral administration of cysteamine.

[0098] For more effective and easier administration, an enteric-coated formulation of cysteamine (Cystagon-EC) was established. Capsules (Mylan Laboratories Inc., PA, USA) were enteric coated using a Wurster coating unit model 600 with a 4 / 6" chamber. The coating material was Eudragit L30D-55 (Rohm GmbH & Co KG, Darmstadt, Germany ) and the...

Embodiment 2

[0102] Administration of cysteamine to patients with fatty liver disease

[0103] Administration of cysteamine has been shown to reduce cystinosis symptoms by reducing levels of damaging cystine. To determine the role of cysteamine on fibrosis causing liver damage in patients with NASH, an open-label, nonrandomized pilot study of enteric-coated cysteamine in 12 children and adolescents with nonalcoholic fatty disease was conducted. Research.

[0104] Patients with a definitive diagnosis of NASH who had undergone lifestyle changes (such as diet and exercise) for at least 3 months were included in the study. Complete medical history and physical examination. Symptom scores designed for acid-digestive disease and previously used in children taking cysteamine were used. Blood was drawn for liver function tests, including liver transaminases, alkaline phosphatase, bilirubin, and gamma-GT. Blood was also drawn for complete blood count, ESR, CRP, fasting insulin and fasting lipid...

Embodiment 3

[0110] Effects on cysteamine preparations were assessed in a dietary animal model of nonalcoholic fatty liver disease (NAFLD) as described by Otogawa et al., Am. J. Pathol., 170(3):967-980 (2007). Male New Zealand white rabbits were fed a high fat diet (HFD) containing 20% ​​corn oil and 1.25% cholesterol to induce the clinical and histological features of NAFLD and nonalcoholic steatohepatitis (NASH). A pilot study of 7 days duration was conducted with cysteamine bitartrate administered intraperitoneally (IP) on an every 8 hour schedule (Q8H) at two dose levels, 75 or 250 mg / kg / day. Longer studies of the 8-week duration phase delivered cysteamine bitartrate in drinking water at 25, 75, or 250 mg / kg / day.

[0111] As discussed in further detail below, data from two studies showed that cysteamine treatment improved liver transaminase (aspartate aminotransferase or AST) levels compared to HFD-treated controls. Elevated AST is considered to be one of the best markers of l...

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PUM

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Abstract

The disclosure relates, in general, to treatment of fatty liver disorders comprising administering compositions comprising cysteamine products. The disclosure provides administration of enterically coated cysteamine compositions to treat fatty liver disorders, such as non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Application No. 60 / 991,517, filed November 30, 2007, and US Provisional Application No. 61 / 085,397, filed July 31, 2008, the disclosures of each of which are incorporated herein by reference in their entirety. technical field [0003] The present invention generally relates to materials and methods for the treatment of fatty liver disease using preparations of cysteamine. Background technique [0004] Fatty liver disease (or steatohepatitis) is often associated with excessive alcohol intake or obesity, but there are other causes as well, such as metabolic defects, including insulin resistance and diabetes. Fatty liver results from the accumulation of triglyceride fat within the vacuoles of liver cells, which leads to a decrease in liver function and may lead to cirrhosis or liver cancer. [0005] Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseas...

Claims

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Application Information

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IPC IPC(8): A01N31/00A61K31/095
CPCA61K9/4891A61K31/145A61K45/06A61P1/16A61P29/00A61P35/00A61P3/06A61P43/00A61P7/00A61P3/10A61K2300/00
Inventor 兰詹·多希尔杰里·施奈德
Owner RGT UNIV OF CALIFORNIA
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