IMM 124-E – Non-Alcoholic Steatohepatitis (NASH)/Type 2 Diabetes
NASH (non-alcoholic steatohepatitis) is a chronic inflammatory disorder of the liver, also known as fatty liver disease and is considered to be one of the diseases of Metabolic Syndrome. As such, it is associated with insulin resistance, excessive amounts of triglycerides and other fats inside liver cells (hepatic steatosis) and abnormal liver function. NASH is one of the most common liver diseases in the western world. It is associated with obesity, diabetes and hyperlipidaemia. It affects 5% of the lean population, 20% of the obese population and 50% of morbidly obese people. It resembles alcoholic liver disease, but occurs in people who drink little or no alcohol. The major feature in NASH is fat in the liver (hence another of its names ‘Non-alcoholic Fatty Liver Disease’) along with inflammation and damage. Most people with NASH feel well and are not aware that they have a liver problem. Nevertheless, NASH can be severe and can lead to cirrhosis, in which the liver is permanently damaged and scarred and no longer able to function properly. Treating NASH is estimated to be a multi-billion dollar market and no effective treatment is currently available.
Metabolic Syndrome is a combination of medical disorders (Type 2 Diabetes, fatty liver disease, atherosclerosis, hyperlipidaemia) that increases the risk of cardiovascular disease and diabetes. It affects one in five people, and its prevalence increases with age. Some studies estimate the prevalence in the USA and Australia to be up to 25% of the population. The causes of metabolic syndrome are complex and not fully understood. A common trait is insulin resistance where the body does not use the hormone insulin as effectively as it should, especially in the muscles and liver. When a person has insulin resistance, the pancreas needs to release more insulin than usual to maintain normal blood glucose levels.

Immuron’s Phase I/II clinical trial of IMM 124-E, an oral formulation of hyper-immune bovine colostrum powder (BCP) for the treatment of the liver disease non-alcoholic steatohepatitis (NASH) and aspects of metabolic syndrome reported considerable success in August 2010.
The trial showed that oral administration of both formulations had a beneficial effect in patients with NASH, insulin resistance and hyperlipidaemia (high blood fats) as measured by accepted tests for these conditions.
Immuron announced that it has commenced to prepare to submit to the Food and Drug Administration (FDA) an Investigational New Drug regarding a multi-site study of IMM124-E in Israel and the USA for this indication.
For the announcement, see: http://www.asx.com.au/asxpdf/20100823/pdf/31s1083zw32zwp.pdf.


