Immuron Announces Results from Clinical Trial in Patients with NASH
23 August 2010: Melbourne & Sydney: Immuron (ASX: IMC) reports the successful results of an open label Phase I/II clinical trial of two oral formulations of hyper-immune bovine colostrum powder (BCP), Imm122-I and Imm124-E, for the treatment of the liver disease non-alcoholic steatohepatitis (NASH) and aspects of metabolic syndrome. NASH is a chronic inflammatory disorder of the liver, also known as fatty liver disease. It is associated with insulin resistance, excessive amounts of triglycerides and other fats inside liver cells (hepatic steatosis) and abnormal liver function. Treating NASH is estimated to be a multi-billion dollar market and no effective treatment is currently available.
Immuron is already actioning a number of the requirements towards commencement of an FDA compliant multisite trial. The trial of Imm122-I and Imm124-E was conducted at the Hadassah Medical Center in Jerusalem, Israel, in accordance with GCP (Good Clinical Practice) protocols. Two groups of 10 patients, all with NASH, were treated for 30 days followed by safety monitoring for 30 days. One group was treated with two oral capsules, each equivalent to 100 mg Imm122-I hyperimmune BCP, three times a day and the other group was treated with 2 oral tablets a day, each equivalent to 200 mg of hyperimmune Imm124-E BCP.
The trial showed that oral administration of both Imm122-I and Imm124-E had a beneficial effect in patients with NASH, insulin resistance and hyperlipidaemia (high blood fats) as measured by accepted tests for these conditions. Both of Immuron’s formulations were very well tolerated, as is the case with other products based on the Immuron hyper-immune BCP platform. There were no adverse events.
The trial demonstrated an improvement in liver function, as measured by a reduction in serum liver enzyme levels. An improvement was also seen in insulin resistance based on accepted tests: fasting blood glucose levels, oral glucose tolerance test (OGTT) and HbA1c levels. Decreased lipid levels were seen in 70% of patients. In addition, 70% of patients showed an increase in regulatory T cells (these cells are associated with suppressing inflammation)
Immuron’s Chief Executive Officer, Dr Grant Rawlin, said: “This trial represents a pivotal milestone for Immuron and demonstrates that the company has two product candidates for the treatment of NASH, one of the most common liver diseases in the western world, for which no effective treatment is currently available. The results relating to metabolic syndrome are also promising and important, particularly with the increasing incidence of type II diabetes in developed countries. As part of its product development program, Immuron intends to discuss a multi-site study of Imm122-I and/or Imm124-E with the FDA. The Company may be entitled to fast track product development due to the "unmet need" status of NASH.”
ENDS ASX Release 23 August 2010 About Immuron Limited Immuron is a biopharmaceutical company focused on oral immunotherapy using dairy-derived polyclonal antibody products for humans. Current products and product candidates target infectious diseases of the gastrointestinal tract, chronic diseases such as type II diabetes and fatty liver (NASH), and prevention of influenza. Immuron’s main scientific alliances are with Hadassah Medical Center (Israel) and the University of Melbourne (Australia).
About NASH and Metabolic Syndrome NASH (non-alcoholic steatohepatitis) 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 ‘Nonalcoholic 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. The potential NASH market is estimated to be a multi-billion dollar market. Metabolic Syndrome is a combination of medical disorders (type II 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.
For more information please contact: Dr Grant Rawlin – Chief Executive Officer Immuron Ltd Tel: +61 3 9018 4880 Email: firstname.lastname@example.org
Prof Colin Chapman – Chairman Immuron Ltd Tel: +61 3 9018 4880
Media Relations: Fay Weston – Director Talk Biotech Pty Ltd Tel: +61 2 4885 2662 or +61 (0)422 206036 Email: email@example.com
Fay Weston Director Talk Biotech T: +61 2 4885 2662 M: +61 422 206036
Posted: August 2010