29 March 2010, Melbourne and Sydney Australia: Immuron (ASX: IMC) has commenced a Phase II clinical trial of its immunotherapy product for the treatment of Metabolic Syndrome and NASH (Nonalcoholic steatohepatitis). The clinical trial is taking place at the Hadassah Hebrew University Medical Centre in Jerusalem under an agreement between Immuron and Hadasit, the Medical Centre’s commercialisation arm.
This single arm, open label trial is recruiting patients who suffer from Metabolic Syndrome, particularly those with NASH and Type 2 Diabetes. The primary endpoints of the trial will determine the safety and efficacy of Immuron’s product for improving liver enzyme levels in patients with NASH. The secondary endpoints will determine the efficacy of this treatment in improving Metabolic Syndrome with particular reference to insulin resistance. These endpoints will be measured using liver enzyme, glucose metabolism and T regulatory cell population measurements.
Further information on the design of the trial is available at the NIH website www.clinicaltrials.gov and the trial identifier is NCT01016418.
The clinical trial program follows successful animal model work, including data which was presented at the American Liver Association Meeting in 2009. The trials are designed to guide the commercialization of Immuron’s oral antibody based therapies in this area.
The first group of the trial (10 patients) is expected to be fully recruited in early April with results due by the end of June 2010.
Immuron’s Chief Executive Officer, Dr Grant Rawlin, stated “This trial will be a pivotal milestone for the Company. NASH is the most common liver disease in the western world and the incidence of Type II Diabetes is on the rise. Both of these indications represent attractive opportunities for our product.”
About Immuron Limited
Immuron is a biopharmaceutical company focused on oral immunotherapy using dairy-derived polyclonal antibody products for humans. Current products target infectious diseases of the gastrointestinal tract, while more recent projects are targeting immunotherapy to influence chronic diseases such as HIV, Type 2 Diabetes and fatty liver (NASH), and to prevent and treat respiratory infection with influenza. Immuron’s main scientific alliances are with Hadassah Hebrew University Medical Centre (Israel) and the University of Melbourne (Australia).
About NASH and Metabolic Syndrome
Non-alcoholic steatohepatitis or NASH is the most common liver disease in the western world. It is associated with obesity, diabetes and hyperlipidemia. 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 work properly. The total market potential in the USA alone reaches nearly $22 billion.
Metabolic Syndrome is a combination of medical disorders (Type II Diabetes, Fatty Liver Disease, Atherosclerosis, Hyperlipidemia) that increases the risk of developing cardiovascular disease and diabetes. It affects one in five people, and 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. It is thought that more than a quarter of the population has some degree of resistance to insulin.
For more information please contact:
Dr Grant Rawlin – Chief Executive Officer
Tel: +61 3 9018 4880
Einat Zisman, PhD - President and CEO
Fay Weston – Director
Talk Biotech Pty Ltd
Tel: +61 2 4885 2662 or +61 (0)422 206036