Highlights:
· Data accepted by peer review
· Successful clinical data from Phase 1/II trial published
· Focus on a potential treatment for unmet medical need
3 November 2010, Melbourne and Sydney Australia: Immuron (ASX: IMC) has presented posters detailing its recent results on the treatment of the liver disease non-alcoholic steatohepatitis (NASH) and aspects of metabolic syndrome at the American Association for the Study of Liver Disease (AASLD) 2010 annual conference currently being convened in Boston.
The AASLD annual conference is the most important conference relating to liver disease and is attended by the world’s key opinion leaders, clinicians, scientists and pharmaceutical companies involved in liver diseases. Immuron is delighted to be able to present its clinical trial results at the meeting.
The posters report on Immuron’s recent successful results in a Phase I/II clinical trial of its hyperimmune bovine colostrum product IMM 124E for the treatment of NASH and aspects of metabolic syndrome (announced 24 August 2010) and earlier animal studies.
This clinical trial completed recently at the Hadassah Hebrew University Medical Center has successfully shown that oral administration of IMM 124E is safe and effective, and exerts an immunomodulatory effect in patients with insulin resistance/type 2 diabetes, hyperlipidemia and NASH. All primary and secondary endpoints were successfully achieved with improvements observed across all clinical parameters. The product was well tolerated and no drug related adverse events were recorded during the clinical trial. Details of the results are set out in the table below.
The primary endpoint of an improvement in liver enzyme levels (AST, ALT, AP and GGT) was attained.
The secondary endpoints of improvement in levels of insulin resistance and lipid levels were measured using the HBA1C test, and Oral Glucose Tolerance Test (OGTT), and lipid tests. The majority of patients improved in measures of insulin resistance.
Further physiological markers of the metabolic syndrome were tested (GLP-1 and Adiponectin levels). There was improvement in these markers as well.
In addition to these results, seventy percent of patients showed a significant increase in regulatory T cell measurements.
Currently, there is no approved or effective treatment for the chronic liver disease NASH. The treatment of NASH is a significant unmet medical need. With incidence rising, treatment of NASH represents a large and growing market currently estimated to be worth multiple billions of dollars.
Immuron’s Chief Executive Officer, Dr Grant Rawlin, said “Our recent clinical trial demonstrated that we have a serious product candidate for the treatment of NASH, one of the most common liver diseases in the western world. We are delighted to have the opportunity to share our findings at one of the most prestigious liver disease conferences in the world.”
Abstracts of the posters have been published in the journal Hepatology and can be accessed from Immuron’s website.
Mizrahi M, Lalazar G, Shabat Y, Adar T, Ben Ya'acov A, Ilan Y. Alleviation of insulin resistance and liver damage by oral administration of ETEC colostrums is mediated by increased GLP-1, adiponectin serum levels and Tregs: Results of a phase I/II clinical trial in NASH. Hepatology, 52:163A, 2010.
Adar T, Lichtenstein Y, Lalazar G, Mizrahi M, Zolotarov L, Ben Ya'acov A, Ilan Y. Induction of CD4+CD25+FOXP3+ regulatory T cells by oral administration of IgG enhanced colostrums suppressed the chronic inflammatory state in OB/OB mice alleviating the insulin resistance and liver injury. Hepatology, 52:262A, 2010.
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