Melbourne, Australia – 3 February 2015: Australian biopharmaceutical company Immuron Limited (ASX: IMC) has today announced a significant milestone in its Phase 2 clinical trial for non-alcoholic steatohepatitis (NASH) with the recruitment of its first two patients at Duke University in the United States. It is expected that further recruitment at Duke and other sites in the US and Australia will follow in early course.
Immuron’s NASH trial is designed as a 120 patient double-blind, placebo-controlled multi-centre and dose ranging study designed to demonstrate that Immuron’s IMM-124E NASH drug candidate based on its hyperimmune colostrum technology improves certain clinical indicators of NASH.
NASH is a chronic inflammatory disorder of the liver which is believed to afflict more than five percent (5%) of the US population. It develops as a second-stage condition in people with non-alcoholic fatty liver (NAFLD) which is believed to afflict more than twenty five percent (25%) of the US population and is highly correlated with obesity, diabetes and hypertriglyceridemia.
US Investigator, Dr. Manal Abdelmalek said: “I am pleased to be leading Immuron’s IMM-124E Phase II clinical trials at Duke University. We are intent on recruiting up to 20 NASH patients over the next few months in this important clinical trial. Once enrolled, screened and randomized, each patient will be treated for 6 months with IMM-124E.”
Immuron Chariman of the Board of the Directors, Dr. Roger Aston said: “The recruitment of our first patients in this important clinical trial for Immuron and people who suffer from NASH is an important milestone. There is a pressing need to address NASH and this is reflected in the high level of interest in the trial shown by our globally appointed investigators and their keenness to recruit patients. We are continuing to work closely with our appointed sites to support the recruitment of this trial.”
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Contacts:
Amos Meltzer, Chief Executive Officer
+61 (0)437 587 680
Investor Relations
Amanda Loh, Buchan Consulting
+61 (0)3 9866 4722 About Immuron
Immuron is a biopharmaceutical company focused on oral immunotherapy treatments using dairy-derived antibody products for humans. Immuron’s technology platform products all have a very high safety profile. The company’s current products and product candidates address infectious diseases of the gastrointestinal tract as well as chronic diseases. Immuron has an on-market product, Travelan®, for preventing travellers’ diarrhoea. Immuron also has a phase 2 clinical product candidate for the treatment of inflamed fatty liver disease, known as Non-Alcoholic Steatohepatitis or NASH. Immuron’s main scientific alliances are with Hadassah Medical Center (Israel) and Monash University (Australia).
About IMM-124E and NASH
Non-Alcoholic Steatohepatitis (NASH) refers to a spectrum of conditions of the liver all of which involve chronic inflammation of the liver and is highly correlated with obesity, diabetes and high cholesterol. If left untreated NASH may lead over time to fibrosis and then cirrhosis of the liver and severe liver dysfunction. NASH is increasingly a cause of liver cancer and the need for a liver transplant. Immuron’s Phase II trial for IMM-124E is well positioned to leverage this large and growing market with currently no available drug available on the market.
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