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Immuron Ltd Regulatory Filings 2015

Jul 1, 2015

35121_rns_2015-07-01_c92468af-897d-4d28-bcfc-054115990eab.pdf

Regulatory Filings

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NASH TRIAL UPDATE – PATIENT RECRUITMENT ADVANCES

2 July 2015, Melbourne, Australia: Australian biopharmaceutical company Immuron Limited (ASX: IMC), is pleased to announce recruitment for its Phase 2 clinical trial for NASH (Non Alcoholic Steatohepatitis) is progressing with 19 sites initiated globally and ongoing recruitment.

Of the 19 active sites, 13 sites are in the USA and 6 in Australia. 3 additional sites, 2 in Israel and a further site in the USA, are in the process of being initiated, which will bring the total clinical sites to 21 over the coming months.

NASH is a progressive form of non-alcoholic fatty liver disease (NAFLD) characterised by fat buildup in the liver (steatosis) and chronic inflammation and may progress to cirrhosis, liver failure and even cancer. The prevalence of NASH is increasing globally, associated with rising obesity, dyslipidemia and type 2 diabetes.

In December 2014 Immuron announced its initiation of a multinational, multicenter, Phase 2, randomised, double-blind, placebo-controlled study of IMM-124E to treat NASH patients. The study protocol was prepared in collaboration with a scientific advisory board led by Prof. Arun Sanyal of Virginia Commonwealth University in Richmond, VA, who is a world leading NASH specialist.

The primary objectives of the study are to evaluate the safety and preliminary efficacy of IMM124E. IMM-124E will be compared to placebo in its potential to reduce liver fat and serum liver enzymes (ALT). The study will enroll a total of 120 patients with liver biopsy confirmed NASH. Patients randomised into the study will be orally administered either 600mg or 1,200mg doses of the study drug IMM-124E or placebo 3 times daily for 6 months. To date 33 patients had been entered into the study with ten continuing on to randomisation and dosing (treated with IMM124E or placebo).

Senior Vice President of Innovation, Dr Dan Peres said:

“We have established an impressive network of world-leading investigators, and now we expect to see an acceleration in recruitment."

Immuron is working closely with its principle investigators and key opinion leaders to develop initiatives to drive recruitment with the aim of having the trial fully recruited by the end of 2015.

Contacts:

Dr Leearne Hinch Dr Dan Peres Amanda Loh Chief Executive Officer (CEO) Senior VP of Innovation Buchan Consulting +61 (0) 402 762 204 +972 545 641 464 +61 (0)3 9866 4722

Suite 1, 1233 High Street Armadale, Victoria AUSTRALIA 3143

www.immuron.com

Phone: + 61 (0)3 9824 5254 Facsimile: + 61 (0)3 9822 7735

ABN: 80 063 114 045

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ABOUT IMMURON

Immuron Ltd (ASX:IMC) is a biopharmaceutical company focused on developing and commercialising oral immunotherapies based on its hyperimmune colostrum technology for the treatment of intestinal and liver diseases. The company currently markets Travelan® for the prevention of travellers’ diarrhoea, its lead product candidate IMM-124E is in Phase 2 clinical trials for NASH and ASH, and it has a preclinical immunotherapy pipeline targeting immune-related diseases with unmet needs. 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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