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Immuron Ltd Regulatory Filings 2013

Mar 3, 2013

35121_rns_2013-03-03_d44bfe27-9b98-4ebd-855a-3a776de771a8.pdf

Regulatory Filings

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ABN: 80 063 114 045 Level 1, 18 Kavanagh Street Southbank, Vic 3006 Tel: +61 3 8648 4530 Fax: +61 3 9686 9460 www.immuron.com

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IMMURON’S IMM-529 PRODUCT TAKES ANOTHER STEP FORWARD AGAINST CLOSTRIDIUM DIFFICILE

  • Unique and effective vaccine under development

  • Resulting product candidate targeted to prevent symptoms

  • New patent applications identified

  • Non-antibiotic formulation to meet clinician preference

04 March 2013, Melbourne, Australia : Australian biopharmaceutical company Immuron Limited (ASX: IMC), today announced additional results demonstrating that IMM-529 is effective in preventing Clostridium difficile ( C. difficile ) symptoms in mice. These results, combined with those reported on 17 December 2012, demonstrate the significance of IMM-529 as a prophylaxis for C. difficile infection. The most recent studies, conducted by Monash University, are expected to strengthen the intellectual property that protects IMM-529 and to support commencement of human clinical trials. As previously announced, Monash University’s studies are being carried out with government financial support.

C. difficile infection causes severe diarrhea leading to colitis and other serious, potentially life threatening, intestinal conditions when competing bacteria in the gastrointestinal tract have been wiped out by antibiotics, and the C. difficile bacteria is free to grow.

The most recent study looked at the survival rate, weight loss and histopathology of mice having been treated with IMM-529 prior to being exposed to the C. difficile bacteria. The results demonstrate a strong rationale for continuing the development of a prophylaxis product, and strengthen the intellectual property around this product. Additional studies are planned to investigate IMM-529’s efficacy in treating C. difficile post-infection, support the patent applications and support a human clinical trial. Readiness for clinical trials is expected as early as this calendar year.

C. difficile infections are increasing due to the wide-spread use of antibiotics. The most recently approved product to treat C. difficile infection is a macrolide antibiotic drug that demonstrates a comparable efficacy to vancomycin, the previous treatment of choice. Both these treatments cost in excess of $1,800 USD per person for a 10 day treatment. There is no preventative product currently available.

Contact

Amos Meltzer – Chief Executive Officer +61 3 8648 4530

About Immuron Limited

Immuron is a biopharmaceutical company focused on oral immunotherapy treatments using dairy-derived antibody products for humans. Immuron is uniquely positioned with a versatile technology platform capable of generating a wide range of products with a high safety profile. This high safety profile makes it possible to complete pre-clinical studies relatively quickly and increases the prospect that the clinical development of Immuron’s products will be expedited. Immuron’s current products and product candidates target infectious diseases of the gastrointestinal tract, chronic diseases such as fatty liver/NASH, and influenza. Immuron has one product in the market, Travelan, for preventing travellers’ diarrhoea. Immuron’s main scientific alliances are with Hadassah Medical Center (Israel), the University of Melbourne and Monash University (Australia).

About Clostridium difficile

C. difficile infections have become a major medical problem especially in hospitals and long-term care facilities because the bacteria produce toxins that cause inflammation of the colon, causing severe diarrhoea and, in serious cases, death. An estimated 28,000 people die each year from these infections in the USA, and numbers have significantly increased over the last decade. C. difficile infections result in an estimated annual economic burden of more than US$10 billion globally. Current therapies are based on antibiotics that are not fully effective and that encourage the emergence of antibiotic-resistant strains. Immuron’s hyper-immune colostrum platform technology has the potential to offer a new-paradigm effective therapeutic.