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Immuron Ltd — Regulatory Filings 2015
Jan 14, 2015
35121_rns_2015-01-14_6aa4addc-5b65-416c-aadc-6c1d6b3308c3.pdf
Regulatory Filings
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Patient Recruitment Commenced for Phase 2 ASH Trial and Updates on Phase 2 NASH Trial Progress
Melbourne, Australia - 15 January 2015: Australian biopharmaceutical company Immuron Limited (ASX: IMC) has today announced the commencement of the fully sponsored Phase 2 clinical trial for alcoholic steatohepatitis (ASH) in the United States.
The first three of a planned 66 patients have now been enrolled in the clinical trial for studying Immuron’s IMM-124E for the treatment of ASH. ASH has a poor prognosis and is a syndrome of progressive inflammatory liver injury associated with long-term heavy alcohol consumption. There is no approved drug for the treatment of this disease.
As previously announced, Immuron’s IMM-124E is one of three therapeutic candidates selected by the United States National Institutes of Health (NIH) from 27 therapeutic candidates to be trialed for the treatment of ASH. The trial is sponsored and funded by the US NIH and is expected to provide data that will complement Immuron’s non-alcoholic steatohepatitis (NASH) clinical development program.
IMM-124E is a natural product for the treatment of fatty liver associated with ASH and NASH. IMM-124E contains the natural ingredient Bovine Colostrum Powder that is harvested from dairy cows which are immunised with Immuron’s proprietary vaccine. By vaccinating the cows, Immuron causes a shift in the bovine colostrum antibody composition, which is designed to confer on IMM-124E its pharmaceutical quality.
Immuron’s NASH trial continues to progress with patient screening and selection now ongoing. A number of hospitals are actively seeking to recruit patients and the first patient recruitment is expected imminently.
Immuron Chief Executive Officer Amos Meltzer said: “We are very pleased with the progress made to date. Recruitment is already underway for the ASH trial and we have over 15 sites actively engaged with us, most of whom we expect to start recruiting very soon for the NASH 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
Websites: www.immuron.com and www.travelan.com
Suite 1, 1233 High Street Armadale, Victoria AUSTRALIA 3143
Phone: + 61 (0)3 9824 5254 Facsimile: + 61 (0)3 9822 7735
ABN: 80 063 114 045
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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.
About IMM-124E and ASH
Alcoholic Steatohepatitis (ASH) refers to inflamed fatty liver disease caused by excessive alcohol consumption. Immuron is funded by the US National Institutes of Health (NIH) for the development of its IMM-124E Phase II trial for ASH. Notably, the NIH has chosen to fund IMM-124E as one of three potential treatments for ASH chosen from 27 potential treatments.
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