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Immuron Ltd — Regulatory Filings 2014
Nov 26, 2014
35121_rns_2014-11-26_9838f424-1ac8-48c4-867b-44da07a10885.pdf
Regulatory Filings
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Immuron Secures Ethics Approval for its NASH Clinical Trials in all six Participating Australian Sites
Melbourne, Australia - 27 November 2014: Australian biopharmaceutical company Immuron Limited (ASX: IMC) is pleased to announce that it has secured ethics approval for all the six Australian hospitals that are participating in its clinical trials for non-alcoholic steatohepatitis (NASH).
The hospitals’ ethics approval is required, in addition to FDA clearance, to permit each hospital participating in the trial to commence treating patients with Immuron’s NASH therapeutic candidate IMM142E. The Australian sites are now permitted to recruit patients, which is within the time indicated in the company’s announcement dated 15 October 2014. In addition to the six Australian sites, Immuron’s clinical trials are planned to be carried out in eight hospitals in the US for which Immuron has commenced seeking ethics approval.
The trials are designed as placebo-controlled, double-blinded and dose ranging multi-centre studies for NASH patients, all of whom will be treated for six months.
Contacts:
Amos Meltzer, Chief Executive Officer Investor Relations +61 (0)437 587 680 Gabriella Hold, Buchan Consulting +61 (0)3 9866 4722
Websites: www.immuron.com and www.travelan.com
About Immuron
Immuron (ASX:IMC) is a Melbourne based biopharmaceutical company focused on the development of oral immunotherapy treatments using dairy-derived antibody products. Immuron has a unique technology platform producing products all with a very high safety profile. Immuron sells Travelan®, the world’s first effective over-thecounter preventative for travellers’ diarrhoea, currently available in Australia and Canada. Immuron is progressing two Phase II trials for IMM-124E, for the treatment of inflamed fatty liver diseases and preclinical trials for IMM-529 for the treatment of Clostridium difficile infection due to the overuse of antibiotics. 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.
www.immuron.com Phone: + 61 (0)3 9824 5254 Facsimile: + 61 (0)3 9822 7735
ABN: 80 063 114 045
Suite 1, 1233 High Street Armadale, Victoria AUSTRALIA 3143