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Immuron Ltd — Capital/Financing Update 2013
Nov 7, 2013
35121_rns_2013-11-07_84821871-79c7-42e7-9017-e908eacb2271.pdf
Capital/Financing Update
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ABN: 80 063 114 045 Level 1, 18 Kavanagh Street Southbank, Vic 3006 Tel: +61 3 8648 4530 www.immuron.com
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US FDA CLEARS ANOTHER IND FOR PHASE 2 TRIAL FOR IMMURON’S IMM‐124E
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Phase 2 ASH trial cleared without FDA raising concerns
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Unmet medical need
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Instructive of Immuron’s NASH trials
Melbourne, Australia, 8 November 2013 : Australian biopharmaceutical company Immuron Limited (ASX: IMC), today announced that the United States Food and Drug Administration (US FDA) has cleared an Investigational New Drug (IND) submission to commence a clinical trial of IMM‐124E, a bovine colostrum‐derived therapeutic, for the treatment of Alcoholic Steatohepatitis (ASH).
This follows Immuron’s announcement on 6 August 2012 that the principal investigator for its impending NASH Phase IIb clinical trial, Arun Sanyal M.D., has been awarded a National Institutes of Health (NIH) grant to conduct a clinical trial for the related condition known as ASH. This trial will be conducted by the TREAT consortium, one of the world’s leading collaborations for clinical research into fatty liver diseases.
NASH and ASH each arise from different causes, and both result in liver damage that can progress to liver fibrosis, liver cirrhosis and lead to of hepatic carcinoma. For this reason, the ASH trial is expected to provide Immuron with additional guidance on its impending NASH trials for which a IND was cleared as announced on 10 January 2012 (see:
http://www.asx.com.au/asxpdf/20120110/pdf/423pd4rggy717b.pdf). Immuron is expecting to deliver its Investigational Medicinal Product imminently for commencement of the trial.
Immuron’s Chief Executive Officer Amos Meltzer said: “The timing of commencement of this trial augers well for Immuron in light of the company’s intention to commence its NASH clinical trials next year.”
Contact
Amos Meltzer – Chief Executive Officer +61 (0) 437 587 680
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 the prevention of influenza. Immuron has one product in the market, Travelan, for preventing travellers’ diarrhoea. Immuron’s main scientific alliances are with Hadassah Medical Center (Israel) and Monash University (Australia).