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Immuron Ltd — Regulatory Filings 2017
Feb 5, 2017
35121_rns_2017-02-05_7e7242fe-7e87-497b-a31f-643d7f779c11.pdf
Regulatory Filings
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Immuron Announces First Patient Enrolled in Pediatric Fatty-Liver Phase II Trial
Melbourne, Australia, 6 February, 2017: Immuron Limited (ASX: IMC), an Australian biopharmaceutical company focused on oral immunotherapy utilizing polyclonal antibody products to target inflammatorymediated diseases, today announced that Emory University has enrolled its first patient in Immuron’s IMM124E pediatric NAFLD (Non-Alcoholic Fatty Liver Disease) Phase II trial.
This NIH-funded Phase II, double blind, placebo control, randomized study, is designed to assess the safety and efficacy of IMM-124E for the treatment of Pediatric NAFLD. The principal objective of this study is to evaluate whether 12 weeks of IMM-124E treatment in children with confirmed NALFD will decrease serum ALT. The study aims to enroll 40 pediatric patients.
Pediatric NAFLD (Non-Alcoholic Fatty Liver Disease) is a progressive form of liver disease associated with excessive fat storage in the liver together with inflammation, which can then lead to liver fibrosis and cirrhosis. Pediatric NAFLD is believed to affect up to 5% - 10% of the US pediatric population. A US landmark study that examined the incidence of disease in 742 autopsy children who had died of an accident, found that 17.3% of the children aged 15 to 19 years had Non-Alcoholic Fatty Live Disease (NAFLD). There are currently no treatments approved for the treatment of pediatric NAFLD.
In previous studies conducted by Emory University, it was demonstrated that children with NAFLD have endotoxemia as well as systemic inflammation. Further, patients with NAFLD have a disturbed microbiome (dysbiosis) and increased gut permeability. Thus, the mechanism of NAFLD is thought to include chronic inflammation from intestinal microbiome-derived products (lipopolysaccharide (LPS) and metabolites) which pass through the “leaky gut” to the liver where they activate the innate immune response. We believe that IMM-124E, which is rich in anti-LPS antibodies, will improve insulin resistance and decrease systemic and hepatic inflammation through modulation of bacterial products and the microbiome in pediatric NAFLD.
Dr Dan Peres, Immuron’s Head of Medical, commented:
“We would like to thank Emory University and Dr Miram Vos’ team for partnering with Immuron on this very important trial. As we highlighted, there are no treatments approved for Pediatric NASH and we look forward to the results of this trials to decide on the next stage of the clinical program.”
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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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Company Contact:
Immuron US Investor Relations:
Thomas Liquard John Beveridge Chief Executive Officer Monsoon Communications Ph: +61 (0)3 9824 5254 Ph: +61 (0)3 9620 3333 [email protected] [email protected]
About Immuron:
Immuron Ltd (ASX: IMC; OTCQB: IMROY) is a microbiome company focused on developing and commercialising oral immunotherapeutics for the treatment of a many gut mediated diseases. Immuron has a unique and safe technology platform that enables a shorter development therapeutic cycle. The Company currently markets and sells Travelan® for the prevention of travellers’ diarrhoea, whilst its lead product candidate IMM-124E is in Phase 2b clinical trials for NASH and ASH. These products together with the Company’s other preclinical immunotherapy pipeline products targeting immune-related diseases currently under development, will meet a large unmet need in the market.
For more information visit: http://www.immuron.com/
Forward-Looking Statements:
Certain statements made in this release are forward-looking statements and are based on Immuron’s current expectations, estimates and projections. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “guidance” and similar expressions are intended to identify forward-looking statements. Although Immuron believes the forward-looking statements are based on reasonable assumptions, they are subject to certain risks and uncertainties, some of which are beyond Immuron’s control, including those risks or uncertainties inherent in the process of both developing and commercialising technology. As a result, actual results could materially differ from those expressed or forecasted in the forward-looking statements. The forward-looking statements made in this release relate only to events as of the date on which the statements are made. Immuron will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this release except as required by law or by any appropriate regulatory authority.
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