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Immuron Ltd — Investor Presentation 2010
Sep 29, 2010
35121_rns_2010-09-29_07e1c43e-51fd-44de-a8f9-b3f310561c33.pdf
Investor Presentation
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INVESTOR UPDATE SEPTEMBER 2010
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In anticipation of our Annual General Meeting scheduled for 29 November 2010, we would like to update you on the status of our progress in recent months.
In a relatively short time, Immuron has transformed itself in a number of respects. Until quite recently, Immuron was a company with its marketed product, Travelan, and a number of early stage products earmarked for development as complementary medicines.
HIGHLIGHTS
NASH – IMM 124E INFLUENZA – IMM 255 PIPELINE UPDATE COMMERCIALISATION UPDATE
Today Immuron is a clinical stage company focused on developing novel therapeutic products for a range of indications including products with a high level of unmet medical need, all of which are designated for Food and Drug Administration (FDA) sanctioned clinical trials.
The exciting prospects we now face is a function of the success we attained in our clinical trials for Non‐ alcoholic steatohepatitis (NASH ‐ discussed further below). These trials provide evidence that our platform is effectively generating therapeutics that elicit a desired response in patients that is not associated with general immune suppression, has a high safety profile, is well tolerated and can be developed within relatively rapid time lines. These considerations are partly the reason for our belief that our success with our NASH product can be replicated with our influenza project as well as others.
Our focus is now:
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pursuing our clinical program for the treatment of NASH for which there is no current effective treatment and a large potential market;
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continuing our ferret trials for a preventative and treatment for influenza , which is the “gold standard” model, for which results are expected by April 2011, in advance of proceeding to clinical trials;
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developing our earlier stage programs towards the clinic, which we believe can be done in relatively short time; and
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the further commercialisation of Travelan and engaging with prospective licensees in relation to the commercialization of our NASH and influenza products.
We are also pleased to announce that we have launched our new website which can be found at www.immuron.com and would encourage you to use the facility on the site to sign up to receive future newsletters directly via email.
NON‐ALCOHOLIC STEATOHEPATITIS (NASH) – IMM 124E
On 23 August Immuron announced the successful results of an open label Phase I/II clinical trial of two oral formulations of hyper‐immune bovine colostrum powder (BCP), IMM 122I and IMM 124E, for the treatment of the liver disease, NASH and aspects of Metabolic Syndrome.
The full results of this clinical trial will be presented at the 61[st] Annual Meeting of the American Association for the Study of Liver Diseases in late October.
Immuron is intensely preparing for a pre‐IND (Investigational New Drug) meeting with the FDA in the USA in anticipation of submitting an IND application, which is needed to commence clinical trials. The aim of the discussions with the FDA will be to prepare and seek agreement and advice on the development plan and regulatory pathway for a multi‐site study of IMM124E in Israel and the USA for NASH.
Why was this trial important?
The results of this clinical trial are significant for three principal reasons:
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From a technology perspective, we have now demonstrated clinical proof of principle for our NASH product candidate and are confident about its ongoing safety profile.
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There is no effective medical therapy currently available to treat NASH . NASH is currently treated off‐ label by drugs that treat the risk factors associated with NASH but not the disease itself.
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Should Immuron succeed in its clinical program, it will be presented with the prospect of having a therapeutic product on the market for which there is currently an unmet medical need. It is estimated by the American Liver Foundation that there are 7.5 million Americans that suffer from NASH and for which the National Center of Infectious Diseases predicts that by 2025 more than 25 million may be affected.
What is NASH?
NASH is a chronic inflammatory disorder of the liver, also known as fatty liver disease and is considered to be one of the diseases of Metabolic Syndrome. The diagram below sets out the various diseases which are part of Metabolic Syndrome, of which NASH is but one.
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NASH is associated with insulin resistance (Type 2 Diabetes), excessive amounts of triglycerides (hyperlipidaemia) and other fats inside liver cells (hepatic steatosis) and abnormal liver function . NASH is one of the most common liver diseases in the western world. It is estimated that NASH affects 5% of the lean population, 20% of the obese population and 50% of morbidly obese people. It resembles alcoholic liver disease, but occurs in people who drink little or no alcohol.
NASH occurs most commonly in adults over the age of 40 who are overweight or have diabetes, insulin resistance or hyperlipidaemia. Due to the high prevalence of diabetes, obesity and hyperlipidaemia worldwide, the incidence of NASH is likely to rise in the near future.
In the early stages of the disease patients do not exhibit any symptoms but as the disease progresses they may suffer symptoms such as fatigue, weight loss, weakness and frequent infections. NASH can be severe and can lead to cirrhosis, in which the liver is permanently damaged and scarred and no longer able to function properly. Liver transplantation is the only option available for late stage NASH. NASH ranks as one of the leading causes of cirrhosis in the USA after hepatitis C and alcoholic liver disease. One in five patients who
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have NASH for more than 10 years advance to liver cirrhosis and approximately 10% of NASH patients die due to a liver related problem.
INFLUENZA – IMM 255
Based on the successful results in mice, Immuron is currently in the midst of carrying out challenge model influenza studies in ferrets at the CSIRO Animal Health Laboratory in Geelong. The trials commenced in July and may consist of up to four separate arms to test dosage, frequency of dosage, etc.
The ferret model is accepted as the ‘Gold Standard’ animal model to explore a preventative treatment against human epidemic and pandemic influenza viruses including the H1N1 (“swine flu”) strain. Success in the ferret model is acknowledged as highly significant by both international regulatory authorities and potential business partners as an indication of future success in the human clinical setting.
The significance of these trials is that if these trials are successful, the Company expects that it will then be able to proceed towards clinical trials in humans.
Immuron has already obtained the consent of the ethics committee at Hadassah Medical Center to commence clinical trials and Immuron is awaiting further data from the ferret trials and further mouse model work before we finalise the trial design. This clinical trial is expected to be a Proof of Concept trial monitoring both safety and efficacy.
One of the principal advantages of Immuron’s approach to influenza lies in the nature of its polyclonal antibodies which appear to be more effective in treating and preventing influenza caused by quickly evolving strains of virus.
Another advantage is that Immuron’s orally ingested therapeutic is expected to be suitable for children, who may be too young to receive conventional vaccinations and in the elderly population who may not respond well to vaccinations.
Immuron has demonstrated its ability to generate large amounts of dairy‐derived polyclonal influenza‐specific antibodies. To date, these antibodies have shown efficacy in both the prevention and treatment of influenza in mouse models. In collaboration with the University of Melbourne’s Department of Microbiology & Immunology, Immuron has completed further studies in mouse models which have been very successful. Results from these studies will be published in a peer reviewed journal by the end of 2010. In addition, mouse trials of the formulation are also being conducted in Israel at the Hadassah Medical Center to investigate other aspects of anti‐influenza immunity involving cell mediated immunity markers. This work has progressed well over the last 6 months and the results will be transferred to the Australian team at the University of Melbourne for further testing in mice.
FURTHER PIPELINE UPDATES
We continue to progress with our product candidates such as IMM 308 for Clostridium difficile infection and IMM 252 as an HIV microbicide.
We have attained approval for a Phase II clinical trial in Clostridium difficile to commence in Israel subsequent to successful results in the animal models.
Clostridium difficile is the most serious cause of antibiotic‐associated diarrhoea (AAD). People are most often infected in hospitals and nursing homes but C. difficile infection in the outpatient setting is increasing. Relapses
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of C. difficile infection can range in severity from asymptomatic to severe and life‐threatening, especially among the elderly. There is a significant need for alternative therapies that are not reliant on antibiotics to treat, prevent or stop recurrence after primary treatment.
The emergence of a new, highly toxic strain of C. difficile , resistant to fluoroquinolone antibiotics and hyper virulent was identified in 2005. This is often referred to as the Quebec strain.
It has been demonstrated that Immuron’s product neutralizes the necrotic toxin (Toxin B) of Clostridium difficile in cell culture. Clinical proof of principle has already been established for this method of treatment and prevention in a Phase II clinical study in the USA undertaken by ImmuCell Corporation who licensed the technology to Immuron.
Immuron has now successfully created sets of dairy‐derived polyclonal antibodies that neutralised many strains (or ‘clades’) of HIV virus. The HIV‐neutralising antibodies produced are suitable for large‐scale production and future studies will develop a mucosally applied product to protect uninfected patients from HIV infection in high‐risk settings. The next step will investigate the use of improved glycoprotein vaccine formulations to produce antibodies and assess the ability of these antibodies to block HIV virus in biological fluids. If this work is successful the project will advance into safety and efficacy testing in animal models.
In order to be able to focus its resources on the most promising projects Immuron has decided to discontinue development of its product for cancer treatment related mucositis. The trial conducted at the Tel‐Aviv Medical Center was a limited trial with only eight candidates and the results were inconclusive.
COMMERCIALISATION UPDATE
Immuron is in the initial stages of discussion in relation to a number of possibilities for licensing its products and product candidates.
In May 2010 Travelan™ was licensed to Nycomed for marketing and distribution in Australia and New Zealand.
In addition, the Company is in discussions with potential partners for the marketing and distribution of Travelan in other territories and also in relation to IMM 272 for the prevention and treatment of Rotavirus.
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CONTACT US
We welcome your feedback on this investor update and would like to encourage you to let us know what you think and ask any further questions. Please email us at [email protected] with your suggestions and questions.
Immuron Limited
Level 1, 39 Leveson Street
North Melbourne Vic. 3051
Telephone 61 (0) 3 9018 4880
4 www.immuron.com