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Immuron Ltd — Regulatory Filings 2006
Nov 29, 2006
35121_rns_2006-11-29_f4667890-187d-4bbc-a181-6f7c72465c1e.pdf
Regulatory Filings
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November 30th, 2006
Company Announcement Office Australian Stock Exchange Ltd (ASX) 4th Floor, 20 Bridge Street Sydney NSW 2000
Dear Sir/Madam
Please find herewith a company announcement "Trial for Ulcerative Colitis Commences" for release and distribution to the market immediately.
Yours sincerely
CONOR GRAHAM Managing Director & CEO

Travelan Clinical Trial for the Treatment of Ulcerative Colitis Australian developed therapeutic investigated for additional indication
Australian biopharmaceutical company Anadis Limited (ASX:ANX) is pleased to announce the start of a Pilot Study to investigate an additional and commercially broader use for its lead product Travelan. The pilot study, triggered by positive market feedback, will investigate Travelan's role in reducing symptoms of chronic diarrhoea diseases.
Travelan is already available nationally, as an over-the-counter (OTC) pharmaceutical; in pharmacies for the risk reduction of E.coli associated Travellers Diarrhoea. Travelan is to be sold early in the new year to international markets including the US. Canada and South Africa, with the first order from Canada already received (announcement: First International Order for Travelan received 3/11/06).
Importantly Travelan already has a TGA (Therapeutic Goods Association) approved secondary claim to "reduce the symptoms of minor gastrointestinal disorders".
The Clinical Trial
The clinical trial entitled "Travelan and Ulcerative Colitis Study" will be conducted at St Vincent's Hospital, Melbourne under the supervision of Gastroenterologist Dr William Connell. The study has been designed to directly assess the efficacy of Travelan as an adjunct therapy in mild to moderate Ulcerative Colitis, and further to measure any effects on the inflammatory process in the gastrointestinal tract.
The single arm, open label pilot study with mild to moderate ulcerative colitis will have Travelan added to their current treatments. Any beneficial therapeutic effects of Travelan will be assessed through the use of widely accepted disease activity markers.
The study is to run over approximately 6 months, with results expect by the end of the 2006/07 financial year.
Market Size
Currently there are over 70,000 people with IBD in Australia, while between 1 and 1.4 million people in the United States and 2.2 million people in Europe suffer from these diseases.(Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: Incidence, prevalence, and environmental influences. Gastroenterology. 2004 May; 126(6): 1504-17.)
Other chronic diarrhoea diseases such as Irritable Bowel Syndrome have significantly larger markets10-20% of the world's population have symptoms associated with IBS, with predominance in women.

About Inflammatory Bowel Disease: (IBD)
Inflammatory bowel disease is the collective term given to two conditions, namely ulcerative colitis and Crohn's disease. These two disorders, primarily of the lower gastrointestinal tract (large bowel or colon) are characterised by inflammation of the intestine resulting in abdominal pain, diarrhoea (often bloody) and weight loss. The cause of both conditions is unknown although there is increasing evidence that dysfunction between the patients' immune system and the gut flora may play a role in continuing disease activity.
For more information about IBD visit www.thegutsygroup.com.au/
Scientific basis for Travelan in IBD
The scientific basis for using Travelan as a therapy in IBD relates to "hyper-immune" polyclonal antibodies being able to bind to bacterial wall products. Some of these products are believed to continue the persistent inflammation of the gastrointestinal tract that occurs in these conditions.
Travelan - Natural and Effective
Travelan, a natural, clinically proven therapy is a revolutionary over-the-counter (OTC) preparation scientifically and clinically proven to significantly reduce the risk of getting the medical condition known as travellers' diarrhoea and reduce the symptoms of minor gastrointestinal disorders.
Travelan is prepared from naturally derived polyclonal antibodies against 13 strains of E.coli that are the most common cause of travellers' diarrhoea. Travelan is high in antibodies that bind to certain intestinal bacteria and bacterial by-products, and is a not an antibiotic preparation - therefore not associated with the usual negative antibiotic side effects.
Travelan is a natural product enabling travel with reduced fear of becoming ill due to exposure to E. coli bacteria. In hospital clinical trials in the US and Europe, Travelan has shown up to 90% protection against Enterotoxigenic $E$ . coli (ETEC), the main cause of Travellers' Diarrhoea.
Travellers Diarrhoea
Travellers' diarrhoea (otherwise known as Delhi Belly, Montezuma's Revenge, Tourist Trots and The Flux etc) is described as the number one health problem for international travellers, in terms of frequency and economic impact. Travellers' diarrhoea is normally accompanied by other clinical features such as nausea, bloating, abdominal cramps and fever. Travelan significantly reduces the risk of being affected in the first instance.


Visit our websites: www.anadis.com.au and www.travelan.com
Anadis - Delivering On The Promise Of Biotechnology

About Anadis Limited:
Anadis, a Melbourne based biopharmaceutical company is focused on Nutraceutical and Pharmaceutical research and development. Anadis is a specialist in the development of bovine colostrum derived products for therapeutic use in humans. Projects include:
Anadis' first commercialised product: Travelan is a natural product, which significantly decrease the risk of the medical condition known as Travellers Diarrhoea and the symptoms of gastrointestinal disorders. Travelan is a colostrum preparation, against the common strains of $E_{\text{col}}i$ – the most common cause of Travellers.
Travelan has received a "Green Light' for sales in the US and a distributor in Canada has been appointed. Travelan is being considered for other markets including: Singapore, India, Korea, United Arab Emirates, Thailand, Malaysia. South Africa and the UK and EU.
Travelan has recently been potentially identified for additional gastrointestinal indications including Irritable Bowel Syndrome IBS and Inflammatory Bowel Disorder IBD.
For more information please visit www.travelan.com
EV-71 - a bioactive protein based preventative product against Enterovirus 71, a debilitating polio like disease, is one of the viruses that causes 'hand, foot and mouth' or 'slapped cheek' disease. A significant proportion of younger children effected can develop nervous signs such as fits, paralysis and Enterovirus 71 has the potentially to be fatal. Anadis is now preparing colostrum antibodies for commercialisation in an anti-EV71 preventative, set to begin marketing in Taiwan during the northern hemisphere summer of 2007.
A set of Bio-Defence and Respiratory Protection technologies, a project in conjunction with the Australian Department of Defence and US Bio-Defence Organisations, initially focused on short-term immediate protection from airborne bacteria such as Anthrax and Plague, future civilian applications include Hay Fever and Asthma.
This project is expanding to examine the use of antibodies in providing respiratory protection against Influenza virus
Bio-Shield 10 a range of "bio-shielding" technologies which protect delicate molecules, enzymes and proteins, initially targeted for use in the pro-biotic market.
Development into an Immune Stimulating Infant Formula is underway, initially destined for the Asian market.
Pyloran, which has been clinically proven to reduce levels of H.pylori bacteria in the stomach and reduce the symptoms of H.pylori associated gastritis - Anadis is also in early development of a H.pylori vaccine.
For further information, please contact:
Conor Graham - Chief Executive Officer Email: [email protected]$ +61 3 9358 6388 Arie Nudel - Investor Relations Email: [email protected] +61 3 9358 6388
