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Immuron Ltd — Regulatory Filings 2008
Sep 2, 2008
35121_rns_2008-09-02_d10f0abf-ca55-4cb5-8f48-d7c2d7694d5f.pdf
Regulatory Filings
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Clinical Trial Protocol Against Cancer Therapy Side Effects (Mucositis) Approved
Wednesday 3 September 2008
MELBOURNE, Australia‐‐(BUSINESS WIRE)‐‐Anadis Ltd. (ASX:ANX; OTC:ANDIY) an Australian biopharmaceutical company specializing in oral immunotherapy using naturally derived antibodies and other proteins is announcing the clinical protocol for its Cancer‐related Mucositis Program was cleared by the Tel Aviv Souraski Medical Center’s Institutional Review Board (IRB) and by the Israeli Ministry of Health (MOH). This enables the initiation of the clinical trial addressing this significant target at the medical center within a month.
Mucositis is a significant side effect in cancer therapy (between 20% and 100% of patients, depending on the type of cancer and treatment). It is characterized by intestinal tissue destruction throughout the GI tract, including painful mouth ulcerations and severe gastrointestinal symptoms interfering with nutrition and treatment. There are currently no effective treatments for GI Mucositis available in the marketplace and treatment for Oral Mucositis is very expensive and limited to a narrow group of eligible patients. In the U.S. alone there are more than 10 million patients undergoing cancer treatments and 1.5 million new cancer cases each year.
The intended product, primarily for the oncology market, will leverage a unique formulation of Anadis' immune milk‐derived anti LPS antibodies, growth factors and other bioactives combined and delivered using Anadis’ patented oral delivery technology. Anadis anticipates a commercial product could reach the market within 2‐3 years, due to the product’s excellent safety profile.
Anadis recently announced the receiving a significant grant (see “Anadis Awarded VISTECH grant for Clinical Trial of Polyclonal Antibodies for the Treatment of Cancer Related Mucositis” July 1, 2008) to help fund this important program.
Keyword Tags: antibodies, cancer, milk, mucositis, oncology, polyclonal antibody
For further information contact:
Dr. Oren Fuerst‐ VP, Business Development Email: [email protected] Tel +1 646 536 9289
Gran Rawlin – VP, Research and Development Email: [email protected] Tel: +61 3 9018 4880
Arie Nudel‐ Investor Relations Email: [email protected] Tel: +61 3 9018 4880
Anadis Limited (ASX: ANX; OTC: ANDIY) is a biopharmaceutical company focused on antigen‐primed, dairy‐derived health products. Anadis’ proprietary technology enables rapid development of polyclonal antibody and other proteins‐based solutions to a range of important diseases. The all‐natural colostrum‐derived platform, its high safety profile when administered orally and the proprietary methods of manufacturing, allows for short time‐frame from bench to market with high manufacturing scalability.