Anadis to use its polyclonal antibodies for treatment

A research-driven biotechnology company  today announced plans for a clinical study to demonstrate the prevention of gastrointestinal damage caused by typical cancer treatments

MELBOURNE, Australia | August 16, 2007 |
Anadis Ltd. (ASX:ANX), a research-driven biotechnology company focused on the use of polyclonal antibodies for the treatment and prevention of major diseases, today announced plans for a clinical study to demonstrate the prevention of gastrointestinal damage caused by typical cancer treatments.

This new research program successfully leverages Anadis investment in its Travelanä program (for travellers diarrhoea) into a market with significant potential growth as an adjunctive cancer treatment.

The new clinical study will demonstrate the impact of Anadis orally-administered polyclonal antibody formulation on Chemotherapy-Related Mucositis, a major clinical problem in cancer patients characterized by intestinal tissue destruction throughout the gastro-intestinal tract, including painful mouth ulcerations (Oral Mucositis).

Seen in approximately 40% of chemotherapy patients, Chemotherapy-Related Mucositis usually occurs within two weeks of initiation of many chemotherapy regimens. Mucositis can lead to dysphagia (painful swallowing),
weight-loss, infection, and sepsis (from bacteria such as E.coli which leak from the intestine). It is a leading cause of discontinuation of chemotherapy treatment. Radiation therapy is also a recognized cause of mucosal damage leading to the inflammation and ulceration from Mucositis.

The global Mucositis market is large and there is currently no dominant or broadly effective treatment for either Oral Mucositis or Gastro-Intestinal Mucositis. In the USA more than 1 million patients undergo chemotherapy annually, receiving an average of four months? treatment each. More than 1 million patients undergo radiation treatments annually for an average of two months each, including time to resolve gastro-intestinal side-effects.

Prevalence of Mucositis varies across treatments, ranging from a low of 12% in patients receiving adjuvant chemotherapy to 99% in patients receiving bone marrow transplant. Other estimates indicate a range of more than 50% in patients on high-dose chemotherapy or those with leukemia, 21%-31% in patients with solid tumors, and 60%-90% in patients with head and neck cancer receiving standard chemotherapy and radiation therapy.

The market outside the USA is estimated to be at least as large, with similar Mucositis rates. There are only a few solutions for these severe problems, with one of the main solutions being a recently released drug (approved for only limited indications) priced at $6,000-$8,000 per regimen. The Anadis product for Mucositis is expected to offer broad applicability and is planned to be marketed as a medical food.

Anadis clinical studies will be undertaken at several major cancer centers in Israel, led by cancer specialists at the Sheba Medical Center and the Sourasky Medical Center, both in Tel Aviv, Israel. The study will be
completed during 2008.

Dr Zeil Rosenberg, CEO of Anadis, said: ?Anadis expects to become a world leader by providing an effective solution in the Mucositis market. Our product could reach the market within 3-5 years. The cancer treatment-induced Mucositis market represents a major cause of morbidity and loss of quality of life for cancer patients. Our solution could save lives. This is an example of an ambitious research and development plan that relies on our proven technology platform, developed over more than a decade. The Mucositis program also benefits tremendously from the know-how alreadyincorporated in our E.coli prevention product, Travelanä.

Anadis Ltd. (ASX: ANX) is a biotechnology company focused on antibody-based therapeutic and preventive products with a product pipeline addressing existing market opportunities sized in excess of US$30 billion. All products in the company's pipeline are expected to reach the market over the next five years Current research and development pipeline targets address broad markets including influenza, Oral Mucositis, nosocomial infections, entericdiseases, biodefence, functional foods and oncology.

Anadis proprietary rapid development and manufacturing technology, the HIDDA platform (Hyper-Immune, Dairy-Derived Antibodies) provides Anadis with significant competitive advantages in the development of proprietary polyclonal antibody-based solutions to a broad range of infectious and immune-mediated diseases.

Short Time to Product: May require as little as 3-6 months to obtain new antibody formulations for clinical testing and use.

Rapid Scale up: With access to significant numbers of dairy animals, large-scale rapid production is feasible and cost-effective.

Cost Advantage: Dairy-derived immunoglobulins are a fraction of the cost of serum-derived monoclonal antibodies and may provide a more robust immune response.

Shorter Regulatory Pathway: The antibodies are purified and formulated from colostrum (first-milking) of dairy cows which have been immunized with proprietary vaccines and then carefully tracked for safety. Anadis HIDDA-based pipeline products are typically classified as medical food and have a much shorter and less costly path to commercialization than comparable pharmaceutical products.

Platform based: Proven ability to raise and harvest a broad range of antibodies against bacteria, viruses and toxins for delivery to the gastrointestinal tract, the upper respiratory tract and topically as required. Leveraging a technology platform that has been developed over a decade by leading medical research institutions, Anadis expects to become
the leading provider of proprietary polyclonal antibody-based solutions worldwide within five years.

Pipeline: Target markets exceed US$30 billion and include both proprietary products the company plans to manufacture itself, as well as out-license, respectively. The pipeline is expected to reach the market over the next five years:

--  Influenza. Immediate-acting prevention and treatment of pandemic and seasonal influenza. The Anadis HIDDA platform allows for rapid modifications of the antibody profile in order to address new, emerging strains (eg avian
influenza). Access to a specialized government high containment research unit including highly lethal H5N1 avian influenza strains will aid rapid product development.

--  Oral Mucositis A common and potentially serious side effect of high-dose chemotherapy (CT) and/or radiotherapy (RT) regimens often manifested as painful ulcerative lesions of the mouth and throat. Target market includes more than 5 million patients.

--  Bio-Defense-Environmental pathogen diagnosis, containment decontamination. Funded by the Australian Defence Department?s Science and Technology Office (DSTO), this emergency response system is based on a proprietary antibody/ polymer hydrogel combination for the rapid identification and containment of anthrax, plague and other bio-warfare agents.

--  Nosocomial infections Prevention and treatment for top priority hospital and community acquired nosocomial infections, in particular Clostridium difficile.

--  Enteric disease conditions including:

--  Travellers Diarrhoea (TD) (enterotoxigenic E.coli). This product, Travelan, was introduced to the market as a proof-of-concept of the platform and is being sold in Australia, Canada and other countries

--  Irritable bowel syndrome (IBS), suffered by more than 10% of the world's population.

-- Inflammatory bowel disease (IBD) A clinical study for use as an adjunct therapy in patients with IBD started in 2007 and is being expanded to a multi-center study.

--  Functional Food HIDDA permits freeze-drying of proteins and vaccines onto dry food enabling use of dairy-derived antibodies as functional food. Anadis has announced a research and development collaboration with Coca Cola Amatil Australia to commercialize derivatives of the technology.

--  Oncology Anadis is in final stage of negotiations with several major cancer research groups to develop HIDDA based oncology treatment approaches, initially addressing liver cancer.

--  BioShielding- Proprietary oral drug delivery technology Originally developed for Anadis own products, this approach protects orally administered and pH sensitive drugs, antibodies and vaccines from degradation during passage through the harsh acid conditions found in the stomach, facilitating absorption or immunization in the gut. This technology may allow reformulation of numerous products already in the market, increasing their efficacy or permitting oral delivery.


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