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Immuron Ltd — Regulatory Filings 2008
Nov 25, 2008
35121_rns_2008-11-25_eddfa944-73a8-4d10-9d48-eb511f53faf2.pdf
Regulatory Filings
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Recent results of the Anadis Influenza program to be presented at the 38th Annual Conference of the Australasian Society of Immunology in December 2008 at the National Conference Centre in Canberra.
Wednesday 26 November 2008
A team from the University of Melbourne, led by Professor Lorena Brown will present at the National Conference Centre in Canberra : “ANTI-INFLUENZA IgG AND F(ab’)2 PRODUCED FROM HYPERIMMUNE BOVINE COLOSTRUM FOR THE PROPHYLAXIS AND TREATMENT OF INFLUENZA INFECTION.”
The presentation summarizes the latest results of research conducted at the Department of Microbiology & Immunology, The University of Melbourne, using the Anadis’ Flubody (www.flubody.com). The study concluded that, as the current influenza vaccine is not administered to the entire population and is less than 100% efficacious in the vaccinated target groups; therapeutic antibodies topically applied to the mucosal surface could provide a significant additional tool to control influenza within the community.
Dr. Oren Fuerst, VP Business development of Anadis stated: “The results are highlighting the commercial potential of our Flubody intellectual property and know-how. For the first time, there are commercially available antibodies against flu that could be manufactured in large scale and at low cost. This would allow for the introduction into the market of preventive and therapeutic solutions based on our Flubodies. The current global market for prevention and treatment of flu and cold is around $10Bn, and together with commercial partners, we plan to become a significant player in this market. We are currently in discussions with potential partners and hope to announce in the coming months such partnerships. Given the excellent safety profile of the colostrum-based platform, we plan to initiate efficacy clinical trials within less than a year”.
The Study
In the study, IgG (antibody) and F(ab’)2 (antibody fragment) were purified from the hyperimmune colostrum of cows vaccinated with influenza A/Puerto Rico/8/34 (PR8) vaccine and shown to have very high hemagglutination-inhibitory and virus-neutralizing titres. The IgG preparation was tested for its therapeutic potential in BALB/c mouse models of upper and total respiratory tract (RT) infection by influenza. A single 50µg dose of anti-PR8 IgG administered to the nose one day after the establishment of an upper RT infection markedly reduced the levels of virus in the nasal turbinates. At the peak of viral replication (day 3 post-infection), anti-PR8 IgG-treated mice had 100-fold lower viral titres compared to an untreated group. With a larger dose (200µg), complete clearance of virus from the nose could be seen in 30% of treated animals. Anti-PR8 IgG was also effective in reducing viral loads in the lungs when given one day after a total RT infection. Complete pulmonary protection was observed in 60% of animals given a
AUSTRALIA L1 39 Levenson St, North Melbourne, VICTORIA, 3051
USA The Empire State Building 350 Fifth Avenue 59th Floor New York, N.Y. 10118
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single dose of 500µg IgG and doubling of this dose resulted in complete clearance in all animals.
In an experiment involving challenge with a lethal dose of PR8 virus, mice treated with non-immune colostrum-derived IgG or F(ab’)2 were culled by day 7 after showing rapid weight loss and severe clinical signs. Mice given a single dose of anti-PR8 IgG or F(ab’)2 showed no weight loss and the virus infection remained subclinical. These observations suggest that a novel and commercially-scaleable technique for preparing antibody from hyperimmune bovine colostrum is capable of providing preparations with significant protective activity post-exposure.
Anadis Limited (ANX.AX; ANDIY.PK; CUSIP: 032517104) is a biopharmaceutical company focused on antigen-primed, dairy-derived health products. Anadis’ proprietary and low-cost antibody manufacturing technology enables it to rapidly develop polyclonal antibody and other protein-based oral therapies to a range of important infectious and immune- mediated diseases.
Contact:
Dr. Oren Fuerst- VP, Business Development Email: [email protected] Tel +1 646 259 3321
Arie Nudel- Investor Relations Email: [email protected] Tel: +61 3 9014 4880
AUSTRALIA L1 39 Levenson St, North Melbourne, VICTORIA, 3051
USA The Empire State Building 350 Fifth Avenue 59th Floor New York, N.Y. 10118