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Immuron Ltd — Regulatory Filings 2009
Jan 12, 2009
35121_rns_2009-01-12_939513ee-d1c1-44b0-84b1-5a4c5a14f4a8.pdf
Regulatory Filings
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IMMUr©N
Fax Company Amourcement 'From: To: Pages: Fax: Date: Phone: CC. following بعضيضك Re: □ Please Recycle E Please Reply El Piease Comment $\square$ Urgent □ For Review Title: Clinical fried approved in USA for Immuran's adjunctive sharapy for HIV.
ABN 80 063 114 045 AUSTRALIA Level 1, 39 Leveson Street North Melbourne VIC 3051 Tel (61) 3 9018 4880 Fax (61) 3 9018 4881
USA The Empire State Building 350 Fifth Avenue 59th Floor New York, N.Y. 10118 Tel 646 402 5289 Fax 646 390 3238
-357
IMMUre
Formally Anadis Limited
13 January 2009.
The Manager The Company Announcement Office Australian Stock Exchange Limited Sydney, NSW
Dear Sir,
Clinical Trial approved in USA for Immuon's adjunctive therapy for HIV
Attached is an announcement in respect of the approval of a Phase 2 human clinical study in HIV/AIDS patients at a US AIDS research centre. The announcement also contains information about the winning of a research grant with University of Melbourne to further develop further antibody products in the area of HIV control.
Yours faithfully
Dr Grant Rawlin General Manager, VP, Research and Development
ABN 80 063 114 045 AUSTRALIA Level 1, 39 Leveson Street North Melbourne VIC 3051 Tel (61) 3 9018 4880 Fax (61) 3 9018 4881
USA The Empire State Building 350 Fifth Avenue 59th Floor New York, N.Y. 10118 Tel 646 402 5289 Fax 646 390 3238
www.trovalan.com MAANA IMMUUNNA PART
IMMUr©N
Immuron Ltd. Announces Phase II trial of BioGard in U.S., its oral antibody adjunctive -HIV therapy; wins research grant for an HIV antibody
January 13, 2009
San Francisco and Melbourne, Australia---Immuron Ltd. (ASX: IMC ), a biopharmaceutical company specializing in oral immunotherapy development and antibody manufacturing, announces today approval for a Phase II human clinical study in HIV/AIDS patients at a prestigious U.S. AIDS research center. The announcement was made during the 27th Annual J.P. Morgan Healthcare Conference in San Francisco.
The study is being conducted by the Center for AIDS Research, a prominent NIH funded research program, at Case Western Reserve University. University Hospitals in Cleveland Ohio. The study is led by Professors Gopal Yadavalli, Benigno Rodriguez and Michael Lederman, Associate Director of the Center. The study aims to document the ability of Immuron's BioGard ™ hyperimmune bovine colostrum powder formulation to decrease translocation of gut-derived microbial products and decrease immune activation in patients with early stage HIV infection. BioGard contains a mixture of anti-LPS and other antibodies active at the mucosal surface. The study will begin in calendar Q1 2009 and positive results could open a window to expanded trials of BioGard as part of routine HIV/AIDS therapy regimens.
The study complements a recently announced multi-site clinical trial beginning in Australia examining the product's efficacy in HIV/AIDS patients undergoing intensified therapy for persistent immune activation.
Dr. Zeil Rosenberg, Immuron CEO, stated, "We are thrilled with the interest that the Center for AIDS Research has in initiating this study so rapidly. We are even more hopeful now that our oral antibodies can create a new paradigm for addressing an emerging need in HIV patient care."
Separately, Immuron announces that Associate Professor Damian Purcell, Head of the Molecular Virology Laboratory at the University of Melbourne, working with the Australian Centers for HIV and Hepatitis Virology, has been awarded a research grant by the Australian Department of Health and Aging to develop and test an Immuron produced hyperimmune colostrum powder formulation containing antibodies against HIV envelope antigens. This project will augment a new research collaboration with the US National Institutes for Health (NIH). Dr. Oren Fuerst, VP Business development of Immuron stated: "Our unique technology platform allows for the rapid development of targeted antibodies. In addition to targeting HIV related inflammation, we are now developing antibodies against the virus causing AIDS itself."
Immuron Limited (IMC.AX) (formerly called Anadis) is a biopharmaceutical company focused on antigen-primed, dairy-derived health products. Immuron's proprietary and antibody manufacturing technology enables it to rapidly develop polyclonal antibody and other protein-based oral therapies to a range of important infectious and immunemediated diseases, including Influenza, Oral and GI tract Mucositis, and HIV related inflammation.
Contact:
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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