Immuron, an Australian biopharmaceutical company specializing in oral immunotherapy development and antibody manufacturing, has received approval for a Phase II human clinical study in HIV/AIDS patients at a US AIDS research center, and the award of a research grant for an HIV antibody.
The study is being conducted by the Center for AIDS Research, a prominent National Institutes of Health-funded research program, at Case Western Reserve University. University Hospitals in Cleveland Ohio. The study is led by Gopal Yadavalli, Benigno Rodriguez and Michael Lederman, associate director of the Center. The trial 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 first-quarter 2009 and positive results could open a window to expanded trials of BioGard as part of routine HIV/AIDS therapy regimens. It complements a recently announced multi-site clinical trial sponsored by the Australian National Center in HIV Epidemiology and Clinical Research examining the product's efficacy in HIV/AIDS patients undergoing intensified therapy for persistent immune activation.
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