BioGard™
Description:
Oral, high bioavailability BCP-based formulation with increased concentration of anti-LPS immunoglobulin and other natural bioactives
Indication:To maintain gastrointestinal and immune system health. The product has been formulated particularly to address gastrointestinal inflammatory processes seen in persons with HIV/AIDS and chronic GI inflammatory diseases.
Scientific Background:
Structural and immunological damage to the mucosa of the gastrointestinal tract is a characteristic feature of HIV infection and occurs very rapidly during the acute phase of infection. Recent evidence shows that this mucosal damage also leads to bacterial translocation, which further stimulates the immune cells and amplifies the loss of epithelial integrity of the mucosal barrier (Brenchley and Douek 2008; Brenchley et al. 2006). The process of chronic immune activation is an important mechanism in the pathogenesis of HIV infection, because HIV replicates with maximum efficiency in activated CD4+ cells and subsequently kills these cells. Several bacterial cell wall antigens are recognised as potent triggers of the innate immune system’s “toll-like receptors” (TLR), particularly the lipopolysaccharides (LPS) of gram negative bacteria and flagellins (Gewirtz 2006). Bacterial LPS and flagellins play a central role in triggering and exacerbating the inflammatory response in syndromes such as IBD (Podolsky 2002). The Anadis technology potently tackles bacterial immunotoxins in the gut and could play an important role in reversing the immune activation that drives replication and pathogenesis.
Current Development Status :
-A major 21 site phase IV clinical trial is underway testing BioGard both together with and separate from an already approved highly active anti-retroviral therapy (HAART) by Merck, as part of a combination therapy intensification protocol in treatment experienced HIV/AIDS patients
Oral, high bioavailability BCP-based formulation with increased concentration of anti-LPS immunoglobulin and other natural bioactives
Indication:To maintain gastrointestinal and immune system health. The product has been formulated particularly to address gastrointestinal inflammatory processes seen in persons with HIV/AIDS and chronic GI inflammatory diseases.
Scientific Background:
Structural and immunological damage to the mucosa of the gastrointestinal tract is a characteristic feature of HIV infection and occurs very rapidly during the acute phase of infection. Recent evidence shows that this mucosal damage also leads to bacterial translocation, which further stimulates the immune cells and amplifies the loss of epithelial integrity of the mucosal barrier (Brenchley and Douek 2008; Brenchley et al. 2006). The process of chronic immune activation is an important mechanism in the pathogenesis of HIV infection, because HIV replicates with maximum efficiency in activated CD4+ cells and subsequently kills these cells. Several bacterial cell wall antigens are recognised as potent triggers of the innate immune system’s “toll-like receptors” (TLR), particularly the lipopolysaccharides (LPS) of gram negative bacteria and flagellins (Gewirtz 2006). Bacterial LPS and flagellins play a central role in triggering and exacerbating the inflammatory response in syndromes such as IBD (Podolsky 2002). The Anadis technology potently tackles bacterial immunotoxins in the gut and could play an important role in reversing the immune activation that drives replication and pathogenesis.
Current Development Status :
-A major 21 site phase IV clinical trial is underway testing BioGard both together with and separate from an already approved highly active anti-retroviral therapy (HAART) by Merck, as part of a combination therapy intensification protocol in treatment experienced HIV/AIDS patients
(see company press releases regarding the study, CORAL).
-A
clinical trial by the Center for AIDS Research, a prominent NIH funded
research program, at Case Western Reserve University. University
Hospitals in Cleveland Ohio. Has been approved by the University IRB
and will begin shortly. 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 (See company press release regarding the study).