Sep 4 2008
Anadis announced today its commercialization of a new product, BioGard, intended to maintain gastrointestinal and immune system health. The specific formulation may be of particular clinical benefit in persons undergoing antiretroviral therapy for HIV/AIDS.
The product is intended to enhance current treatment regimens and improve the efficacy of immune system repair during highly active antiretroviral treatment (HAART) treatment. The gastrointestinal immune system is increasingly recognized as having an important role in the progression of HIV-related immune depletion and local gastro-intestinal symptoms have been a great concern to HIV/AIDS patients. The target market for the product includes over 1 million patients in the U.S., 2 million in Europe and Central Asia and more than 30 million worldwide. BioGard is intended to be marketed as a medical food, used under medical supervision, although available for purchase over-the-counter, and is expected to be launched in 2009 following results from a phase IIIb/IV multi-site clinical trial beginning this year that is an advanced stage of planning.
The product's active ingredient is a proprietary oral formulation of antigen-targeted Bovine Colostrum Powder (BCP) that has been approved by Australia's regulatory agency, the Therapeutic Goods Administration (TGA). The product will be first available in tablet format manufactured and packed in a TGA registered GMP tableting facility. Like other Anadis BCP products, the freeze-dried active ingredients in BioGard tablets is obtained from commercial dairy cow herds utilizing the patented Anadis hyper-immunization technology and deploying unique collection processes to assure quality . The BSE free cows in these herds, as well as being vaccinated for routine cattle pathogens, have been vaccinated with a proprietary Anadis vaccine containing important lipopolysaccarides found in gram negative bacterial cell walls that are implicated as key drivers of AIDS pathogenesis. Data supporting this work was first presented recently by scientists from Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria and the Department of Microbiology & Immunology, University of Melbourne at the Australian Society for Microbiology annual meeting held in Melbourne.
Anadis is now in advanced discussion with a major AIDS-research institution to test the efficacy of BioGard in a multi-site, randomized double-blind, placebo controlled study. The goal of the study is to measure the effect of combination antiretroviral therapy intensification with BioGard on CD4+ outcomes in HIV-1 infected individuals with suboptimal CD4 response to therapy despite prolonged virologic suppression.
Details of the study will be released at a later time.
Dr. Zeil Rosenberg, CEO of Anadis stated: "Combination anti-retroviral therapy (cART) intensification and use of our new antigen-targeted bovine colostrum added to stable cART may help restore immunological integrity of the intestinal mucosal barrier thereby controlling microbial translocation, diminishing immune activation and resulting in better CD4+ cell reconstitution. This is expected to significantly improve the efficacy and safety profile of drugs in the HIV area."
Dr. Oren Fuerst, VP Business Development of Anadis, stated: "BioGard was developed based on a novel approach related to the inflammation process and is another manifestation of the versatility of our platform. We continue to develop and rapidly commercialize products that are both important to large populations and which have a clear commercial market. In this case, our products may increase the efficacy and safety of drugs with current revenue in excess of $5bn per year."
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