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www.fdanews.com/articles/88665-firm-to-begin-testing-bird-flu-vaccine-in-lebanon

FIRM TO BEGIN TESTING BIRD FLU VACCINE IN LEBANON

November 8, 2006

Generex Biotechnology announced it has entered into an agreement with the Lebanese-Canadian Hospital in Beirut to conduct a human clinical trial of Antigen Express' synthetic avian influenza vaccine, representing the first studies of the vaccine to be conducted in humans. The study has been approved by the appropriate Lebanese governmental and regulatory bodies.

Antigen Express, a wholly owned subsidiary of Generex, designed the vaccine using its proprietary platform technology and has been conducting preclinical studies since 2004. The vaccine is based on simple peptide-synthesis technology, so it can be manufactured rapidly, easily and inexpensively, according to Generex. This is in sharp contrast to traditional egg-based vaccines that rely on biological systems for vaccine production, making their availability to at-risk populations during a pandemic extremely limited, the company said. Preclinical studies suggest the synthetic vaccine may also be used with more traditional vaccines to extend their utility.

The vaccine consists of specific fragments of the H5 protein from the H5N1 influenza virus that have been modified to enhance their potency in stimulating CD4+ T helper cells. Flu-specific T helper cells have been shown to be essential in the development of a robust, protective immune response against influenza, according to Generex.