GENEREX TO BEGIN HUMAN TRIAL OF PANDEMIC FLU VACCINE

Generex Biotechnology announced that 50 volunteers have been selected for participation in human clinical trials of the synthetic avian influenza vaccine under development by its wholly owned subsidiary, Antigen Express. The company previously entered into an agreement with a hospital in Lebanon to conduct the Phase I trial. The trial will enroll a total of 160 patients.

Antigen Express' technology has particular advantages for use against potentially pandemic H5N1 avian influenza virus in that a peptide vaccine could be made in much larger amounts, more rapidly and less expensively than the more traditional egg-based vaccines. Currently, it would be possible to vaccinate only a small fraction of the U.S. population using egg-based vaccines, according to the company.

The technology entails modifying a small fragment of the hemagglutinin protein from the H5N1 virus to more potently stimulate CD4+ T helper cells. The antigen-specific stimulation of T helper cells has been shown to be crucial in establishing immunity to foreign agents. This type of T helper stimulation is expected to augment the activity, and hence number of people, that could be immunized with a traditional egg-based vaccine as well as to protect against the lethality of the H5N1 virus when used alone.