Antigen Express, Generex’s wholly owned subsidiary, will meet with the FDA in February to discuss requirements for the filing of an investigational new drug (IND) application for the novel Antigen Express vaccine to protect against the H5N1 avian influenza and the commencement of human clinical trials.
Scientists at Antigen are developing a vaccine for the potentially pandemic Asian bird flu (H5N1 strain) utilizing highly conserved fragments of the H5 protein to stimulate potent T-helper cell activity. The H5 fragments are modified using a portion of an immunoregulatory protein (termed Ii-Key) that greatly facilitates their ability to stimulate T-helper cell responses specific to the H5N1 strain.
The vaccine peptides have been selected for their likelihood of being both potent and active in more than 80% of the population.
The great advantage of the Antigen vaccine over conventional vaccines is its ability to induce a strong T-helper cell response using a synthetically manufactured peptide. This is important, as a strong T-helper response plays a major role in helping the body to develop neutralizing antibodies to viral infections.
Because the Ii-Key/H5 hybrids can be manufactured synthetically they are less expensive than cell-culture or hen-egg produced vaccines and it is possible to produce them in much larger quantities quicker in existing facilities.
The induction of a good T-helper response is expected to greatly reduce the amount of classically produced vaccine necessary to achieve protective immunity. It is also expected that the Ii-Key/H5 vaccine hybrids will afford some significant degree of protection in humans who have received no other vaccine.