Generex subsidiary to file New Drug Application for avian flu vaccine

By Lisa Kerner

Erie, Pa., Jan. 23 - Generex Biotechnology Corp. said its wholly owned immunotherapeutics subsidiary, Antigen Express, will meet with the Food and Drug Administration on Feb. 10 to discuss filing an Investigational New Drug Application and the start of human clinical trials.

The application is for the novel Antigen Express vaccine to protect against the H5N1 avian influenza, according to a company news release.

Current estimates are that the total production capacity of the world for producing an avian flu vaccine using traditional methods is less than 40 million doses, at the cost of several hundred million dollars, according to the news release.

Scientists at Antigen Express are developing a vaccine for the potentially pandemic Asian bird flu (H5N1 strain) using highly conserved fragments of the H5 protein to stimulate potent T-helper cell activity.

A strong T-helper response plays a major role in helping the body to develop neutralizing antibodies to viral infections, the company said.

The induction of a good T-helper response is expected to greatly reduce the amount of classically produced vaccine needed for protective immunity. The Ii-Key/H5 vaccine hybrids could also afford significant protection in humans who have received no other vaccine.

Because the Ii-Key/H5 hybrids can be manufactured synthetically, they are less expensive than cell-culture or hen-egg produced vaccines. As a result, they can be produced in larger quantities more quickly in existing facilities.

Toronto-based Generex is engaged in the research and development of drug delivery systems.

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