Generex has "positive" meeting with FDA on avian flu vaccine

New York, Feb. 13 - Generex Biotechnology Corp. said it has a "positive" pre-Investigational New Drug Application meeting with the Food and Drug Administration about its avian flu vaccine.

Officials discussed the plans of Generex's immunotherapeutics subsidiary Antigen Express, Inc. for clinical trials of its vaccine against the H5N1 virus.

Generex said Anigen Express "has clarified the development path (including clinical study design) and regulatory timetable for its innovative vaccine."

Before submitting its Investigational New Drug Application, Antigen Express will conduct a toxicology study and a pre-clinical study to establish the vaccine's dosing regimen.

"We are very pleased with the outcome of our meeting with the FDA," said Eric von Hofe, president of Antigen Express, in a news release. "We appreciate the extent to which the FDA will be engaged in this process and we look forward to its continuing guidance. We feel that this early intercession with the FDA will streamline our developmental and regulatory processes."

The avian flu vaccine is based on a technology currently being examined in human clinical trials as a breast cancer vaccine. It is designed to induce a strong T-helper cell response using a synthetically manufactured peptide.

Generex is a Toronto-based company working on drug delivery systems and technologies.

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