Generex Biotechnology Corporation's, wholly owned immunotherapeutics subsidiary, Antigen Express Inc., concluded a positive pre-investigational new drug application (IND) meeting with the US Food and Drug Administration (FDA) regarding plans for the commencement of clinical trials of the proprietary and innovative Antigen Express vaccine to protect against the H5N1 avian influenza.

As a consequence of the pre-IND meeting, Antigen Express has clarified the development path (including clinical study design) and regulatory timetable for its innovative vaccine. Prior to the submission of its IND, Antigen Express will conduct a toxicology study and a pre-clinical study to establish the vaccine's dosing regimen, states the company release.

"We are very pleased with the outcome of our meeting with the FDA. 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," said Dr. Eric von Hofe, president, Antigen Express.

The Antigen Express avian influenza vaccine is based on a platform vaccine technology presently in human clinical trials in the form of a breast cancer vaccine. The breast cancer vaccine clinical trials are being undertaken at Walter Reed Army Medical Centre (WRAMC), and a representative of WRAMC participated in this avian flu vaccine Pre-IND meeting with Antigen Express.

The Antigen Express vaccine is designed to induce a strong T-helper cell response using a synthetically manufactured peptide. A strong T-helper cell response plays a major role in helping the body to develop neutralising antibodies to viral infections. Because the vaccine can be manufactured synthetically, it will be less expensive than cell-culture or hen-egg produced vaccines and it is possible to produce it in much larger quantities and much quicker using 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 in prime/boost regimens. The study will also attempt to establish whether application of the vaccine on its own will provide a significant degree of protection in humans who have received no other vaccination.