Generex Biotechnology Corporation (GNBT) announced that its wholly-owned immunotherapy subsidiary, Antigen Express, Inc., has entered into an agreement with the University of Rochester as part of the Antigen Express efforts to develop a novel vaccine against the potentially pandemic avian influenza.

The collaboration brings together Dr. John Treanor, an internationally recognized leader in the clinical development of pandemic influenza vaccines, and the novel peptide vaccine technology pioneered by Antigen Express. Dr. Treanor is Professor of Medicine, and of Microbiology and Immunology, in the Department of Medicine at the University of Rochester Medical Center.

Antigen Express is involved in the clinical development of peptides designed to potently stimulate CD4+ T helper cells through enhanced interaction with MHC class II molecules. Earlier this year, the company began phase I clinical studies of proprietary peptides derived from the hemagglutinin protein of the H5N1 avian influenza virus in healthy volunteers. The particular value of using modified peptide vaccines for avian influenza is that they can be manufactured by an entirely synthetic process which reduces cost and increases both the speed and quantity of production relative to the traditional egg-based or cell-culture based vaccines. An additional value is that the peptides are derived from regions of the virus that are similar enough in all H5N1 virus strains such that they would not have to be newly designed for the specific strain to emerge in a pandemic.

In addition to a vaccine for avian influenza, the company is also conducting clinical trials of another peptide to stimulate an immune response to a tumour-associated protein in breast cancer patients. That peptide was designed by similar proprietary means to those being used for avian influenza. A phase II breast cancer vaccine trial was initiated the first part of this year based on a successful phase I trial wherein the modified peptide was found to be safe, well-tolerated, and stimulated the desired antigen-specific response as measured in the peripheral blood cells of breast cancer patients.

"We are very pleased to be working with Dr. John Treanor and are looking forward to a productive relationship," said Dr. Eric von Hofe, president of Antigen Express. "He is an outstanding immunologist with extensive experience in the clinical development of avian influenza vaccines."

Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity.