TORONTO -- Generex Biotechnology Corporation (NASDAQ: GNBT), announced today the presentation on October 27th by Nikoletta Kallinteris, the Antigen Express Project Leader, Ii-Key Hybrid Technology who preformed these studies, at the Seventh International Anticancer Conference in Corfu, Greece. Antigen Express is a wholly-owned subsidiary of Generex. 

Nikoletta Kallinteris presented: "Ii-Key/Melanoma gp100(46-58) MHC class II epitope peptide vaccine primes CD4+ T-helper cells in HLA-DR4 transgenic mice." This presentation summarized work on a novel concept in melanoma vaccination by Antigen Express scientists during the past year in a specialized mouse model for melanoma vaccine. These transgenic mice contain the human HLA-DR molecules, which presented the vaccine peptides to the mouse T helper cells. This is an advanced preclinical model, offering support for an IND filing for clinical trials.

Cancer clinicians in many academic cancer centers have shown that peptide vaccines offer hope for immunotherapies in patients with established and potentially recurrent cancers. Melanoma is one of the most advanced models for identification and use of such peptide vaccines. Many vaccine peptides have been developed for stimulation of patients' cytotoxic T lymphocytes to kill cancer cells. However, clinical trials with such vaccine peptides do not demonstrate particularly robust results.

The reason for this lack of potency stems in part from the fact that those vaccine peptides do not boost T helper cells, which up-regulate the cytotoxic T lymphocytes and provide long-term immunological memory.

The mechanism used by Antigen Express scientists to stimulate T helper cells has been to create a hybrid linking the peptide recognized by T-helper cells through a simple chemical linker to an immunoregulatory segment of the Ii-protein (the Ii-Key peptide). Such Ii-Key peptide linked - epitope peptide hybrids are presented 200 times more effectively than the epitope-only peptide in vitro. Immunized mice demonstrated a 4-6 times enhancement of Th1 cells by Ii-Key/antigenic epitope HIV hybrids than HIV epitope-only peptides as measured by an immunological assay specific for T-helper cells.

Applying these methods to melanoma, Antigen Express scientists found similar results with Ii-Key hybrids containing melanoma epitopes. The enhancement of T helper activation probably augments cytotoxic T lymphocyte activity by stimulating dendritic cells. Thus, Ii-Key/melanoma hybrids for T helper cells can be used in combination with cytotoxic T lymphocyte epitope peptides for maximal clinical therapeutic effect.

The potency of other kinds of vaccine peptides is also greatly increased when linked to the Ii-Key active molecule. Antigen is pursuing programs for the use of such vaccines for HIV, SARS, and smallpox as well as breast, colon and ovarian carcinomas.

Antigen Express has received 9 grants from the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, and the Department of Defense for the development of these compounds for many vaccine and treatment purposes.

About Generex

Generex is engaged in the research and development of drug delivery systems and technology. To date, it has focused on developing a platform technology for the buccal delivery -- delivery to the oral cavity for absorption through the inner mouth mucosa -- of drugs that historically have been administered only by injection. Generex's buccal delivery technology has application to a large number of drugs.

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