Generex Announces Publication of Studies with the Mayo Clinic Confirming and Extending the Antigen Express Ii-Key Platform Technology

Generex Biotechnology Corporation

announced today the publication of studies conducted at the Mayo Clinic using the Antigen Express proprietary Ii-Key technology. Antigen Express, Inc., the Company's wholly-owned subsidiary, has used this technology platform in the development of self-potentiating immunotherapeutic vaccines for cancer. AE37, an Ii-Key HER-2 hybrid, is currently the subject of a controlled, randomized, and single-blinded Phase II clinical trial in patients with HER-2 expressing breast cancer. The publication, entitled "MHC Class II Epitope Nesting Modulates Dendritic Cell Function and Improves Generation of Antigen-Specific CD4 Helper T Cells," was published in the peer-reviewed Journal of Immunology (www.jimmunology.org). A significant finding of the report, conducted in a mouse model, was that specific CD4+ T cell (T-helper) activation by Ii-Key hybrids excludes T regulatory (immune suppressor) cells. T regulatory cells (immune suppressor) may hinder active immunotherapy of cancer. The lack of activation of this cell type has been observed previously in clinical studies of AE37 (an Ii-Key-HER-2 hybrid), both in breast as well as prostate cancer patients.