New immune response data from Generex’s AE37 Phase II trial on breast cancer

Generex Biotechnology Corporation (OTCBB: GNBT.OB) announced today that new immune response data from the on-going Phase II clinical trial of the AE37 breast cancer vaccine undertaken by Generex wholly-owned subsidiary Antigen Express, Inc. was presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (https://www.asco.org/) on June 2, 2012 in Chicago, IL.

The abstract entitled: 'An assessment of disease features and immune response in breast cancer patients that did not recur after receiving HER2 peptide, AE37 vaccine in a randomized phase II trial' by Diane Hale, et al, was presented June 2 in the Breast Cancer – HER2/ER session at ASCO. The presentation compared the immunological response in patients who relapsed versus those who did not.  The parameters examined included T cell proliferation and cytokine expression, delayed-type hypersensitivity (DTH) and presence of T regulatory cells.

While all AE37 immunized patients showed increased T cell activation, DTH response and a decrease of T regulatory cells, the strongest predictive association with disease free survival appeared to be a decrease in T regulatory cells, which function to limit the immune response. This is of particular interest given that the AE37 peptide is designed to specifically activate CD4+ T helper cells. An early concern was that T regulatory cells (which are a subset of CD4+ T cells) might also be increased. Their decrease after AE37 immunization has been observed in two Phase I clinical trials as well as in the ongoing Phase II study.

The study confirms prior observations that AE37 has multiple mechanisms of action in generating an anti-cancer immune response, activating T cells to specifically recognize tumor cells while reducing inhibitory immunological responses.  The study, together with interim results showing a trend toward decreased relapse in breast cancer patients receiving AE37, supports advancement to Phase III clinical trials.