Generex Biotechnology Corp. announced publication of a follow-up study from a Phase 1 clinical trial of the immunotherapeutic agent AE37 in patients with prostate cancer. The study demonstrates an association between a specific immune response generated by AE37 and improved overall survival. The compound is being developed by Antigen Express Inc., a wholly-owned subsidiary of Generex, for multiple cancer indications.

 

The publication, entitled, “AE37 peptide vaccination in prostate cancer: identification of biomarkers in the context of prognosis and prediction,” appears in the peer-reviewed journal Cancer Immunology, Immunotherapy, a forum for new concepts and advances in basic, translational, and clinical cancer immunology and immunotherapy. While a prior study showed that AE37-immunized patients had better overall and disease-free survival as a group than would be expected from their disease status, the current study shows that patients with the strongest immunological response did the best. In particular, both the presence of AE37-induced T cells in peripheral blood as well as a robust delayed type hypersensitivity (DTH) response elicited by AE37 correlated significantly with overall survival. The authors point out the importance of CD4+ T cells in developing a good DTH response. AE37 was developed using the Antigen Express Ii-Key technology platform that ensures robust, specific CD4+ T cell activation. 

 

The current report expands upon prior studies on the results of a Phase 1 trial of AE37 in patients with prostate cancer. AE37 is also the subject of a controlled, randomized Phase 2 trial to prevent recurrence in patients who have had breast cancer. That study has shown an encouraging trend toward preventing relapse, particularly in patients with low levels of HER2 expression and in triple negative patients. The search for reliable biomarkers is a key priority in the emerging field of cancer immunotherapy. The current study makes important contributions toward that aim while supplying compelling data for the further developmental of AE37.

 

Date: August 6, 2014

Source: Generex Biotechnology