Generex Announces Publication of Biomarker Studies Related to the Antigen Express Novel Immunotherapeutic AE37 in Prostate Cancer Patients
WORCESTER, Mass. and TORONTO, Feb. 27, 2014 /PRNewswire/ — Generex Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today announced publication of studies examining potential biomarkers associated with overall survival in prostate cancer patients treated with its immunotherapeutic agent AE37. The retrospective study examined data from 29 patients immunized as part of a Phase I study. The immunotherapeutic agent AE37 is being developed by Antigen Express, Inc. (www.antigenexpress.com), a wholly-owned subsidiary of Generex, for multiple cancer indications.
The report, entitled ‘Immunologic biomarkers in prostate cancer: The AE37 paradigm,‘ is being published in the journal Human Vaccines and Immunotherapeutics (May 2014, Volume 10, Issue 5, online publication February 19, 2014), a peer-reviewed journal. A variety of immune related markers were examined for correlation with overall survival. Of particular interest were the findings that AE37-induced immune responses appeared to be stronger in patients with low levels of HER2 expression as well as in patients with earlier stages of disease. In a separate Phase II trial of AE37 in patients with early stage breast cancer, it has been observed that patients with lower levels of HER2 expression appear to benefit most from AE37 immunization. AE37 is designed to elicit an immune response to the HER2 protein, which is expressed at varying levels in tumors of the breast, prostate, ovarian, gastro-intestinal tract, and a variety of other cancers.
The identification of viable biomarkers is of particular interest in the field of cancer immunotherapy as generation of an immune response and subsequent efficacy can be delayed significantly beyond what is observed for conventional cancer therapies. “These studies complement nicely the data from our Phase II trial of AE37 in breast cancer patients,” commented Dr. Eric von Hofe, Ph.D., President of Antigen Express. “They represent an important first step toward a comprehensive search for biomarkers to aid in the development of AE37 and will likely have application to the field of cancer immunotherapy in general.”
About Generex Biotechnology Corporation
Generex is engaged in the research, development, and commercialization 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 (with no deposit in the lungs). The Company’s proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company’s proprietary RapidMist(TM) device. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation technologies in immunotherapy. One focuses on modification of peptides with Ii-Key to increase potency, while a second relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
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SOURCE Generex Biotechnology Corporation