Generex Announces Memorandum of Understanding in respect of a Phase II Clinical Trial for the Antigen Express Prostate Cancer Vaccine

WORCESTER, Mass. and TORONTO, Oct. 15, 2015

WORCESTER, Mass. and TORONTO, Oct. 15, 2015 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) today announced that its wholly-owned immunotherapeutics subsidiary, Antigen Express, Inc. (www.antigenexpress.com), has entered into a Memorandum of Understanding with CompanDX Ltd. to conduct a Phase II clinical trial of the Antigen Express proprietary prostate cancer vaccine.  CompanDX is located in the BioCity business incubator (www.biocity.co.uk) in Nottingham, England.

A number of studies conducted by Antigen Express on its AE37 immunotherapeutic cancer vaccine have shown promising results. Long term follow up of a Phase I study in prostate cancer patients showed that a robust, target-specific immune response persisted in patients for at least three years following treatment. A Phase II study in early stage breast cancer patients showed encouraging results in terms of disease-free survival, particularly in patients who were not eligible for treatment with Herceptin.

CompanDX has established expertise in the biological monitoring of patients and personalized medicine. The importance of monitoring and biomarker identification is paramount in the emerging field of cancer immunotherapy. CompanDX has established a subsidiary, TumourVac, Ltd., for the administration of the Phase II AE37 prostate cancer study.

Antigen Express has developed technology for the specific and robust activation of critical T cell subsets important in generating an anti-cancer immune response. While checkpoint inhibitors have shown great success in treating 20% to 30% of patients with various cancers, it is likely that many of those not responding do not have sufficiently activated T cells to take advantage of the immunosuppression afforded by checkpoint inhibitors and kill tumor cells. The collaboration will yield critical information on the optimization of cancer immunotherapy while advancing the clinical development of AE37.

Under the terms of the Memorandum agreement, milestone payments and royalties will be paid to Antigen Express in exchange for the rights to AE37 for the treatment of prostate cancer.

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™ 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.