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Generex Announces Memorandum of Understanding in respect of a Phase II Clinical Trial for the Antigen Express Prostate Cancer Vaccine
Date:10/15/2015

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.

Cautionary Note Regarding Forward-Looking Statements
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.


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