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Generex Provides Update on Antigen Express Phase II AE37 Breast Cancer Vaccine Trial

WORCESTER, Mass. and TORONTO, Feb. 12, 2014 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (GNBT) today announced that recent results from a Phase II study of a novel cancer vaccine designed to prevent relapse in patients who have had breast cancer corroborate prior results from an interim analysis conducted in October of 2011. The Company plans to disclose full results from the Phase II clinical trial at this year's American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago from May 30 to June 3, 2014.  The ASCO Annual Meeting is the premier annual oncology symposium, bringing together more than 25,000 oncology professionals from a broad range of specialties.  Two abstracts in respect of the results of the Phase II trial have been submitted to the ASCO Annual Meeting; per ASCO rules, the contents of those abstracts are embargoed pending the meeting.

The AE37 cancer vaccine is being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). It is designed to stimulate an immune response against the patient's cancer cells, preventing relapse in patients who have been treated for early stage breast cancer.

The recent analysis is based on data from nearly 300 patients, making this the largest controlled and randomized trial of a breast cancer vaccine trial conducted to date.  While full analysis of the recent results is still in progress, the data corroborate qualitatively the data reported after an interim analysis conducted two years ago.  Specifically, the more prevalent population of breast cancer patients ineligible to receive the drug Herceptin, and particularly those in high-risk groups (e.g., triple negative breast cancer), appear to benefit most from AE37.  Both of these patient populations represent areas of significant unmet need.

"We look forward to sharing details of the latest results from this significant study with the medical community and the pharmaceuticals industry," commented Mark Fletcher, Generex's President & Chief Executive Officer.  "We extend our thanks to the cancer patients and clinical investigators who are participating in this important work."

The immunotherapeutic AE37 is designed to work indirectly by stimulating the patient's immune system to recognize and kill cancer cells.  An advantage of the compound is that it potently activates a subclass of immune cells, known at CD4+ T cells, without sacrificing tumor target specificity.  This subclass has been shown to be critical in generating a robust, long-lasting and effective immune response.  AE37 consists of a fragment of the tumor-associated HER2 protein modified by a proprietary platform technology developed by Antigen Express scientists.

The Company previously has been given the green light by the FDA to submit a protocol for a Phase III study of AE37.  In addition to breast cancer, the Company has also completed a Phase I trial of AE37 in patients with prostate cancer.  Along with cancers of the breast and prostate, a variety of other cancers such as ovarian, colon, and lung cancer similarly express some level of HER2 and may be considered for future AE37 trials.

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.

SOURCE Generex Biotechnology Corporation

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