Generex Announces Issuance of Buccal Insulin White Paper

Company Updates Stockholders on Generex Oral-lyn™

WORCESTER, Mass. and TORONTO, Aug. 27, 2015 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) today announced the issuance of a white paper on the status of Generex Oral-lyn™, the Company's proprietary buccal insulin spray product.  The white paper was presented to the August 19, 2015 annual meeting of the Company's stockholders by Dr. James H. Anderson, Jr., MD, the Company's Chief Scientific Advisor.  The white paper may be viewed online on the Generex website.

The white paper builds upon the recently announced success of the Company's initial efforts to enhance the Generex Oral-lyn™ formulation by increasing the concentration of insulin, which efforts were undertaken in concert with the University of Toronto's Center for Molecular Design and Pre-formulations (CMDP) (http://cmdp.uhnres.utoronto.ca) through the University Health Network (www.uhn.ca) and the University of Guelph (www.uoguelph.ca).

The white paper details the Company's pioneering efforts in the design and development of an alternative method for the delivery of insulin into the human body that will allow patients with diabetes to avoid the discomfort and inconvenience of injections whilst not merely preserving, but enhancing, the metabolic effects of the administered insulin.  Unlike inhaled insulin products, Generex Oral-lyn™ does not enter the lungs, thereby avoiding the safety concerns associated with the absorption of a growth hormone by lung tissue.

The white paper details previously completed clinical studies demonstrating the safety and effectiveness of Generex Oral-lyn™, including rapidity of both absorption and onset of action, and improved metabolism of glucose when compared to injection.

As noted in the white paper, the success of clinical work-to-date, together with the positive outcome of the recent dog study, "provide support and confidence to move forward as quickly as possible with the remaining clinical and regulatory work necessary to achieve FDA approval of the enhanced Generex Oral-lyn™ formulation."

Generex Oral-lyn™ is designed to provide patients with Type-1 or Type-2 diabetes with a safe, simple, fast, and flexible alternative to mealtime injections of insulin.

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 http://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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