Generex Announces Commencement of Buccal Leuprolide R&D Work

Collaboration with NHTherapeutics has begun

WORCESTER, Mass. and TORONTO, Sept. 8, 2015 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) today announced that research and development work on buccal Leuprolide has begun.  The Company previously announced a Memorandum of Understanding with NHTherapeutics, Inc. (www.nhtherapeutics.com) pursuant to which the companies will co-develop a formulation for the delivery of Leuprolide into the human body via the buccal mucosa using the Generex proprietary RapidMist™ buccal drug delivery platform technologies.

Generex has received from NHTherapeutics the first tranche of funding under the Memorandum of Understanding as well as the initial shipment of Leuprolide.  The Generex RapidMist™ R&D protocols have been initiated, the goal of which is to achieve a formulation for the safe, simple, rapid, dose-specific, and effective administration of the active pharmaceutical ingredient into the human body via the buccal mucosa, after which local irritation and stability testing will be undertaken.

The companies' intention is that, upon successful completion of the R&D work, Generex will grant to NHTherapeutics a license for the global commercial exploitation of the product in the field of endocrine disorders in exchange for royalties.

Leuprolide belongs to a class of medications called gonadotropin-releasing hormone (GnRH) agonists.  Traditionally, GnRH agonists are used at a high dose to chronically decrease hormonal release.  Leuprolide is given by injection and is marketed to treat the symptoms associated with advanced prostate cancer, central precocious puberty (CPP), endometriosis, and anemia.  NHTherapeutics intends to administer low dose Leuprolide and other GnRH agonists through an easy to use buccal spray to chronically increase hormonal levels.

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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