Generex Announces Collaboration with NHTherapeutics to Utilize the RapidMist™ Buccal Delivery Technology for Leuprolide

WORCESTER, Mass. and TORONTO, May 26, 2015 /CNW/ -- Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) today announced that it has entered into a Memorandum of Understanding with NHTherapeutics, Inc. (www.nhtherapeutics.com; NHT) 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 system.

The Generex proprietary RapidMist™ drug delivery platform technology administers active pharmaceutical ingredient via aerosolized metered dose spray into the mouth for rapid absorption by the buccal mucosa.  The Company's most advanced product in development using RapidMist™ is Generex Oral-lyn™, an insulin spray product for the treatment of diabetes mellitus.

NHTherapeutics holds intellectual property in respect to the dosing regimen and route of administration of Leuprolide and other GnRH agonists for the treatment of hypogonadism and other endocrine disorders.

Pursuant to a fee-for-service arrangement, Generex will develop a RapidMist™ formulation of Leuprolide designed to achieve the safe, simple, rapid, dose-specific, and effective administration of the active pharmaceutical ingredient into the human body via the buccal mucosa.  Thereafter, Generex will undertake local irritation and stability testing of the formulation.

It is contemplated that, pending the outcome of the RapidMist™ Leuprolide formuation data, Generex will grant to NHT 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.  Conversely, NHT intends to administer low dose Leuprolide and other GnRH agonists through an easy to use buccal spray to chronically increase hormonal levels.  Proof of concept data already exists.  "NHT recognizes that the Generex RapidMist™ drug delivery platform and attendant product development experience, together with NHT's expertise in the field of endocrine disorders, creates a unique opportunity to formulate Leuprolide for rapid and effective administration through the buccal mucosa," commented Dr. David Brusegard, Ph.D., the Company's Chief Operating Officer. "Generex is pleased with this new opportunity to expand our RapidMist™ platform technology."

Dr. Aldemar Degroot, M.S., Ph.D., the President & Chief Executive Officer of NHT, stated:  "There is a real market need for a compound that can chronically increase hormonal levels, that is safe, can be easily administered, and that does not affect fertility.  Unlike existing products that increase hormonal release, NHT's lead product (NH901) is non-scheduled and will not induce supratherapeutic hormonal levels, which can result in severe adverse effects.  We look forward to working with Generex to make this product a reality.  Its extensive experience with the buccal delivery of peptide drugs along with its RapidMist™ technology combined with our own experience in endocrine disorders and our intellectual property are bound to lead to success."

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.

About NHTherapeutics

NHTherapeutics is a clinical stage pharmaceutical company that focuses on GnRH agonism to treat conditions associated with decreased hormonal levels (hypogonadism) due to aging or disease and other endocrine disorders.  Unlike existing therapy, NHT targets the disorders at the level of the brain and modulates the endogenous control of hormonal release.  This results in treatment of the entire spectrum of the disorder and in a more favorable safety profile.  NHTherapeutics de-risks drug development by reformulating existing drugs and leverages its IP position by repurposing these drugs for different indications.  Current treatment options for hypogonadism have abuse liability issues and other safety concerns, may be difficult to administer, and may result in infertility.  To that end, NHT's lead product, NH901, is being developed as a safe, easy to administer oral formulation that can be used for a range of endocrine disorders. 

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

Generex Biotechnology Corporation, Todd Falls, 800-391-6755; NHTherapeutics INC, Toronto, 416-562-7451, http://www.generex.com