Generex Announces Agreement With the Immune Tolerance Network


WORCESTER, Mass., April 21, 2009 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com) announced today that Antigen Express, Inc., the Company's wholly-owned immunotherapeutics subsidiary, and the Immune Tolerance Network (www.immunetolerance.org) have signed an agreement aimed at implementing a better diagnostic test for Type-I Diabetes. The diagnostic test is based on technology being developed by Antigen Express. The ability to identify patients with autoimmune or Type-I Diabetes earlier and more accurately would greatly benefit the management of such patients.

The proprietary technology being developed at Antigen Express allows for more potent and specific activation of immune cells (CD4+ T helper cells), both after immunization and using blood cells ex vivo. In Type-I Diabetes, these cells become aberrantly activated to recognize proteins associated with cells involved in insulin secretion, which ultimately leads to the destruction of these cells. Antigen Express technology allows for the more sensitive detection of these inappropriately activated cells in the blood.

The Immune Tolerance Network is a non-profit, government-funded consortium led by the world's foremost authorities in the field of immune tolerance. The group is focused on establishing new treatments for autoimmune diseases (e.g. Type I-Diabetes, Multiple Sclerosis, and others), organ transplant rejection, and on the prevention and treatment of allergies and asthma.

Antigen Express is also developing an immunotherapeutic vaccine for breast, prostate and other cancers. The technology utilized in the design of that immunotherapeutic is the same as that used for the ex vivo detection of inappropriately activated CD4+ T helper cells in patients with Type-I Diabetes. To date, the anti-cancer immunotherapeutic being developed, AE37, has been shown to be safe, well tolerated and produces the desired specific immune response in cancer patients. Currently, AE37 is the subject of a Phase II efficacy study in patients with breast cancer, a Phase I study in patients with prostate cancer and, in combination with another peptide vaccine, a Phase I trial in patients with either breast or ovarian cancer. A synthetic peptide vaccine for H5N1 avian influenza, based on the same technology, is also the subject of a Phase I trial in healthy volunteers.

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(tm) device. The Company's flagship product, oral insulin (Generex Oral-lyn(tm)), which is available for sale in India and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

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Safe Harbor Statement

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," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects," 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 cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. 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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