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Generex Biotechnology Expands Mayo Clinic Collaboration for Vaccine Studies; Preparations Underway for Clinical Trials in Melanoma Patients

Posted on: Thursday, 26 June 2008, 09:02 CDT

WORCESTER, Mass., June 26, 2008 (PRIME NEWSWIRE) -- Antigen Express, Inc. (www.antigenexpress.com), the wholly-owned immunotherapeutics subsidiary of Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), has signed a second collaboration agreement with the Mayo Clinic (www.mayoclinic.com). Antigen Express previously entered into an agreement with the Mayo Clinic to work with Dr. Keith Knutson, a leader in the field of peptide vaccines in breast cancer. The current agreement focuses on advancing an immunotherapeutic vaccine for melanoma into the clinic with Dr. Svetomir Markovic, a distinguished translational researcher with expertise in melanoma trials.

Antigen Express has previously identified a novel peptide vaccine for melanoma and published its findings in an article titled, "Enhanced CD4+ T-Cell Response in DR4-Transgenic Mice to a Hybrid Peptide Linking the Ii-Key Segment of the Invariant Chain to the Melanoma gp100(48-58) MHC Class II Epitope," in the Journal of Immunotherapy, volume 28, pages 352-358, 2005.

"We are excited to begin the process of moving this into the clinic with Dr. Markovic," said Dr. Eric von Hofe, President of Antigen Express. "He is an outstanding investigator with whom we are fortunate to have the opportunity to work."

The immunotherapeutic melanoma vaccine was constructed using the same technology as was employed for AE37, Antigen Express's most advanced peptide vaccine currently in Phase II clinical trials in patients with breast cancer. The strategy is based on modifying fragments of a cancer-associated protein using proprietary methods to increase the antigen-specific stimulation of CD4+ T helper cells. The stimulation of T helper cells has been shown to be critical in achieving tumor immunity.

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 Ecuador for the treatment of patients with Type-1 and Type-2 diabetes and which was approved for sale in India in October 2007, is in Phase 3 clinical trials at several sites around the world. For more information, visit the Generex website at www.generex.com.

The Generex Biotechnology Corp. logo is available at http://www.primenewswire.com/newsroom/prs/?pkgid=3831

Safe Harbor Statement

This release and oral statements made from time to time by Generex representatives concerning 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.

This news release was distributed by PrimeNewswire, www.primenewswire.com

CONTACT: CEOcast, Inc. Gary Nash 212-732-4300 For Generex: American Capital Ventures, Inc. Howard Gostfrand 305-918-7000

Source: PrimeNewswire

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