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Biopharmaceuticals Oncology

 News Release - December 16, 2008

Generex Biotechnology and Pevion Biotech Announce Plans for Immunotherapeutic Vaccine Collaboration

WORCESTER, Mass., Dec. 16, 2008 -- (Healthcare Sales & Marketing Network) -- Generex Biotechnology Corporation (NasdaqCM:GNBT ) ( and Pevion Biotech Ltd. ( have signed an agreement to work together to develop next-generation vaccines and immunotherapeutic products.

The initial goal of the collaboration will be to investigate synergies in the cancer vaccine approaches of the two companies. Both companies have in-depth experience in developing immunotherapeutic vaccines for cancers. A specific focus is oncogenes over-expressed in breast, ovarian, prostate, stomach and colon cancer, as well as a variety of other malignancies. Within this collaboration, Generex wholly-owned immunotherapy subsidiary Antigen Express, Inc. combines Pevion Biotech's virosome technology with its own technology and is conducting trials in patients with breast, prostate and ovarian cancer. The combination of the two technologies will stimulate different portions of the immune system.

Pevion Biotech has developed products based upon its virosome technology to enhance the vaccine potency of various antigens. Antigen Express is developing next-generation immunotherapeutic peptides using technology to increase antigen-specific stimulation of CD4+ T helper cells. T helper cells are known to play an important role in regulating many branches of the immune system (e.g., cellular and antibody responses) and have been characterized as the 'generals' of the immune system. Virosomes are designed to interact with cells to elicit a robust immune response, as well as to deliver antigens for specific immune recognition.

``We are very pleased to be collaborating with Pevion in the development of next-generation immunotherapeutic vaccines,'' said Dr. Eric von Hofe, President of Antigen Express. ``Virosomes have clearly shown their potential now that there are two marketed products available currently.''

Rinaldo Zurbriggen, CSO of Pevion, commented: ``This is a great opportunity to collaborate with qualified and experienced partners in the cancer field to advance their antigens as a potential next-generation immunotherapeutic approach for the treatment of cancer.''

About Pevion Biotech

Pevion Biotech is a privately owned Swiss biopharmaceutical company focusing on the preclinical and clinical development of vaccines to prevent/treat infectious diseases and cancer. For its vaccine development, the company uses its virosome technology, which is already validated by two registered and marketed vaccines. The combination of this virosome technology with novel innovative antigens substantially reduces the known risk in biotechnological development and permits the targeting of diseases where so far no appropriate treatment is available. Pevion Biotech targets indications which represent major medical needs, including prophylactic or therapeutic vaccines against breast cancer, candidiasis, RSV and hepatitis C. Three virosome-based vaccine candidates are currently in clinical development.

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 or the Antigen Express website at

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.

Source: Generex Biotechnology

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