Biopharmaceuticals FDA

 News Release - January 23, 2006

Generex Biotechnology Announces FDA Pre-IND Meeting Scheduled for the Avian Flu Vaccine

Antigen Express Subsidiary Preparing to File IND Application

TORONTO--(Healthcare Sales & Marketing Network)--Jan 23, 2006 -- Generex Biotechnology Corporation (NasdaqSC:GNBT ) announced today that Antigen Express, Inc., its wholly owned immunotherapeutics subsidiary, will meet with the U.S. Food and Drug Administration (FDA) on February 10, 2006 to discuss requirements for the filing of an Investigational New Drug (IND) application for the novel Antigen Express vaccine to protect against the H5N1 avian influenza and the commencement of human clinical trials.

A major drawback to current vaccine development efforts is the inability to manufacture enough vaccine in the event of an avian flu pandemic. Current estimates are that the total production capacity of the world for producing an avian flu vaccine using traditional methods is less than 40 million doses, at the cost of several hundred million dollars. A compounding problem in developing vaccines for the avian flu is that two high doses are required to achieve protective immunity given that people have never been exposed to a flu virus similar enough to impart even partial immunological protection.

The great advantage of the Antigen Express vaccine is the ability to induce a strong T-helper cell response using a synthetically manufactured peptide. This is important, as a strong T-helper response plays a major role in helping the body to develop neutralizing antibodies to viral infections. Because the Ii-Key/H5 hybrids can be manufactured synthetically, they are less expensive than cell-culture or hen-egg produced vaccines and it is possible to produce them in much larger quantities quicker in existing facilities. The induction of a good T-helper response is expected to greatly reduce the amount of classically produced vaccine necessary to achieve protective immunity. It is also expected that the Ii-Key/H5 vaccine hybrids will afford some significant degree of protection in humans who have received no other vaccine.

Scientists at Antigen Express are developing a vaccine for the potentially pandemic Asian bird flu (H5N1 strain) utilizing highly conserved fragments of the H5 protein to stimulate potent T-helper cell activity. The H5 fragments are modified using a portion of an immunoregulatory protein (termed Ii-Key) that greatly facilitates their ability to stimulate T-helper cell responses specific to the H5N1 strain. The vaccine peptides have been selected for their likelihood of being both potent and active in more than 80% of the population.

Antigen Express scientists designed and synthesized a panel of 24 Ii-Key/H5 hybrid vaccine peptides, using computer-modeling predictions to identify those with the greatest chance of being active in diverse populations. Recently completed studies demonstrated that T-helper cells from mice immunized with recombinant H5 protein or H5 DNA responded strongly in INF(gamma) and IL-4 ELISPOT assays to three Ii-Key/H5 hybrids, indicating that the natural response to H5 protein involved T-helper cell recognition to three of the H5 peptides we had designed. Subsequent experiments demonstrated that immunization of mice with the three Ii-Key/H5 hybrids alone also lead to strong T cell responses.

About Generex

Generex is engaged in the research and development 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 (Oral-lyn(TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Antigen Express 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 Web site at www.generex.com.

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 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.

Note to Editors: In the fifth paragraph, "(gamma)" is used to represent the gamma symbol, which cannot be transmitted over the wire.

Source: Generex Biotechnology

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