Generex Biotechnology granted United States patent in connection with its RapidMist(TM) device

New patent expands protection for RapidMist

January 5, 2006 — /MARKET WIRE/ — TORONTO — Generex Biotechnology Corporation (NASDAQ: GNBT), a leader in the area of buccal drug delivery, announced today that it has been granted another United States patent. The patent entitled, “Cleaning Compounds for and Method of Cleaning Valves and Actuators of Metered Dose Dispensers Containing Pharmaceutical Compositions,” relates to the formulation and methodology for cleaning the Company’s proprietary RapidMist device which is designed to deliver pharmaceutical products, including Oral-lyn(tm), the Company’s proprietary oral insulin product, into the buccal cavity (the mouth) where it is absorbed into the bloodstream.

The patent covers a method of cleaning the RapidMist metered dose spray device, and a cleaning composition for such cleaning, to prevent the device from becoming clogged with medication. The cleaning composition is non-toxic and will not harm the user of the device following cleaning. This process makes the RapidMist device suitable for long-term, chronic use and ensures the accuracy and efficacy of the metered medication doses.

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

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.

Shayne Gilliatt
Generex Biotechnology Corporation

Ed Lewis
CEOcast, Inc.

SOURCE: Generex Biotechnology


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