SOURCE: Generex Biotechnology

February 13, 2007 08:00 ET

Generex Biotechnology Extends Scope of U.S. Patent Protection for Vaccine Technology

Notice of Allowance Issued by USPTO for Ii-Key Hybrid Design Technology and Use

TORONTO -- (MARKET WIRE) -- February 13, 2007 -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that its wholly owned subsidiary, Antigen Express, Inc., has received a Notice of Allowance in connection with US Patent Application No. 10/197,000 entitled Hybrid Peptides Modulate the Immune Response. The specific award covers fundamental aspects of the design and use of Ii-Key antigenic epitope hybrids in treating disease.

Potentiation of the therapeutic and prophylactic potency of vaccines using Ii-Key hybrids is a core component of Antigen Express technology. Ii-Key is a small fragment of the MHC class II associated invariant chain (Ii protein) that works by increasing the ability of specific antigens to stimulate T helper cells. Antigen Express has recently initiated a Phase II clinical trial designed to test the efficacy of one of its immunotherapeutic Ii-Key hybrid vaccines (AE37) in breast cancer. It has also initiated clinical trials on a synthetic avian influenza vaccine designed using the same principal.

"The allowances awarded offer broad protection for Ii-Key hybrid technology in the US," said Dr. Eric von Hofe, President of Antigen Express. "We are pleased to have this added level of protection." The company holds six awarded U.S. patents covering the use of Ii technology for augmentation of vaccine potency.

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™ device. The Company's flagship product, oral insulin (Generex Oral-lyn™), which is available for 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 website at www.generex.com or the Antigen Express website at www.antigenexpress.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.

Contact Information

  • For more information, please contact:

    For Generex:
    Shayne Gilliatt
    of Generex
    800-391-6755
    or 416-364-2551

    Andrew Hellman
    of CEOcast, Inc.
    212-732-4300

    Michael Smith
    of Rubenstein Public Relations
    212-843-1900
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