SOURCE: Generex Biotechnology

July 10, 2006 07:30 ET

Therapeutic Efficacy of Generex Biotechnology Anti-Tumor Vaccine Demonstrated in Preclinical Animal Model

TORONTO -- (MARKET WIRE) -- July 10, 2006 -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that Dr. Eric von Hofe, President of Antigen Express, Inc., the Company's wholly owned immunotherapeutics subsidiary, presented additional pre-clinical studies conducted with their immunotherapeutic peptide vaccine currently in Phase I clinical trials in patients with breast cancer. The studies were presented at the Vaccine Technology scientific symposium held in Puerto Vallarta, Mexico, June 27 - 30, 2006.

The preclinical studies were conducted in collaboration with Dr. Constantin Baxevanis at the Saint Savas Cancer Hospital in Athens, Greece. The results were presented in conjunction with interim results from ongoing Phase I clinical trials being conducted at the Walter Reed Army Medical Center in patients with breast cancer.

Antigen Express is developing a novel immunotherapeutic peptide vaccine for use in patients with tumors expressing the HER-2/neu oncogene. Roughly 75% of patients with breast cancer show some level of HER-2/neu expression in their tumors. While only 25% of breast cancers have levels of HER-2/neu expression high enough to be candidates for treatment with Herceptin® (a humanized monoclonal antibody directed at HER-2/neu), those cancers expressing lower levels are expected to be good candidates for active immunotherapy as is being pursued at Antigen Express. A significant percent of other types of cancer, including prostate and lung cancers, also express HER-2/neu.

The recent studies clearly showed that CD4+ T helper cells stimulated with the Antigen Express vaccine potentiated the activity of tumor-specific cytotoxic T cells to the point that cures were observed in 40% of mice and significantly slower tumor growth was observed in the remaining mice. Together with the findings of good CD4+ T helper stimulation in patients receiving the vaccine in the clinic, these studies point to the therapeutic potential of the vaccine.

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 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 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

  • Contact:
    Shayne Gilliatt
    Generex Biotechnology Corporation
    Phone: (800) 391-6755
    (416) 364-2551

    Andrew Hellman
    CEOcast, Inc.
    Phone: (212) 732-4300