SOURCE: Generex Biotechnology Corporation

April 16, 2007 09:00 ET

Generex Biotechnology Vaccine Development Programs Presented at the Annual Meeting of the American Association for Cancer Research

TORONTO -- (MARKET WIRE) -- April 16, 2007 -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that presentations will be made this morning at the 2007 Annual Meeting of the American Association for Cancer Research (AACR) in Los Angeles (www.aacr.org) regarding two vaccine development programs initiated by its wholly owned Antigen Express subsidiary. One presentation will report on the immunological response in patients to its AE37 breast cancer vaccine while the second presentation puts forward preclinical data on a cell-based vaccine for patients with acute myelogenous leukemia (AML).

Antigen Express scientists have pioneered strategies for enhancing T helper cell stimulation using both peptide and cell-based immunotherapeutic vaccine methods. A robust, antigen-specific T helper cell response is crucial for generating an effective anti-tumor immune response as well as a protective response against infectious agents.

The most advanced project to be presented relates to the clinical trial of AE37, a novel peptide vaccine being tested in patients with breast cancer. That study has recently entered Phase II clinical trials under the direction of COL George Peoples, MD, Medical Corps, U.S. Army, stationed at Brooke Army Medical Center. The presentation, Comparing CD4+CD25+FoxP3+ regulatory T cell levels with ex vivo immune assays and clinical delayed type hypersensitivity responses in a novel HLS Class II HER-2/neu peptide vaccine clinical trial in breast cancer patients, to be given by Matthew Hueman from COL Peoples group, shows that a specific class of T cells known as regulatory T cells (which have been shown to inhibit the immune response) are specifically down-regulated in AE37-immunized patients and that this down-regulation is associated with an increased immunological response. This is a promising observation for the potential clinical utility of AE37.

The second presentation, The generation of the MHC class II+/Ii- phenotype in AML cells by human Ii-RNAi: A strategy to create a potent AML cell immunotherapy, will be given by Minxhen Xu, Ph.D., the Vice President of Biology at Antigen Express. Those studies demonstrate the use of RNAi to inhibit Ii expression in primary human leukemia cells. A number of prior studies, both from Antigen Express and from independent laboratories, have shown that inhibition of expression of the Ii protein in the presence of expression of MHC class II molecules (i.e., to generate the MHC class II+/Ii- phenotype) can produce a potent, immunotherapeutic cancer vaccine cell. The Company recently entered into an agreement with Daopei Hospital in Beijing to conduct Phase I clinical trials.

AACR is the authoritative source of information about advances in the causes, diagnosis, treatment and prevention of cancer. By accelerating the growth and spread of new knowledge about cancer, AACR is on the front lines of the quest for prevention and cure. AACR is the oldest and largest scientific organization in the world focused on every aspect of high-quality, innovative cancer research. Its reputation for scientific breadth and excellence attract the premier researchers in the field. The programs and services of AACR foster the exchange of knowledge and new ideas among scientists dedicated to cancer research, provide training opportunities for the next generation of cancer researchers, and increase public understanding of cancer.

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
    Generex
    800-391-6755 or 416-364-2551

    Andrew Hellman
    CEOcast, Inc.
    212-732-4300