SOURCE: Generex Biotechnology

March 26, 2007 09:45 ET

Generex Biotechnology to Test Novel RNAi-Based Immune-Response Strategy in Cancer Patients

Clinical Trials to Be Conducted in Beijing, China With Renowned Hematologist

TORONTO -- (MARKET WIRE) -- March 26, 2007 -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that its Antigen Express subsidiary has entered into an agreement with Beijing Daopei Hospital in Beijing, China to conduct clinical trials on a novel immunotherapeutic strategy using the Company's proprietary methods of RNAi stimulation of the immune response against the patients' immune cells. The trials will be conducted under the direction of Dr. Daopei Lu. Dr. Lu was the first to perform bone marrow transplantations in China, has been involved in many clinical trials, and has authored over 200 articles in peer-review journals. RNAi (RNA interference) refers to the introduction of homologous double stranded RNA (dsRNA) to specifically target a gene's product, resulting in null or hypomorphic phenotypes. The technology is being viewed as a possible groundbreaking improvement over current therapies, such as chemotherapy for cancer, which uses a broad stroke method, destroying the cancer cells but damaging healthy cells in the process.

The strategy pioneered by Antigen Express involves modifying the patient's cancer cells to increase their immunogenicity and thereby enable the immune system to fight off the cancer anywhere in the patient's body. Antigen Express scientists and others have shown that cancer cells expressing MHC class II molecules but not the MHC class II associated invariant chain (Ii protein) can be used as robust vaccines in pre-clinical models. The Ii protein serves to block MHC class II molecules from associating with aberrant tumor-associated peptides in the cancer cell which it could otherwise present on the surface of the cell to activate T helper immune cells. Normally, the expression of MHC class II molecules and the Ii protein are strongly linked, such that if one is expressed so is the other. While some groups have used cloning methods to introduce genes for a MHC class II molecule into cancer cells without a gene for Ii (thereby creating a potent cancer cell vaccine) these methods are not practical for clinical application. Antigen Express has developed proprietary methods using RNAi to specifically inhibit expression of the Ii protein in cancer cells already expressing MHC class II molecules that are amenable to clinical use. Cancer cells from patients with acute myelogenous leukemia will be transfected with a vector expressing RNAi to silence Ii expression. After lethal irradiation, the cells are re-introduced as a subcutaneous immunization to the patient.

"We are very pleased to be working with Dr. Daopei Lu and his team," said Dr. Eric von Hofe, President of Antigen Express. "The results from our pre-clinical studies with Dr. Lu, together with our prior studies, clearly show the potential of this immunotherapy strategy."

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 or the Antigen Express website 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.

Contact Information

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

    Andrew Hellman
    CEOcast, Inc.