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Generex Biotechnology Announces Expansion of Antigen Express Cancer Trials to Include Prostate Cancer Patients

Posted on: Tuesday, 8 August 2006, 09:00 CDT

Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that that it has entered into an agreement with the Euroclinic in Athens, Greece to commence clinical trials on a novel immunotherapeutic vaccine being developed by its wholly owned subsidiary Antigen Express, Inc. The compound has been in clinical trials for more than a year at the Walter Reed Army Medical Center in patients with breast cancer and has shown good immune stimulatory activity. Because of these positive results, it was deemed appropriate to expand studies into patients with prostate cancer.

The compound being developed, AE37, is a synthetic peptide vaccine designed to stimulate a potent and specific immune response against tumors expressing the HER-2/neu oncogene. Previous clinical studies have shown that it is safe and generates a dose-dependent immunological response in inoculated patients. Because advanced cases of prostate cancer express the HER-2/neu oncogene, it was decided to begin a separate study with these patients.

A strong immune response against HER-2/neu offers the potential to kill tumor cells that have spread to parts of the body distant from the primary tumor. In addition to breast and prostate cancer, a significant percent of other cancers, including ovarian, stomach, pancreatic and lung cancers, also express the HER-2/neu target.

The clinical studies are an extension both of the current clinical trials at the Walter Reed Army Medical Center as well as a collaboration with Dr. Constantin Baxevanis at the Saint Savas Hospital in Athens, Greece. Dr. Baxevanis is an internationally recognized investigator in the field of tumor immune responses and HER-2/neu expression. He has been involved in preclinical studies of AE37 with Antigen Express scientists. The Euroclinic Athens is a private center dedicated to diagnostics and therapeutic patient support as well as surgery.

The new prostate cancer studies will involve 30 patients, looking predominantly at immunological responsiveness to a dose of the vaccine previously shown to be well tolerated in breast cancer patients. However, imaging studies to monitor disease progression will be performed at the end of the six-month course of therapy or earlier should there be indications of therapeutic benefit.

"We are excited at the prospect of beginning clinical trials in Europe," said Dr. Eric von Hofe, President of Antigen Express. "The results to date have been very encouraging and warrant expansion of our AE37 immunotherapy trials. While cytotoxic agents clearly have their place in cancer chemotherapy, it is imperative to aggressively pursue less toxic immunotherapy strategies." The same technology used to enhance immunogenicity in AE37 is being applied by Antigen Express in its development of a synthetic peptide vaccine for H5N1 avian influenza.

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 (Generex 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 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.

 Contacts: Shayne Gilliatt Generex Biotechnology Corporation Phone: (800) 391-6755 or (416) 364-2551  Andrew Hellman CEOcast, Inc. Phone: (212) 732-4300  Dolores Naney Rubenstein Public Relations Phone: (212) 843-8018 Contact via http://www.marketwire.com/mw/emailprcntct?id=0A8F4520DA9F8755  

SOURCE: Generex Biotechnology

Source: MARKET WIRE

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