6/8/2006 GENEREX BIOTECHNOLOGY ANNOUNCES PRESENTATION OF INTERIM BREAST CANCER TRIALS RESULTS AND BIRD FLU VACCINE STRATEGY
Synthetic peptide vaccine strategy shows activity in the clinic
June 8, 2006 – Generex Biotechnology Corporation (Nasdaq:GNBT) announced today that Dr. Eric von Hofe, Ph.D., President of Antigen Express, Inc., its wholly owned subsidiary, made a presentation of the Company’s overall peptide vaccine technology and the status of its pandemic avian influenza virus vaccine program at an international conference in San Diego. At a separate meeting in Atlanta, representatives from the Walter Reed Army Medical Center, working with Dr. George Peoples, presented results from ongoing breast cancer trials being conducted with another Antigen Express peptide vaccine.
Dr. von Hofe presented on the company’s strategy for designing synthetic peptide vaccines for antigen-specific stimulation of T helper cells in general and the potential of this strategy specifically to amplify an antibody response to avian influenza. The meeting, Antibodies and Beyond Antibodies, was held June 1-2 in San Diego and is the industry's only event that discusses antibody alternatives and next generation and optimization of antibodies. The meeting brought together an international audience of leading companies from the U.S., Australia, Europe, and the Asia Pacific to discuss scientific advances and business opportunities in this field, and to compare the opportunities and challenges of novel antibody-based techniques and next generation scaffolds for protein therapeutics. Studies from Antigen Express demonstrated that inoculation of mice with the Antigen Express proprietary vaccine peptides derived from the H5 protein of the H5N1 virus resulted in a more robust production of antibodies after subsequent challenge with the H5 protein itself.
Vaccination is the principal measure for preventing influenza and reducing the impact of epidemics. All current inactivated influenza vaccines contain trace levels of egg protein and production is time-consuming and costly. The Antigen Express proprietary vaccine is synthetic, not egg-based, and large quantities could be produced quickly and at considerably lower cost. The Company is committed to the aggressive pursuit of its avian influenza vaccine program to address the threat of an avian influenza pandemic. The Company expects that its proprietary platform vaccine technology will be readily adaptable for other influenza A viruses.
Subsequently, at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO) held June 2-6 in Atlanta, the premier educational and scientific event in the oncology community, interim results from a Phase I clinical trial of another Antigen Express proprietary peptide derived from the cancer associated HER-2/neu protein being tested in breast cancer patients was presented by Dr. Elizabeth Mittendorf, a colleague of Dr. George Peoples. Those studies, being conducted at the Water Reed Army Medical Center, demonstrated that the peptide was safe and well-tolerated. Further, a dose-dependent increase in immunological response to the peptide was demonstrated by two separate measurements of antigen-specific recognition by T helper cells.
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.
Shayne Gilliatt of Generex Biotechnology Corporation, 1-800-391-6755, or
+1-416-364-2551; or Ken Sgro of CEOcast, Inc., 212-732-4300,
kensgro@ceocast.com, for Generex Biotechnology Corporation
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