Generex Biotechnology to Collaborate With Leading Investigator At the Univerity of Rochester On Pandemic Avian Influenza Vaccine
WORCESTER, Mass., Aug. 22, 2007 -- Generex Biotechnology Corporation announced today that its wholly-owned immunotherapy subsidiary, Antigen Express, Inc., has entered into an agreement with the University of Rochester as part of the Antigen Express efforts to develop a novel vaccine against the potentially pandemic avian influenza. The collaboration brings together Dr. John Treanor, an internationally recognized leader in the clinical development of pandemic influenza vaccines, and the novel peptide vaccine technology pioneered by Antigen Express. Dr. Treanor is Professor of Medicine, and of Microbiology and Immunology, in the Department of Medicine at the University of Rochester Medical Center.
Antigen Express is involved in the clinical development of peptides designed to potently stimulate CD4+ T helper cells through enhanced interaction with MHC class II molecules. Earlier this year, the Company began Phase I clinical studies of proprietary peptides derived from the hemagglutinin protein of the H5N1 avian influenza virus in healthy volunteers. The particular value of using modified peptide vaccines for avian influenza is that they can be manufactured by an entirely synthetic process which reduces cost and increases both the speed and quantity of production relative to the traditional egg-based or cell-culture based vaccines. An additional value is that the peptides are derived from regions of the virus that are similar enough in all H5N1 virus strains such that they would not have to be newly designed for the specific strain to emerge in a pandemic.
In addition to a vaccine for avian influenza, the Company is also conducting clinical trials of another peptide to stimulate an immune response to a tumor-associated protein in breast cancer patients. That peptide was designed by similar proprietary means to those being used for avian influenza. A Phase II breast cancer vaccine trial was initiated the first part of this year based on a successful Phase I trial wherein the modified peptide was found to be safe, well-tolerated, and stimulated the desired antigen-specific response as measured in the peripheral blood cells of breast cancer patients.
"We are very pleased to be working with Dr. John Treanor and are looking forward to a productive relationship," said Dr. Eric von Hofe, President of Antigen Express. "He is an outstanding immunologist with extensive experience in the clinical development of avian influenza vaccines."
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 is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes and before the end of 2007 the Company expects to begin Phase 3 trials of the product in the United States, Canada and Europe. 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.