WORCESTER, Mass., July 31, 2007 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) announced today publication in the peer-reviewed International Journal of Cancer (published online Jul 16, 2007) of studies demonstrating the anti-tumor activity of its novel Ii-Key/HER-2/neu immunotherapeutic vaccine as well as mechanistic explanations for the enhancements observed using this proprietary vaccine. The studies were conducted as part of a collaboration between the Cancer Immunology and Immunotherapy Center, Saint Savas Cancer Hospital, Athens, Greece and Antigen Express, Inc., the immunotherapeutic subsidiary of Generex. The article was authored by Ioannis F. Voutsas, Angelos D. Gritzapis, Louisa G. Mahaira, Maria Salagianni, Eric von Hofe, Nikoletta L. Kallinteris, and Constantin N. Baxevanis.
The International Journal of Cancer publishes material under a broad scope of topics relevant to experimental and clinical cancer research. Its readership is comprised of cancer physicians and investigators, epidemiologists, virologists, immunologists, oncologists, and occupational and environmental health scientists.
The publication, entitled "Induction of potent CD4+ cell-mediated responses by a helper HER-2/neu peptide linked to the Ii-Key moiety of the invariant chain", presents studies showing how the proprietary portion of the immunotherapeutic vaccine enhances the potency of peptide vaccines. Specifically, the modification developed by Antigen Express increases the interaction time between the peptide vaccine and T helper cells, thereby enhancing specific stimulation against the HER-2/neu peptide. The further studies show that T helper cells stimulated by the vaccine increase the length of time tumor-infiltrating lymphocytes exhibit anti-tumor activity.
The HER-2/neu vaccine being developed by Antigen Express (AE37) is currently in Phase II clinical trials in patients with breast cancer. Those studies are being conducted in conjunction with United States Military Cancer Institute's Clinical Trials Group under a Clinical Trial Agreement. The same compound will also be investigated in patients with HER-2/neu-positive prostate cancer. Patients for those trials have been selected and dosing is expected to begin before the fall of 2007. The latter trial will be conducted as an extension of the collaboration between Antigen Express and the Saint Savas Cancer Hospital.
"Our recent studies further establish the scientific underpinnings of the Antigen Express technology in general and for the clinical development of AE37 in particular," said Dr. Eric von Hofe, President of Antigen Express. "Publication in the International Journal of Cancer demonstrates the thoroughness and scientific rigor that goes into the development of Antigen Express products."
In addition to the development of immunotherapeutic cancer vaccines, Antigen Express is also developing vaccines for infectious diseases. A Phase I trial of a peptide vaccine for use against the potentially pandemic H5N1 avian influenza virus, developed using the same technology used for AE37, was recently initiated. The particular advantage of Antigen Express vaccine technology for preparation against bird flu is that it relies on the use of synthetic peptides, which can be manufactured more rapidly and in larger amounts than traditional 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 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 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.