Generex Publishes Results From Pre-Clinical Studies On Immunotherapeutic Vaccine For HPV-Induced Cervical Cancer
Worcester, MA (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com) announced today publication of studies demonstrating the anti-cancer activity of a novel Ii-Key/HPV immunotherapeutic vaccine. The immunotherapeutic vaccine for HPV-induced cancers makes use of the Ii-Key platform technology developed by scientists at Antigen Express, Inc. (www.antigenexpress.com), Generex's wholly-owned immunotherapeutics subsidiary.
The results of the recent efforts appear in the journal Vaccine (Volume 27, Issue 34, July 2009) under the title "Ii-Key/HPV16 E7 hybrid peptide immunotherapy for HPV16+ cancers." Vaccine is the pre-eminent journal for those interested in vaccines and vaccination. It serves as an interface between academics, those in research and development, and workers in the field. Relevant topics range from basic research through to applications, safety and legislation.
The Antigen Express studies demonstrate that mice immunized with an Ii-Key/HPV16 E7 hybrid show increased killing of cells expressing an HPV-specific antigen, but not control cells lacking the antigen. Consistent with the predicted mechanism of action of the vaccine, HPV-specific activation of CD4+ T helper cells was observed in immunized mice. The first author of the study, Dr. Minzhen Xu, is Vice-President of Biology at Antigen Express.
The current studies demonstrate an additional application of the Ii-Key technology platform being developed at Antigen Express. Currently, another peptide designed with this technology is the subject of three clinical trials: a Phase II trial in breast cancer patients, a Phase I trial in prostate cancer patients, and a separate Phase I trial in breast or ovarian cancer patients wherein it is being tested in combination with another peptide vaccine. That immunotherapeutic vaccine, AE37, couples Ii-Key with a fragment of the HER2 protein, which is expressed in a variety of cancers and is associated with worse prognosis.
While prophylactic vaccines against HPV-induced cervical cancer are available, those vaccines do not benefit patients once cancer has arisen. The difference is that Ii-Key/HPV hybrid vaccines help to induce a cellular immune response, which is necessary for killing cancer cells.
In addition to developing immunotherapeutic vaccines for cancer, Antigen Express is also developing vaccines for infectious diseases, including the potentially pandemic H5N1 virus as well as the recent H1N1 pandemic virus. The fact that Antigen Express vaccines are manufactured by an entirely synthetic process, enabling rapid production of large amounts, makes them uniquely suited as a vaccine for pandemic or potentially pandemic viruses, given the supply limitations of more traditional vaccines. About Generex Biotechnology Corporation
About Generex
Generex is engaged in the research, development and commercialization 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 India and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. 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.
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This release and oral statements made from time to time by Generex representatives in respect of 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 undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. 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.
SOURCE: Generex Biotechnology Corp.
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