WORCESTER, Mass., Aug. 7, 2008 (PRIME NEWSWIRE) -- Generex Biotechnology announced today that enrollment of patients had begun for a new Phase I clinical trial employing a novel immunotherapeutic cancer vaccine being developed at Antigen Express, its wholly-owned subsidiary. The new trial will employ two immunotherapeutic vaccines designed to work in concert to activate the immune system to recognize and kill tumor cells in breast and ovarian cancer patients.
The new trial will use the Antigen Express AE37 vaccine combined with another peptide vaccine to establish both safety and immunological response. Currently the AE37 vaccine is the subject of a Phase II clinical trial in patients with breast cancer and a Phase I trial in prostate cancer patients. Both vaccines are derived from the tumor-related HER-2/neu protein. A high percentage of breast and ovarian cancers express the HER-2/neu protein.
Antigen Express has pioneered the development of novel immunotherapeutic vaccines using proprietary technology to increase the antigen-specific stimulation of CD4+ T helper cells. Both pre-clinical and clinical studies have shown the importance of activation of this cell type for successful cancer immunotherapy.
The trial is being conducted as part of a collaboration between Antigen Express, Dr. George Peoples at the Brooke Army Medical Center and the Mary Crowley Cancer Center, which is funding the trial.
About Generex Biotechnology Corporation
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(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 which was approved for sale in India in October 2007, is in Phase 3 clinical trials at several sites around the world. For more information, visit the Generex website at http://www.generex.com.
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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 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.