WORCESTER, Mass., Nov. 5, 2007 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) announced today that the first prostate cancer patients had been treated with its novel peptide vaccine in a Phase I clinical trial. The trial is being conducted as an extension of a collaborative agreement between Generex's Antigen Express division and the Saint Savas Cancer Hospital. The Laikon Hospital, University of Athens will also function as a site for the trial.
In addition to safety, the Phase I study will seek to establish specific immunological responses to the AE37 vaccine peptide in 30 patients. AE37 consists of a peptide derived from the tumor associated HER-2/neu protein that has been modified to increase its ability to stimulate T helper cells. The same vaccine peptide has recently entered Phase II clinical trials in breast cancer patients, having been shown to be safe, well-tolerated and able to generate a specific immune response in a Phase I trial in breast cancer patients. Though the current study is not designed to test efficacy, imaging and Prostate Specific Antigen (PSA) levels will be monitored in patients throughout the study to assess tumor status.
Antigen Express has been collaborating with the laboratory of Dr. Costas Baxevanis of the Saint Savas Cancer Hospital for the past three years. Those studies have clearly shown the potential of AE37 both in stimulating T helper cells obtained from cancer patients as well as in pre-clinical animal tumor models.
Antigen Express is focused on developing active immunotherapy products for serious diseases and unmet medical needs. Currently the company has an immunotherapeutic peptide in Phase II clinical trials for breast cancer and in Phase I trials for the potentially pandemic H5N1 avian influenza.
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, 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 http://www.generex.com or the Antigen Express website at http://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.
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For Generex:
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American Capital Ventures, Inc.
Craig Kulman
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