10/3/2006 GENEREX BIOTECHNOLOGY PUBLISHES STUDIES DEMONSTRATING ANTI-TUMOR POTENTIAL OF IMMUNOTHERAPEUTIC VACCINE
Toronto, Canada – October 3, 2006 – Generex Biotechnology Corporation (Nasdaq: GNBT) announced today publication of studies demonstrating specific anti-tumor activity of its novel Ii-Key/HER-2/neu immunotherapeutic vaccine. The studies were performed in the laboratory of Dr. Costas Baxevanis in collaboration with scientists at Antigen Express, the immunotherapeutic division of Generex Biotechnology.
The results of the recent efforts appear in the journal Cancer Immunology and Immunotherapy under the title “Ii-Key/HER-2/neu(776–790) hybrid peptides induce more effective immunological responses over the native peptide in lymphocyte cultures from patients with HER-2/neu+ tumors”. In addition to demonstrating increased activity in human lymphyocyte cultures of peptides designed with the proprietary Ii-Key modification, the studies also demonstrate the antitumor efficacy of these activated lymphocytes in suppressing the growth of human ovarian cancer cells (expressing HER-2/neu) in an animal model. Further, mechanistic studies demonstrated that the specifically stimulated lymphocytes worked by enhancing the activity of cytotoxic T lymphocytes (CTLs), which is consistent with the proposed mechanism of action of lymphocytes stimulated by Ii-Key/Her-2/neu hybrid peptides.
“The studies complement nicely the ongoing clinical trials of the Ii-Key/HER-2/neu hybrid peptide AE37 in breast cancer patients,” said Eric von Hofe, President of Antigen Express. “We have seen activation of lymphocytes from AE37 immunized patients similar to the activation of lymphocytes observed in the recently published studies. Taken together, these observations provide real encouragement as to the clinical utility of Ii-Key hybrids such as AE37”.
In addition to developing an immunotherapeutic vaccine for HER-2/neu expressing cancers, Antigen Express is also developing vaccines for other types of cancer and infectious diseases, including the potentially pandemic H5N1 influenza virus. The fact that Antigen Express vaccines are manufactured by an entirely synthetic process, enabling rapid production of large amounts, makes them uniquely suited for an H5N1 vaccine given the likely demand for such a vaccine and the supply limitations of more 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(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. For more information, visit the Generex Web site at www.generex.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.
Contacts:
Shayne Gilliatt
Generex Biotechnology Corporation
Phone: (800) 391-6755
or (416) 364-2551
Andrew Hellman
CEOcast, Inc.
Phone: (212) 732-4300
Dolores Naney
Rubenstein Public Relations
Phone: (212) 843-8018
Email Contact
Shayne Gilliatt of Generex Biotechnology Corporation, 1-800-391-6755, or
+1-416-364-2551; or Ken Sgro of CEOcast, Inc., 212-732-4300,
kensgro@ceocast.com, for Generex Biotechnology Corporation
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