|By PR Newswire||
|January 9, 2014 09:30 AM EST||
WORCESTER, Mass. and TORONTO, Jan. 9, 2014 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today announced that Dr. Eric von Hofe, PhD, President of the Company's wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), will be a keynote speaker at IBC's 16th Annual TIDES Conference (www.IBCLifeSciences.com/Tides) to be held in Providence, RI from May 12-15, 2014. TIDES, Oligonucleotide and Peptide® Therapeutics from Research through Commercialization, is the premier meeting focused on the discovery and development of synthetic biologicals.
The keynote presentation, entitled "Peptide-Based Vaccines in the New Era of Cancer Immunotherapy", will focus on changes in the field of cancer immunotherapy and specific advances enabled by Antigen Express technology and strategy. In particular, the Company has been at the forefront of demonstrating the importance of activating specific immune cells (CD4+ T helper cells) in generating an effective immune response. Encouraging interim results from an ongoing Phase II study of the Company's lead compound in breast cancer patients has given strong support for that strategy.
The Company's lead compound, AE37, designed using Antigen Express technology, targets the HER2 protein that is specifically expressed on cancers of the breast as well as other cancers. HER2 has been shown to contribute directly to cancer cell growth. While the highly successful drug Herceptin (a monoclonal antibody) also targets HER2, it is only approved for use in roughly 25% of patients whose tumors express the highest levels of HER2. An additional 50% of patients have tumors that express low to intermediate levels of HER2 are not eligible for Herceptin. It is this population of breast cancer patients with unmet need that AE37 is particularly relevant to.
"AE37 is at the forefront of a new generation of off-the-shelf cancer vaccines that Antigen Express believes hold significant promise in the emerging field of cancer vaccines," said Dr. von Hofe. "The results from clinical trials we've seen so far certainly warrant further studies both in breast cancer patients as well as in other populations of cancer patients." The FDA has encouraged submission of a Phase III protocol based on results of an interim analysis of the Phase II AE37 study conducted in patients with breast cancer.
Dr. von Hofe and other representatives of Generex and Antigen Express will be attending meetings next week in San Francisco associated with the 32nd Annual J.P. Morgan Healthcare Conference to update prospective collaborators on the companies' initiatives.
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™ device. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation technologies in immunotherapy. One focuses on modification of peptides with Ii-Key to increase potency, while a second relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
Cautionary Note Regarding Forward-Looking Statements
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," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" 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 or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. 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 Corporation
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