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SOURCE Generex Biotechnology Corporation
WORCESTER, Mass. and TORONTO, June 12, 2014 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today announced an interview given by Dr. Elizabeth Mittendorf, M.D., Ph.D. Dr. Mittendorf is the Principal Investigator of the AE37 clinical trial to test the ability of the novel immunotherapeutic agent to prevent relapse in patients who have had HER2-expressing breast cancer, the largest Phase IIb peptide clinical trial conducted to date. AE37 is being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). The interview was conducted by Oncology TV at this year's Annual Meeting of the American Society of Clinical Oncology (ASCO), held in Chicago from May 30 to June 3. The interview can be viewed online at:
Dr. Mittendorf, Associate Professor, Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, noted during the interview that the Phase II trial of AE37 in breast cancer patients had accomplished what it was intended to do: establishing that it was safe, well tolerated, and identified the patient groups that would benefit most from the AE37 vaccine in terms of preventing relapse. In particular, she noted that patients with low HER2 expression, who are not eligible for Herceptin, and especially triple negative patients, appeared to benefit the most. She further pointed out that patients were generally enthusiastic to receive the vaccine, indicating that it was given at a time when standard of care therapy was completed and there was really nothing more for patients to do but wait. The current data showed a 40% reduction of relapse in patients with low HER2 tumors and a 60% reduction in patients with triple negative breast cancer.
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.
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