2014

Generex Announces Publication of Biomarker Studies Related to the Antigen Express Novel Immunotherapeutic AE37 in Prostate Cancer Patients

WORCESTER, Mass. and TORONTO, Feb. 27, 2014 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today announced publication of studies examining potential biomarkers associated with overall survival in prostate cancer patients treated with its immunotherapeutic agent AE37. The retrospective study examined data from 29 patients immunized as part of a Phase I study. The immunotherapeutic agent AE37 is being developed by Antigen Express, Inc. (www.antigenexpress.com), a wholly-owned subsidiary of Generex, for multiple cancer indications.

The report, entitled 'Immunologic biomarkers in prostate cancer: The AE37 paradigm,' is being published in the journal Human Vaccines and Immunotherapeutics (May 2014, Volume 10, Issue 5, online publication February 19, 2014), a peer-reviewed journal. A variety of immune related markers were examined for correlation with overall survival. Of particular interest were the findings that AE37-induced immune responses appeared to be stronger in patients with low levels of HER2 expression as well as in patients with earlier stages of disease. In a separate Phase II trial of AE37 in patients with early stage breast cancer, it has been observed that patients with lower levels of HER2 expression appear to benefit most from AE37 immunization. AE37 is designed to elicit an immune response to the HER2 protein, which is expressed at varying levels in tumors of the breast, prostate, ovarian, gastro-intestinal tract, and a variety of other cancers.

The identification of viable biomarkers is of particular interest in the field of cancer immunotherapy as generation of an immune response and subsequent efficacy can be delayed significantly beyond what is observed for conventional cancer therapies. "These studies complement nicely the data from our Phase II trial of AE37 in breast cancer patients," commented Dr. Eric von Hofe, Ph.D., President of Antigen Express. "They represent an important first step toward a comprehensive search for biomarkers to aid in the development of AE37 and will likely have application to the field of cancer immunotherapy in general."

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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