Generex Announces Publication of Follow-up Studies from Phase I Trial of Novel Immunotherapeutic in Prostate Cancer Patients

WORCESTER, Mass. and TORONTO, Aug. 20, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today announced publication of follow up studies from a Phase I clinical trial of its immunotherapeutic agent AE37 in patients with prostate cancer. The Phase I study demonstrated that the compound is safe, well-tolerated, and generated a specific and robust immune response. AE37 is being developed by the Company's wholly-owned subsidiary, Antigen Express Inc. (www.antigenexpress.com).

The report, entitled 'AE37 peptide vaccination in prostate cancer: a 4-year immunological assessment update on a phase I trial' is being published in the journal Cancer Immunology, Immunotherapy (August 2013).  The journal focuses on new concepts and advances in basic, translational, and clinical cancer immunology and immunotherapy.  Both the immunological and disease status of patients was assessed as part of the follow up.  Even three years after the last dose of AE37 was administered, elevated levels of specific immunity could be detected, demonstrating that the vaccine had indeed induced long-term immunological memory.

Intriguingly, none of the patients in this study belonging to the intermediate or high risk groups as determined by Gleason score developed metastasis, even though metastases would have been predicted to occur in roughly 27% of nine intermediate-risk patients and 60% of eight high-risk patients based upon historical data from patients with these stages of disease.  In addition, the median overall survival of six patients with metastatic disease was 89 months, which considerably exceeds that usually observed in this group historically.

"While clearly not designed as an efficacy study, the lack of disease progression observed in this Phase I trial is encouraging," commented Dr. Eric von Hofe, Ph.D., President of Antigen Express.  "The longevity of the immunological response speaks to the robust yet specific mechanism of action of AE37 and the technology platform upon which it was designed," he added.

AE37 is also the subject of a controlled, randomized and single-blinded Phase II trial to prevent relapse in patients who have had breast cancer.  An interim analysis showed a strong trend toward reduction in relapse in patients receiving the vaccine, particularly those with low to intermediate levels of the HER2 protein.  Patients in this category have few treatment options.  Primary efficacy results from the study are expected to be released this fall.  The FDA previously has encouraged the company to submit a Phase III protocol based upon the interim analysis.

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