Generex Announces ASCO Presentations of AE37 Vaccine Data; Potential Leading Immunotherapy Option for Breast Cancer Patients

WORCESTER, Mass. and TORONTO, June 5, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) today announced two presentations showing the strengths of AE37 as a viable and promising treatment option for patients who have had breast cancer.  The compound is being developed by its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com).  The two presentations were made at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago from May 31 to June 4.

The two presentations focused on the safety and long-term immunity that can be achieved with AE37 treatment.  The first presentation, "Risk factors for development of delayed urticarial reactions in the phase II trial of HER2 peptide vaccines plus GM-CSF versus GM-CSF alone in high-risk breast cancer patients to prevent recurrence", by Alfred Trappey et al, reports on cumulative safety data from the ongoing Phase II efficacy study.  The maximum toxicities observed (allergic reactions) occur very infrequently, are easily managed, and have no long-term consequences.  In addition, they were observed both in the control arm of the study as well as in the peptide arm, indicating that they were associated with the GM-CSF adjuvant rather than the peptide.  The demonstrated safety of AE37 in this larger Phase II patient population confirms prior observations from earlier previous Phase I studies.

"I am very pleased with the progress Antigen Express has made over the years, particularly with the AE37 vaccine program," stated Richard Purcell, Chief Operating Officer of Antigen Express.  "The AE37 data continues to track positively, as shown by the immunological and safety results presented in Chicago this week.  Given the buzz, excitement, and significant focus on immunotherapy at ASCO this year, a big pharma partnership is a realistic expectation for the Company in the near future."

The second presentation extended results from a published 2013 ASCO abstract, ("Effect of immunization with Ii-Key modified HER2 (776-790) peptide vaccine (AE37) on immunologic responses in prostate cancer patients", by Sonia Perez et al) showing that AE37 induced immunological responses for longer time periods than have been observed with any other peptide vaccines used for breast cancer.  In particular, the recent presentation "Booster inoculations of the AE37 peptide vaccine enhance immunological responses in a phase II study", by Eleftheria Anastasopoulou et al, showed that administration of AE37 as a booster for up to two years after the initial therapy further increased the level of specific anti-tumor immunity that could be observed in patients.  Not only can the specific immune response be maintained but is even augmented by subsequent dosing.

The strong safety profile and superior immunogenicity set AE37 apart, both from other types of immunotherapy as well as other peptide immunotherapies targeting breast cancer.  Combined with highly encouraging interim results, showing a reduction of relapse in patients treated with AE37 in a controlled, randomized Phase II efficacy trial, these latest studies support ongoing plans the Company has for a pivotal Phase III registration trial.

"Several distinct products are being developed with the Antigen Express Ii-Key technology and are at various stages of development," said Joe Moscato of Company consultant Seahawk Capital Partners, Inc. "Our attendance at ASCO 2013 gave Antigen Express the opportunity to initiate and continue discussions with multiple interested prospective big pharma partners and collaborators.  The different products have applicability in diseases such as breast cancer, prostate cancer, ovarian cancer, influenza, and HIV.  Interim data from October of 2011 suggested efficacy in our AE37 breast cancer vaccine, enhanced with our proprietary Ii-Key/HER2 antigen hybrid, has helped to validate Antigen Express' Ii-Key technology overall."  Mr. Moscato went on to say:  "The Ii-Key hybrid technology allows tumor-associated or foreign antigens, like viral antigens, to potently enhance the immune system's ability to recognize and destroy cancerous or virus-infected cells bearing any of the targeted antigens, as well as generate immunological memory.  We are committed to finding alliances and partners to work together on the best clinical trial programs for each distinct product and, as the end of this year approaches, and new data is unveiled in our late-stage Phase IIb breast cancer trial, we are looking to have sufficient positive data to attract and finalize key partnerships and collaborations."

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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