Antigen Express Cancer Vaccine Highlighted in Expert Opinion on Biological Therapy

WORCESTER, Mass. and TORONTO, Sept. 19, 2011 /PRNewswire/ -- Generex Biotechnology Corporation's (OTCBB: GNBT) (www.generex.com) wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), today announced that AE37, a novel HER-2/neu-targeted vaccine for the treatment of breast, prostate, and other cancers, is reviewed in the September 2011 issue of Expert Opinion on Biological Therapy, a peer-reviewed, international journal publishing review articles and original papers on all aspects of biological therapy, providing expert opinion on the scope for future development.

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In the article titled "AE37: a novel T-cell-eliciting vaccine for breast cancer," senior author Col. George E. Peoples, M.D., F.A.C.S., Brooke Army Medical Center, focuses on the concept that AE37 vaccine's Ii-Key hybrid technology "has improved the potency of the AE37 vaccine to the point where it is capable of inducing immune responses even without immunoadjuvant," and that "preclinical and early clinical trials of the AE37 show potential promise for this CD4+ T-cell-eliciting vaccine in the adjuvant treatment of breast cancer."  

The article contrasts the unique ability of AE37 to stimulate CD4+ helper T cells with other therapeutic peptide vaccines that primarily stimulate CD8+ T cells, including E75 and GP2.  Another difference is that AE37 can be used to treat twice the patient population than either E75 or GP2. The article further outlines many of the trials conducted to date with AE37, including Phase I clinical trials in both breast and prostate cancer and the ongoing controlled, randomized, and single-blinded Phase II trial in breast cancer. While preliminary, the authors noted an approximate 40% reduction in the rate of breast cancer recurrence at 17 months of median follow-up in patients treated with the AE37 peptide vaccine in the ongoing trial. The authors concluded that the AE37 vaccine is safe and well-tolerated with the ability to generate sustained, robust in vitro and in vivo immune response in vaccinated breast and prostate cancer patients.

"We are pleased to see that as the data from clinical trials accumulate, AE37 continues to show that it is not only on track to achieve a positive endpoint in the treatment of breast cancer, but also shows clear advantages over other peptide and cancer vaccine strategies," said Eric von Hofe, Ph.D., President of Antigen Express.  "The clinical path forward for AE37 is straightforward, with the Phase III trial designed and ready to be implemented."

Per trial design in the ongoing Phase II study, patients are being followed for clinical recurrences; data regarding the efficacy of the AE37 vaccine will be reported after a median follow-up of 24 months. Antigen Express anticipates being able to hold an end of Phase II meeting with the FDA in the second half of 2012, followed by initiation of a pivotal Phase III trial. The company is currently seeking a partner for Phase III development and commercialization.

About AE37

Antigen Express' novel Ii-Key Hybrid Preventive HER-2/neu Peptide Vaccine (AE37) is an "off-the-shelf" cancer immunotherapy product candidate that is easier and less costly to produce than comparable cell-based approaches.  AE37 is derived from a fragment of the HER2 oncoprotein, which is expressed in a variety of tumors including 75-80% of breast cancers as well as a high percentage of prostate, ovarian and other cancers. AE37 is positioned initially as an adjuvant therapy for at least 50% of breast cancer patients; i.e., those with low-to-intermediate levels of HER-2 expression who are not eligible for treatment with trastuzumab (Herceptin®).  Only 25% of breast cancer patients have HER-2 levels high enough to be eligible for Herceptin.

A controlled, randomized, and single-blinded Phase II clinical study of AE37 in HER-2 expressing breast cancer patients is currently underway to establish clinical efficacy.  The study endpoint is a reduction in cancer relapse after two years compared to patients not receiving AE37.  There are currently over 200 patients enrolled in the study with either node positive or high-risk node-negative breast cancer.  While positive preliminary results suggested that statistically definitive results could be obtained in 2012, the company opted to enroll an additional 100 patients in early 2011 to ensure sufficient patient numbers.  In particular, these additional patients are required to have low HER-2 expression levels such that they are not eligible for trastuzumab.  It is anticipated that a planned Phase 3 trial will be conducted in this specific patient population.

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 in immunotherapy.  One of its platform technologies 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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