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Generex Subsidiary Antigen Express to Present AE37 Cancer Vaccine Phase 2 Clinical Data at 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium
Date:11/21/2011

WORCESTER, Mass. and TORONTO, Nov. 21, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT.OB) (www.generex.com) announced today that its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), will present new Phase 2 clinical data from its study of a novel Ii-Key Hybrid-based HER-2/neu Peptide Vaccine (AE37) in HER-2 expressing breast cancer patients at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas on December 7, 2011.  

(Logo: http://photos.prnewswire.com/prnh/20110106/NY25057LOGO-b)

Antigen Express also announced the notification of a decision to grant a patent by the Japanese Patent Office relating to the Company's core Ii-Key Hybrid technology platform.

Data Presentation at SABCS

Authors:  Diane F. Hale; Sonia A. Perez; Alan K. Sears; Guy T. Clifton; Timothy J. Vreeland; Jarrod P. Holmes; Alexandros Ardavanis; Nikos Pistamaltzian; Giannis Rellias; Sathibalan Ponniah; Michael Papamichail; George E. Peoples; Elizabeth A. Mittendorf

Title:  "An Update of a Phase II Trial of the HER2 Peptide AE37 Vaccine in Breast Cancer Patients to Prevent Recurrence"

Poster Session I:  Treatment - Therapeutic Strategies: Immunotherapy (P1-13-01)

Session Date and Time:  Wednesday, December 7, 2011, 5:00 p.m. – 7:00 p.m. Central Time

Location:  Henry B. Gonzalez Convention Center, San Antonio, Texas, Exhibit Halls A-B

About AE37 and Ii-Key Hybrid Platform Technology

Antigen Express is a platform technology and product-based company developing proprietary vaccine formulations for large, unmet medical needs.  The Company's Ii-Key Hybrid technology platform entails the modification of fragments of antigens to increase their potency in stimulating critical members of the immune response, known as CD4+ T helper cells.  Incorporating the Ii-Key modification along with tumor-associated antigens can greatly enhance the immune system's ability to recognize and destroy cancer cells bearing any of the targeted antigens as well as increasing immunological memory.

The first product candidate utilizing the Company's novel Ii-Key Hybrid technology platform is a HER-2/neu Peptide Vaccine (AE37).  This "off-the-shelf" cancer immunotherapy product candidate 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.

The many clinical trials conducted in the field of active immunotherapy of cancer over the last decade have provided increasing evidence that it is possible to engage the immune system to focus on and destroy cancer cells.  Part of what has been learned over this time is the importance of specific activation of CD4+ T-helper cells in the generation of a robust and effective immune response.  Equally clear is the validity of the HER2 protein as a target for cancer therapy.  Importantly, HER2 is expressed at low to intermediate levels in a high percentage of breast as well as many other tumor types.  HER2 expression at these levels requires active immunotherapy, such as 6AE37, rather than passive immunotherapy such as Herceptin.  For this reason, the Company is continuing with plans for a Phase II prostate cancer study as well as other novel clinical applications of AE37 with interested parties.

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.


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