Breast Cancer Vaccine Reduces Cancer Recurrence in Women: Interim Results From Phase 2 Clinical Trial Trend Toward AE37 Vaccine Benefit; Results Presented at SABCS

WORCESTER, Mass. and TORONTO, Dec. 8, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT.OB) today announced that positive interim Phase 2 clinical data from its ongoing study of a novel Ii-Key Hybrid-based HER-2/neu Peptide Vaccine (AE37) in HER-2 expressing breast cancer patients were presented at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.  The AE37 vaccine is being developed by its wholly-owned subsidiary, Antigen Express, Inc.

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"We are encouraged by the positive interim results in disease-free survival demonstrated in the randomized Phase 2 study with AE37 vaccine, especially in patients with low HER2 expression that are not currently eligible for Herceptin® (trastuzumab; Roche-Genentech)," said Dr. Eric von Hofe, Ph.D., President of Antigen Express.  "While the number of patients with recurrent breast cancer is still too low to demonstrate statistical significance in this ongoing study, we project a sufficient number of events in 2012 and expect to report final results during this period."

The results were presented at SABC by COL George E. Peoples, MD's Cancer Vaccine Development Program on December 7^th.  "Women with breast cancers expressing low levels of HER2 do not benefit from targeted HER2 therapies that are currently available," said COL Peoples, a leading researcher in adjuvant breast cancer vaccine development. "Our research is focused on reducing the recurrence of cancer using a woman's own immune system to fight her disease, including breast cancers that express low levels of HER2.  The AE37 vaccine is based on over 5 years of research and continues to show promise in a well-designed and ongoing randomized Phase 2 clinical trial that if positive, will allow rapid transition to Phase 3."

AE37 is the subject of an ongoing, controlled, randomized, and single-blinded Phase 2 clinical study in human epidermal growth factor receptor 2 (HER2) expressing patients with either node positive or high-risk node-negative breast cancer.  Patients are randomized to receive AE37 plus granulocyte-macrophage colony-stimulating factor (GM-CSF) or GM-CSF alone (control).  The primary endpoint is a reduction in cancer relapse after two years.

There are currently over 250 patients enrolled in the Phase 2 study.  Kaplan-Meier projections of updated data presented at SABCS ("An Update of a Phase II Trial of the HER2 Peptide AE37 Vaccine in Breast Cancer Patients to Prevent Recurrence," abstract #PT1-13-01) demonstrate that disease-free survival in the low HER2 expressing patients was 88.6% in the treated group (n=53) versus 71.9% in the control arm (n=78) at a median follow-up of 22 months. 

Patients treated with vaccine also exhibited a statistically significant increase in positive immune reactions to a test dose of HER2 (AE36 (HER2:776-790)) protein including maintenance of positive immune response up to 12 months post-vaccination while there have been no changes in immune responses for control patients. 

The Company is assessing the data for potential opportunity to move forward with a Phase 3 clinical development program following an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for AE37, which Antigen Express believes, if confirmed, could occur in the first half of 2012.

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 peptide fragment of the human epidermal growth factor receptor 2 (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 represents the only HER2-based peptide vaccine currently being studied in a randomized trial and its use is not restricted to patients with a particular type of human leukocyte antigen (HLA) peptide. 

About Breast Cancer
According to the American Cancer Society, more than 232,000 women will be diagnosed with breast cancer, and nearly 40,000 will die from the disease, in 2011. For women whose cancer tests positive for increased quantities of the HER2, approved targeted therapies include trastuzumab (Herceptin®; Roche-Genentech).  However, only 25% of breast cancer patients have HER2 levels high enough to be eligible for Herceptin.  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 HER2 expression.

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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