Generex Announces Presentation of Data Correlating Immune Response with Reduction of Relapse in AE37 Phase II Breast Cancer Trial at AACR 2015

WORCESTER, Mass. and TORONTO, April 21, 2015 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) announced today presentation of data from the on-going Phase II clinical trial of the AE37 breast cancer vaccine correlating local immune response to a reduction in relapse. AE37 is being developed by Antigen Express, Inc. (www.antigenexpress.com), a wholly-owned subsidiary of Generex. The presentation was made at the American Association for Cancer Research (AACR) Annual Meeting held in Philadelphia, PA from April 18 to 22.

The abstract entitled 'Correlation of robust local reactions prompting GM-CSF dose reduction to clinical response in a Phase II trial of the AE37+GM-CSF HER2 peptide vaccine' by Julia Greene, et al was presented at the Clinical Trials in Progress session of the AACR on April 20. The goal of the study was to establish the importance of the local reaction to immunization with AE37. The controlled, randomized and single-blinded trial is comparing the ability of AE37 plus the adjuvant GM-CSF versus the GM-CSF adjuvant alone to reduce recurrence of breast cancer in early stage patients. The study found that those patients receiving AE37 who had the largest responses (requiring reductions in the amount of GM-CSF) had a relapse rate of 5.9% versus a rate of 14.2% in those who did not require dose reduction. This indicates that a robust stimulation of the immune system by AE37, as evidenced by the need for dose reduction, results in positive anti-cancer activity.

The AE37 vaccine is designed to activate critical components of the immune system to combat cancer cells. Prior analyses have shown a trend toward reduction of relapse in patients receiving the vaccine, particularly those who are not eligible for the cancer drug Herceptin as well as those with triple negative breast cancer. The current study correlates the extent of immune response with reduction in relapse. A priority in all forms of cancer immunotherapy today is in establishing means of identifying which patients are more likely to respond to treatment.

The current results add to prior studies both from the ongoing Phase II trial as well as a completed Phase I study of AE37 in patients with prostate cancer showing robust yet specific immunological responses together with almost negligible toxicity. The distinguishing feature of AE37 is its ability to specifically activate CD4⁺ T helper cells, which govern both the quality and magnitude of an immune response to a novel target. The correlation of a robust immune response with reduced relapse confirms the importance of this type of immunological activity in combating cancer.

Encouraging results from both the breast and prostate cancer trials of AE37 warrant further clinical development of AE37, both as mono- and/or combination therapy. The current study provides important biomarker information relevant to identifying those patients who may be expected to benefit most from AE37. Similarly, the information may help guide possible combination studies; i.e., using agents that may enable all patients to respond robustly to AE37 (e.g., checkpoint inhibitors).

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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