Antigen Express AE37 Breast Cancer Vaccine Update Primary Efficacy Analysis Initiated for Phase II Study of Novel Immunotherapeutic

WORCESTER, Mass. and TORONTO, Nov. 18, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) today announced that it has reached a pre-specified point in the ongoing Phase II trial of its AE37 breast cancer vaccine to initiate its primary efficacy analysis.  The drug is a novel immunotherapeutic cancer vaccine being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com).  A previously released positive interim analysis showed a strong trend toward reduced relapse in breast cancer patients receiving the AE37 vaccine.

The immunotherapeutic vaccine AE37 is designed to stimulate a robust immune response against the HER2 protein, which is expressed in a large percentage of patients with breast and other cancer types.  While the highly successful drug Herceptin is approved for use only in patients whose tumors express the highest levels of HER2 (roughly 25% of patients), AE37 is targeted to patients whose cancers express even low levels of the HER2 protein.  Not surprisingly, the interim analysis showed that AE37 appeared to perform best in those patients who did not receive Herceptin.  It is particularly this patient population of low HER2 expressing cancer patients that represents one of the largest areas of unmet need among breast cancer patients.

The Phase II trial involves the use of 15 sites in the US and Europe and is being conducted under a company-sponsored Investigational New Drug Application (IND).  The planned analysis will compare disease free survival in AE37-treated versus control patients.  The trial is a single-blinded, controlled, and 1:1 randomized study in patients who have been recently diagnosed with node-positive or high-risk node-negative breast cancer and received standard-of-care therapy.  As the largest cancer vaccine trial conducted to date in breast cancer patients, the results are expected to help foster a partnership for the Company's upcoming Phase III trial.

The Company is presently preparing for a lock of the data, after which it will be analyzed in accordance with the study's statistical analysis plan.  This primary efficacy analysis will be the second formal analysis of data from the trial.  A third analysis is set to occur 12 months after enrollment of the final patient in the study.

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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