Generex/Antigen Express Announce Database Lock of AE37 Breast Cancer Vaccine Trial

WORCESTER, Mass. and TORONTO, Jan. 6, 2014

In accordance with the Generex/Antigen Express Clinical Research Standard Operating Procedures, including the quality control standards set forth therein, data collection, validation, reconciliation, and query resolution procedures have been completed.  The database has been finalized and extracted and submitted to the Antigen Express project statisticians for analysis pursuant to the trial's statistical analysis plan.  Preliminary results are expected in January, 2014.

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.  As expected, the interim analysis showed that AE37 appeared to perform best in those patients who did not receive Herceptin.  This patient population of low HER2 expressing cancer patients represents one of the largest areas of unmet need among breast cancer patients.

The Phase II trial, involving the use of 15 sites in the US and Europe, and is being conducted under the auspices of The Henry M. Jackson Foundation for the Advancement of Military Medicine pursuant to 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.  This is the largest cancer vaccine trial conducted to date in breast cancer patients.

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