2014

Generex Announces Completion of Enrollment of Antigen Express Phase II AE37 Breast Cancer Vaccine Trial

WORCESTER, Mass. and TORONTO, Jan. 13, 2014 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today announced completion of enrollment of the Antigen Express, Inc. (www.antigenexpress.com) AE37 breast cancer immunotherapy trial.  The clinical trial is designed to assess the ability of AE37 to reduce the risk of relapse in patients who have had breast cancer.  While a pre-planned primary efficacy analysis is underway, completion of enrollment sets the time-point for the end-of-trial analysis, scheduled to be conducted one year's time.

"This represents a significant milestone for Generex and Antigen Express," said Mark Fletcher, President & Chief Executive Officer of Generex.  "Completion of enrollment of the Phase II, together with our primary efficacy analysis, puts us in an ideal position to take advantage of the groundswell resurgence of the promise of cancer immunotherapy."  Representatives of both Antigen Express and Generex are currently attending the J.P. Morgan Healthcare Conference in San Francisco in response to enquiries from interested third parties.

The Phase II trial has enrolled over 300 patients at 15 sites in the US and Europe, making it the largest controlled, randomized, and single-blinded world-wide breast cancer vaccine study conducted to date.  Patients enrolled in the trial have been previously diagnosed with node-positive or high-risk node-negative breast cancer and have received standard of care therapy.  They were enrolled at the early stages of disease with the intent to establish the ability of AE37 to reduce the incidence of relapse.  An interim analysis conducted on data obtained through October of 2011 showed a strong trend suggesting that this was indeed the case.

AE37 is a synthetic, off-the-shelf therapeutic vaccine designed using a fragment of the HER2 protein together with a proprietary modification developed using the technology platform of Antigen Express.  The modification has been shown to activate CD4+ T helper cells, which are critical in the development of an immune response, in a HER2-specific manner.  In addition to CD4+ T cell activation, immunological studies of treated patients show a reduction of immune-suppressor cells, suggesting that the Antigen Express modification may have multiple modes of action. 

Based on results from the interim analysis conducted previously, the Company was given a green light by the FDA to proceed with submission of a Phase III protocol.  That study has been designed to focus on patients with low levels of expression of the HER2 protein who are not eligible to receive Herceptin.  This population of breast cancer patients is nearly double that which is eligible for Herceptin treatment and thus represents an area of significant unmet need and an untapped market segment.

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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