Generex Biotechnology Corporation Confirms Conference Call with Members of the Antigen Express Scientific Advisory Board

WORCESTER, Mass. and TORONTO, July 23, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) today confirmed that it will be hosting a conference call with members of the Antigen Express, Inc. (www.antigenexpress.com) Scientific Advisory Board on Wednesday, August 14, 2013 at 10 a.m. EDT. Call-in particulars will be announced prior to the call.

The call will include a discussion of the on-going Phase II clinical trial of the Antigen Express AE37 breast cancer vaccine and the Antigen Express Ii-Key technology platform in the context of current breast cancer treatments and the industry focus on immunotherapeutic approaches to the treatment of cancer, as highlighted at the June 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO).

The call will feature the following members of the Antigen Express Scientific Advisory Board:

• Dr.Gary H. Lyman, MD, MPH, FACP, FRCP (Edin), FASCO;
• Dr. Gabriel N. Hortobagyi, MD, FACP;
• Dr. Ian Krop, MD, PhD;
• Dr. Keith L. Knutson, PhD;
• Dr. James J. Mule, PhD;
• Dr. Hope S. Rugo, MD; and
• Dr. Samuel Jacobs, MD.

In addition, Dr. Elizabeth Mittendorf, MD, PhD, the Principal Investigator on the Antigen Express AE37 breast cancer vaccine Phase II trial, will participate on the panel.

“We are pleased to bring together this panel of key opinion leaders to share their insights into the burgeoning research on immunotherapeutic approaches to the treatment of cancer, where scientists are seeking to enhance the immune system to combat cancer,” commented Mark Fletcher, Generex’s President & Chief Executive Officer. “Recent announcements by Merck and Bristol-Myers Squibb of favourable clinical trial data suggest that immunotherapeutic drugs may significantly impact the treatment of cancer. We look forward to additional data from the Antigen Express AE37 breast cancer vaccine trial this fall as we seek Phase III partnership opportunities in the context of the industry focus on immunotherapeutic treatments of cancer.”

The Antigen Express AE37 vaccine is designed to stimulate the immune system to target HER2 on breast cancer cells at low levels independent of immune type of the person. AE37 targets an early breast cancer patient population of unmet need several times larger than those treated with Herceptin. In particular, while Herceptin is approved for use in roughly 25% of early stage breast cancer patients with high expression of HER2, it is not approved for the larger group of women (50% of women with early breast cancer) who have lower levels of expression of the target for Herceptin (HER2). Rather than attacking HER2 cancer cells directly as does Herceptin, AE37 works by stimulating the immune system to recognize HER2. The greater sensitivity of the immune system can thereby recognize and kill cancer cells in this larger low HER2 expressing early breast cancer population. An additional potential advantage is that the immunological memory induced by AE37 means the immune system may continue to scan for and kill HER2 cancer cells long after AE37 treatment has been completed.

Herceptin is approved for metastatic and early stage breast cancer patients. Its 2010 annual sales were nearly $6 Billion. Given that the initial target population for AE37 in early stage breast cancer patients is twice that of Herceptin, the market potential for AE37 is clear.

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