Generex Provides an Overview of its Cancer Immunotherapy Product, AE37, and Potential in Early Breast Cancer Given Current and Potential Future Therapies

WORCESTER, Mass. and TORONTO, Jan. 30, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) today provided an overview on the early breast cancer competitive status of the lead cancer immunotherapy product, AE37, under development at its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com).  A detailed update on development plans will be provided during the previously announced conference call scheduled for Thursday, January 31, 2013.  Antigen Express is in late Phase IIb clinical development for early stage breast cancer that has provided very encouraging interim results and Phase I testing in prostate cancer has been completed.

The specific advantage of the cancer immunotherapy product AE37 is in early breast cancer by potentially stimulating the immune system to target HER2 (the target for Herceptin's effect) on breast cancer cells at low levels independent of immune type of the person. This follows in the footsteps of one of the most successful therapeutics ever developed for breast cancer (Herceptin), though AE37 potentially addresses an early breast cancer patient population of unmet need several times more common 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 be brought to bear to 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 $6B. Given that the initial target population for AE37 in early stage breast cancer patients is twice that of Herceptin, AE37 has the potential to achieve blockbuster status.

The potency of AE37 derives from a fragment of the HER2 protein combined with a proprietary modification developed at Antigen Express. While similar fragments of HER2 are also in clinical development for early stage breast cancer patients with low HER2 expression, they lack the potency of AE37. Further, their mechanism of action requires use to be limited to a sub-group of people with a specific genetic immune type. The clinical use of these alternative HER2 immune fragments therefore must exclude roughly half of the women with early breast who would otherwise be eligible. No genetic immune limitation or exclusion from clinical use is required for AE37 treatment. Any market competition in early breast cancer from these alternate HER2 fragments would be limited to the genetic immune sub-group, with AE37 facing no competition in patients excluded from other treatments. Further, additional genetic immune profile testing adds another diagnostic step before a woman with early breast cancer could get a potential new treatment. Any agents requiring additional testing may be at a competitive disadvantage.

Another advantage that sets AE37 apart from other types of related vaccines is that it contains a proprietary modification that is exclusive to Antigen Express. The modification, termed Ii-Key, derives its name from the immune regulatory molecule from which it is derived (Ii protein) and the fact that it functions as a 'key' to deliver its payload (HER2 fragment) to critical components of the immune system that ensure generation of a robust and specific immune response. What makes this modification unique is that it amplifies the vaccine potency of the HER2 fragment without loosing specificity, unlike many non-specific immune stimulants. The Ii-Key modification can be added to many different 'payloads' to generate a specific and robust immune response. Given the increasing interest in cancer immunotherapy, this will be very attractive to companies wishing to 'supercharge' their specific vaccines.

The positive interim data of the AE37 trial have received particular attention given the robust and well-designed nature of the Phase IIb trial. In addition to being the only randomized, controlled and blinded study conducted with this type of HER2 targeted immunotherapy, it is also the largest vaccine therapy study conducted in the adjuvant breast cancer setting to date (330 patients). In recognition of the quality of the trial and encouraging results, the abstract reporting the interim results was recognized with a 2012 American Society of Clinical Oncology (ASCO) Merit Award bestowed by the Conquer Cancer Foundation and the 2012 Scientific Program Committee of ASCO. Further, the FDA has given the company the green light to proceed with submission of a Special Protocol Assessment for the Phase III trial.

Antigen Express is well positioned to execute on its business model, which includes potential out-licensing of additional clinical development of its lead compound in early breast cancer while pursuing additional products using its proprietary immunotherapy Ii-Key technology platform upon which AE37 is based. The advancement of AE37 in breast cancer clinical development will help to validate the company's immune technology platform. Low expression of the HER2 target is widespread among a variety of cancers including breast, prostate, ovarian, lung and cancers of the GI tract suggesting potential future areas for clinical research. Additionally, there are many other cancer targets similar to HER2 for which Antigen Express could design immune targeting compounds as along the linesAE37 targetsHER2.

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