Generex Announces Publication of Studies with the Mayo Clinic Confirming and Extending the Antigen Express Ii-Key Platform Technology

 

WORCESTER, Mass. and TORONTO, July 11, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) announced today the publication of studies conducted at the Mayo Clinic using the Antigen Express proprietary Ii-Key technology.  Antigen Express, Inc., the Company's wholly-owned subsidiary, has used this technology platform in the development of self-potentiating immunotherapeutic vaccines for cancer.  AE37, an Ii-Key HER-2 hybrid, is currently the subject of a controlled, randomized, and single-blinded Phase II clinical trial in patients with HER-2 expressing breast cancer.
 

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The publication, entitled "MHC Class II Epitope Nesting Modulates Dendritic Cell Function and Improves Generation of Antigen-Specific CD4 Helper T Cells," was published in the peer-reviewed Journal of Immunology (www.jimmunology.org).  A significant finding of the report, conducted in a mouse model, was that specific CD4+ T cell (T-helper) activation by Ii-Key hybrids excludes T regulatory (immune suppressor) cells.  T regulatory cells (immune suppressor) may hinder active immunotherapy of cancer.  The lack of activation of this cell type has been observed previously in clinical studies of AE37 (an Ii-Key-HER-2 hybrid), both in breast as well as prostate cancer patients.

The senior author of the study, Dr. Keith Knutson, has been one of the pioneers in the field of CD4+ T-helper cell stimulation for active immunotherapy of cancer.  "We are pleased to see this further confirmation of the potential of our technology," said Dr. Eric von Hofe, President of Antigen Express.  "Dr. Knutson has been one of the most important leaders in the field.  The confirmation of the lack of T regulatory cell activation, known to have immune suppressive effects, adds to our prior findings and suggests Ii-Key hybrids could have potential in the field of cancer immunotherapy," he added.  Jos van der Woert, who has accepted the position of Chief Executive Officer of Antigen Express, commented:  "This study further supports the differentiating profile of AE37 with other cancer immunotherapies and provides additional momentum to AE37's clinical development."

Prior clinical studies of an Ii-Key hybrid peptide being developed by Antigen Express, AE37, including a Phase I trial in patients with prostate cancer and a separate trial in patients with breast cancer, have been reported as the subject of four publications in leading peer-reviewed journals.  In brief, those studies showed that AE37 is safe, well-tolerated, and produced immunological responses that were above-and-beyond what had been hoped for.  When compared with two other HER-2 vaccines that have been evaluated in the clinic, AE37 produced the greatest HER-2-related delayed-type hypersensitivity (DTH) reactions in immunized patients.  Of all immunological responses examined in patients undergoing active immunotherapy for cancer, it has been argued that a strong DTH response most reliably predicts efficacy.  In addition, it was found that AE37 was the only peptide able to generate an immunological response when administered without an adjuvant (co-stimulatory agent).  Finally, (as indicated above) AE37 also was the only peptide shown to decrease the level of T regulatory cells.

A controlled, randomized, and single-blinded Phase II clinical study of AE37 in HER-2 expressing breast cancer patients is currently underway to establish clinical efficacy.  The study endpoint is a reduction in cancer relapse after two years compared to the current standard of care treatment.  There are currently over 200 patients enrolled in the study with either node positive or high-risk node-negative breast cancer.  While positive preliminary results suggested that statistically definitive results may be obtained in 2012, it was decided to enroll an additional 100 patients early in 2011 to ensure sufficient patient numbers.  In particular, these additional patients are required to have low HER-2 expression levels such that they are not eligible for Herceptin.  Although 75% of breast cancer patients have some level of HER-2 expression and are eligible for AE37, only 25% have HER-2 levels high enough to be eligible for Herceptin.  The population of patients with low-to-intermediate levels of HER-2 expression currently has no treatment option.  For this reason, it is anticipated that a Phase III trial will be conducted in this specific patient population having low-to-intermediate HER-2 expression levels.

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 in immunotherapy.  One of its platform technologies 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

CONTACT: Investor Relations, Generex Biotechnology Corporation, Todd Falls, +1-800-391-6755; or Seahawk Capital Partners, Inc., Joseph Moscato, +1-646-599-6222; or Media, Beckerman Public Relations, Jerry Schranz, +1-201-465-8020, jschranz@beckermanpr.com

Web Site: http://www.generex.com
 

Posted: July 2011

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