WORCESTER, Mass. and TORONTO, April 3, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT.OB) announced today that the American Association for Cancer Research (AACR) chose to spotlight a presentation on data from the ongoing clinical trial of AE37, an immunotherapeutic vaccine to prevent relapse in patients who have had breast cancer being developed by Antigen Express, in a press conference. The annual AACR meeting is one of the largest national cancer conferences in the US, highlighting the most significant advances in all areas of cancer research. It is being held this year from March 31 to April 4 at McCormick Place in Chicago, Il.
The specific presentation highlighted by the AACR is entitled: "Immune response assessment in a phase II trial of AE37 HER2 peptide vaccine" by Dr. Diane Haleet al. The abstract will be available for viewing Tuesday April 3rd from 8 AM to 12 PM. The study examined patients from the controlled, randomized trial of AE37 for immunological response to the vaccine. AE37 consists of a fragment of the HER2 protein modified by proprietary means to increase potency in generating a specific immune response to HER2 expressing cancer cells. The key findings from the study are that patients receiving AE37 indeed developed a specific immune response as indicated by an increase in circulating T cells in their blood specific for the HER2 fragment as well as a positive skin test (delayed type hypersensitivity). In addition, patients receiving AE37 demonstrated a reduction in T regulatory cells, which are know to be able to hamper an immune response.
The AACR press conference was held Monday April 2nd. Dr. Hale gave a brief oral presentation of the study followed by a question and answer period.
"The finding that AE37 generates a specific immune response is consistent with the activity we've observed to date, suggesting that patients receiving the compound have a lower rate of relapse," said Dr. Elizabeth Mittendorf, senior author on the study and Principal Investigator for the trial. "These studies help us to understand at a mechanistic level how the vaccine is working and on a more general level what hallmarks to look for in developing successful cancer immunotherapy."
About AE37 and Ii-Key Hybrid Platform Technology
Antigen Express is a platform technology and product-based company developing proprietary vaccine formulations for large, unmet medical needs. The Company's Ii-Key Hybrid technology platform entails the modification of fragments of antigens to increase their potency in stimulating critical members of the immune response, known as CD4+ T helper cells. Incorporating the Ii-Key modification along with tumor-associated antigens can greatly enhance the immune system's ability to recognize and destroy cancer cells bearing any of the targeted antigens as well as increasing immunological memory.
The first product candidate utilizing the Company's novel Ii-Key Hybrid technology platform is a HER-2/neu Peptide Vaccine (AE37). This "off-the-shelf" cancer immunotherapy product candidate is easier and less costly to produce than comparable cell-based approaches. AE37 is derived from a peptide fragment of the human epidermal growth factor receptor 2 (HER2) oncoprotein, which is expressed in a variety of tumors including 75-80% of breast cancers as well as a high percentage of prostate, ovarian and other cancers. AE37 represents the only HER2-based peptide vaccine currently being studied in a randomized trial and its use is not restricted to patients with a particular type of human leukocyte antigen (HLA) peptide.
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