WORCESTER, Mass. and TORONTO, March 14, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT) announced today that a review of the Antigen Express proprietary platform technology for generation of immunotherapeutic vaccines has been published in the peer-reviewed journal Vaccine. The Company is developing therapeutic vaccines for serious unmet medical needs, such as cancer.
The article, entitled "CD4+ T-cell activation for immunotherapy of malignancies using Ii-Key/MHC class II epitope hybrid vaccines", reviews preclinical and clinical studies from the last ten years to the present time demonstrating the importance of generating specific CD4+ T-cell activation in the immunotherapy of cancer. In addition, the rationale and development of the Company's Ii-Key technology from its discovery in the late 1990's to currently ongoing clinical trials of its lead compound in breast cancer patients is described.
"We are pleased to be able to present our Ii-Key technology in the journal Vaccine," said Dr. Eric von Hofe, President of Antigen Express and senior author of the review. "The technology offers a simple and effective method to potently and specifically increase CD4+ T-cell activation, which on its own is beginning to show signs of clinical efficacy and would certainly augment most other vaccine strategies," he added.
The Company recently released positive interim data from a Phase II efficacy study being performed with its lead Ii-Key compound, AE37, in patients with breast cancer. The study is designed to test for a reduction in relapse in patients who have had standard of care treatment for breast cancer in a controlled and randomized study.About AE37 and Ii-Key Hybrid Platform TechnologyAntigen 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.