WORCESTER, Mass. and TORONTO, Feb. 7, 2013 /PRNewswire/ -- Generex Biotechnology Corporation ( www.generex.com) (OTCBB:GNBT) today provided an overview of the current pipeline and potential of its wholly-owned subsidiary Antigen Express, Inc. ( www.antigenexpress.com). While the Company is currently in a late Phase IIb trial of a very promising new immunotherapy for early breast cancer (AE37), the Company has made concrete headway in demonstrating a robust pipeline for AE37 indications beyond breast cancer, as well as for the technology behind it. Immediately behind its Phase III-ready breast cancer program, the Company has completed a Phase I prostate cancer trial and established a protocol for Phase II . While Herceptin targets the same tumor-associated protein as does AE37 therapy, Herceptin is not approved for breast cancer patients with low levels of HER2 expression, limiting Herceptin treatment to roughly 25% of breast cancer patients. Low levels of HER2 protein have been shown on several cancers, including men with prostate cancer. AE37 is being further researched in this larger population of patients whose tumors express only low levels of HER2.
While breast and prostate cancers are the initial indications being investigated for AE37, nearly all cancers of the gastrointestinal tract as well as lung, ovarian, bladder, and other cancers also express low levels of HER2. AE37 future research may help establish its role in many cancers in addition to breast and prostate cancer. A unique aspect of Antigen Express technology, which has enabled the promising results obtained so far from the AE37 Phase IIb trial in early breast cancer, is the Ii-Key technology platform. This technology enhances delivery of key target proteins like HER2 for cancer to a critical immune recognition site enhancing immune recognition. The Company has also developed compounds designed for important non-HER2 cancer associated protein targets using the Ii-Key technology platform. These include the melanoma-associated gp100 target, as well as cervical and head-and-neck cancers associated with Human Papilloma Virus (HPV). These compounds have shown significant activity in animal models that has been described in peer-reviewed publications.
In addition to cancer protein targets, the Company has clinically tested Ii-Key-based proteins designed to protect against the potentially pandemic influenza strains H5N1 (avian flu) and H1N1 (swine flu). The advantage here is that the Antigen vaccine technology is entirely synthetic, making it simple to manufacture. In the event of a potentially pandemic influenza virus, there is clearly a need for this type of flexible vaccine technology that can be brought into production rapidly.