Generex Biotechnology Corporation's wholly-owned subsidiary, Antigen Express, Inc. announced that its lead drug candidate AE37, a novel HER-2/neu-targeted vaccine currently in phase II development for the treatment of breast cancer, is featured in the October 2011 issue of Scientific American, in a story titled “A New Ally Against Cancer” by Eric von Hofe, PhD, president of Antigen Express (http://www.scientificamerican.com/article.cfm?id=a-new-ally-against-cancer).

The article highlights recent advances in the field of cancer immunotherapy. It describes how previous adoptive immunotherapy using just CD8+ cells had shown no benefit and that cancer vaccines would have to elicit both CD4+ and CD8+ cells to be effective. AE37 is also described as a peptide-based vaccine that uses bits of the HER-2/neu protein that are small in size, inexpensive to synthesize and very easy to manipulate, which means that they can be readily formulated into a vaccine that is simple to manufacture in large amounts. This is in stark contrast to autologous cell-based therapies, such as Provenge, which are costly and labour intensive.

The article also states that in spite of previous obstacles and complexities, “the signs are clear: a patient's own immune system can be effectively enlisted to help combat cancer.”

“We are pleased to be featured in Scientific American to review our pioneering work in the field of cancer immunotherapy and look forward to future articles and peer reviewed publications documenting our scientific and clinical trial developments. Coinciding with Breast Cancer Awareness Month in October, the article also underscores our commitment to developing AE37 for the treatment of breast cancer and other indications,” stated Dr von Hofe.

Antigen Express' novel Ii-Key Hybrid Preventive HER-2/neu Peptide Vaccine (AE37) is an "off-the-shelf" cancer immunotherapy product candidate that is easier and less costly to produce than comparable cell-based approaches. AE37 is derived from a fragment of the HER2 oncoprotein, which is expressed in a variety of tumours including 75-80 per cent of breast cancers as well as a high percentage of prostate, ovarian and other cancers. AE37 is positioned initially as an adjuvant therapy for at least 50 per cent of breast cancer patients; i.e., those with low-to-intermediate levels of HER-2 expression who are not eligible for treatment with trastuzumab (Herceptin). Only 25 per cent of breast cancer patients have HER-2 levels high enough to be eligible for Herceptin.

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 patients not receiving AE37. 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 could be obtained in 2012, the company opted to enroll an additional 100 patients in early 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 trastuzumab. It is anticipated that a planned phase III trial will be conducted in this specific patient population.

Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies.