Generex Biotechnology has announced that recent results from a phase II study of a novel cancer vaccine designed to prevent relapse in patients who have had breast cancer corroborate prior results from an interim analysis conducted in October of 2011.

The AE37 cancer vaccine is being developed by the company's wholly-owned subsidiary, Antigen Express. It is designed to stimulate an immune response against the patient's cancer cells, preventing relapse in patients who have been treated for early stage breast cancer.

The recent analysis is based on data from nearly 300 patients, making this the largest controlled and randomized trial of a breast cancer vaccine trial conducted to date. While full analysis of the recent results is still in progress, the data corroborate qualitatively the data reported after an interim analysis conducted two years ago. Specifically, the more prevalent population of breast cancer patients ineligible to receive the drug Herceptin, and particularly those in high-risk groups (e.g., triple negative breast cancer), appear to benefit most from AE37.  Both of these patient populations represent areas of significant unmet need.

The immunotherapeutic AE37 is designed to work indirectly by stimulating the patient's immune system to recognize and kill cancer cells. An advantage of the compound is that it potently activates a subclass of immune cells, known at CD4+ T cells, without sacrificing tumor target specificity. This subclass has been shown to be critical in generating a robust, long-lasting and effective immune response. AE37 consists of a fragment of the tumor-associated HER2 protein modified by a proprietary platform technology developed by Antigen Express scientists.

The company previously has been given the green light by the FDA to submit a protocol for a phase III study of AE37. In addition to breast cancer, the company has also completed a phase I trial of AE37 in patients with prostate cancer. Along with cancers of the breast and prostate, a variety of other cancers such as ovarian, colon and lung cancer similarly express some level of HER2 and may be considered for future AE37 trials.