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 tumors including 75-80% 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% 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% 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 3 trial will be conducted in this specific patient population.
About Generex Biotechnology Corpo
|SOURCE Generex Biotechnology Corporation|
Copyright©2010 PR Newswire.
All rights reserved