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.
The many clinical trials conducted in the field of active immunotherapy of cancer over the last decade have provided increasing evidence that it is possible to engage the immune system to focus on and destroy cancer cells. Part of what has been learned over this time is the importance of specific activation of CD4+ T-helper cells in the generation of a robust and effective immune response. Equally clear is the validity of the HER2 protein as a target for cancer therapy. Importantly, HER2 is expressed at low to intermediate levels in a high percentage of breast as well as many other tumor types. HER2 expression at these levels requires active immunotherapy, such as AE37, rather than passive immunotherapy such as Herceptin. For this reason, the company is continuing with plans for a Phase II prostate cancer study as well as other novel clinical applications of AE37 with interested parties.
"Antigen Express continues to make progress
|SOURCE Generex Biotechnology Corporation|
Copyright©2010 PR Newswire.
All rights reserved