Generex's cancer vacc well-tolerated

Canadian biotechnology firm Generex reported results from a Phase I clinical trial of AE37, its Ii-Key/HER2/neu MHC class II peptide-based vaccine in breast cancer patients, conducted by its immunotherapy unit, Antigen Express, at the Walter Reed Army Medical Center in Washington DC, USA.

"The Phase I studies have been successful both in establishing the safety of AE37 as well as in determining an optimal biological dose," noted Eric von Hofe, president of AE, presenting the data at the 2006 San Antonio Breast Cancer Symposium, Texas, USA. The product is designed to elicit a specific response against a protein encoded by the HER-2/neu oncogene, which is expressed in a high percentage of various types of cancer. According to AE, the trials have shown that the vaccine is safe, well-tolerated and produces a significant immune response in breast cancer patients.

While the target of AE37 is the same as that of US specialist drugmaker Roche/Genentech's marketed cancer drug Herceptin (trastuzumab), the activity of the vaccine relies on its ability to stimulate a patient's own immune system to recognize the cancer target rather than by interacting with the target directly. The advantage of this is that the immune system, once activated, is capable of detecting lower levels of the target protein than is Herceptin, and that the antitumor activity lasts long after termination of AE37 treatment.