Generex expands vaccine trials to include prostate cancer

AE37 is a novel immunotherapeutic vaccine being developed by Generex’ wholly owned subsidiary Antigen Express. The compound has been in clinical trials for more than a year at the Walter Reed Army Medical Center in patients with breast cancer and has shown good immune stimulatory activity. Due to these positive results, Generex said it was deemed appropriate to expand studies into prostate cancer.

The synthetic peptide vaccine is designed to stimulate a potent and specific immune response against tumors expressing the HER-2/neu oncogene. Previous clinical studies have shown that it is safe and generates a dose-dependent immunological response in inoculated patients.

As advanced cases of prostate cancer express the HER-2/neu oncogene, it was decided to begin a separate study with these patients. A strong immune response against HER-2/neu offers the potential to kill tumor cells that have spread to parts of the body distant from the primary tumor. In addition to breast and prostate cancer, a significant percent of other cancers, including ovarian, stomach, pancreatic and lung cancers, also express the HER-2/neu target.

The clinical studies are an extension both of the current clinical trials at the Walter Reed Army Medical Center, as well as a collaboration with Dr Constantin Baxevanis at the Saint Savas Hospital in Athens, Greece.

The new prostate cancer studies will involve 30 patients, looking predominantly at immunological responsiveness to a dose of the vaccine previously shown to be well-tolerated in breast cancer patients. However, imaging studies to monitor disease progression will be performed at the end of the six-month course of therapy or earlier should there be indications of therapeutic benefit.