Generex Biotechnology expands of ANtigen express cancer trials to include prostate cancer patients

Clinical trials are initiated at the Euroclinic in Athens, Greece

10-Aug-2006

Generex Biotechnology Corporation has entered into an agreement with the Euroclinic in Athens, Greece to commence clinical trials on a novel immunotherapeutic vaccine being developed by its wholly-owned subsidiary Antigen Express, Inc. 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. Because of these positive results, it was deemed appropriate to expand studies into patients with prostate cancer.

The compound being developed, AE37, is a synthetic peptide vaccine 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. Because 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 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.

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