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 tumours 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 tumour cells that have spread to parts of the body distant from the primary tumour. 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 collaboration with Dr. Constantin Baxevanis at the Saint Savas Hospital in Athens, Greece. Dr. Baxevanis is an internationally recognized investigator in the field of tumour immune responses and HER-2/neu expression. He has been involved in preclinical studies of AE37 with Antigen Express scientists. The Euroclinic Athens is a private centre dedicated to diagnostics and therapeutic patient support as well as surgery.
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.
"We are excited at the prospect of beginning clinical trials in Europe," said Dr. Eric von Hofe, President of Antigen Express. "The results to date have been very encouraging and warrant expansion of our AE37 immunotherapy trials. While cytotoxic agents clearly have their place in cancer chemotherapy, it is imperative to aggressively pursue less toxic immunotherapy strategies." The same technology used to enhance immunogenicity in AE37 is being applied by Antigen Express in its development of a synthetic peptide vaccine for H5N1 avian influenza.
Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs).