Cleveland Clinic is now enrolling patients in a Phase I/II clinical trial in kidney cancer conducted by Genzyme Molecular Oncology. Ronald Bukowski, of the Cleveland Clinic, is the lead investigator of the trial at this site. Genzyme Molecular Oncology, a division of Genzyme Corporation of Cambridge, MA, is the first commercial entity in the United States to pursue development of patient-specific cancer vaccines produced using this electrical fusion approach.

The multi-center study is also underway in Boston at the Beth Israel Deaconess Medical Center and Dana-Farber Cancer Institute. It uses an innovative vaccine made from electrically combining the patient's own cancer cells with powerful, immune-stimulating cells to fight the devastating disease.

Up to twenty patients with advanced kidney cancer are expected to be treated in the trial. The vaccine will be administered over the course of twelve weeks. Genzyme Molecular Oncology will assess the vaccine's safety, and seek to measure any clinical and immunologic responses in the patients.

The vaccine to be used in this trial is produced by Genzyme Corporation using an approach in which cancer cells surgically removed from the patient are electrically combined with powerful, immune-stimulating (dendritic) cells. These newly combined cells are then delivered back to the patient in the form of a vaccine, through multiple injections into the upper thighs and lower abdomen. Through this approach, it is believed that the vaccine then enables, or "educates," the patient's immune system to recognize the remaining cancer cells as foreign to the body, and attack them.

Except for the removal of the patient's cancer cells in the hospital, all other aspects of the vaccine production will take place in Genzyme's state of the art, manufacturing facility in Framingham, MA specifically designed and built for the production of cell-based therapies.

"As seen in pre-clinical studies, the electrofusion approach harnesses the genetic machinery of the body's immune system and uses it to directly target cancer cells," stated Michael Vasconcelles, Senior Medical Director for Genzyme Molecular Oncology. "The approach offers the potential to specifically kill the cancer without harming the patient's healthy cells - an exciting prospect when considering that kidney cancer is known to spread widely throughout the body."

Genzyme Molecular Oncology expects patient enrollment and the majority of patient treatment to be completed during 2003.