Cell fusion vaccine approach being tested.

2002 DEC 11 - (NewsRx.com & NewsRx.net) -- Genzyme Molecular Oncology (GZMO) launched a new clinical trial in kidney cancer that uses an innovative vaccine made from combining the patient's own cancer cells with powerful, immune-stimulating cells to fight the devastating disease.

Genzyme Molecular Oncology, a division of Genzyme Corporation, is the first commercial entity in the United States to pursue development of patient-specific cancer vaccines produced using this electrical fusion approach.

The phase I/II kidney cancer trial is now enrolling patients in Boston at the Beth Israel Deaconess Medical Center. Enrollment also is expected to begin shortly at the Dana-Farber Cancer Institute. David Avigan, MD, director of the bone marrow transplant program at the Beth Israel Deaconess Medical Center and assistant professor at Harvard Medical School, is the lead investigator of the trial and participated in preclinical evaluation of this fusion approach.

Up to 20 patients with advanced kidney cancer are expected to be treated in the trial. The vaccine will be administered over the course of 12 weeks. Genzyme Molecular Oncology will assess the vaccine's safety, and seek to measure any clinical and immunologic responses in the patients.

"Kidney cancer is a particularly difficult disease for which treatment options are limited," stated Avigan. "Our hope is that this vaccine approach will prove to be safe and effective without harmful side effects. We also hope to demonstrate the potential of innovative vaccines for the treatment of cancer."

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, Massachusetts, specifically designed and built for the production of ...