Mar. 13, 2000 LOS ANGELES (March 8, 2000) – Researchers at Cedars-Sinai Medical Center’s Maxine Dunitz Neurosurgical Institute have launched a study of a new vaccine intended to prevent the return of malignant brain tumors that have been surgically removed.
According to Keith L. Black, M.D., who directs the Institute, the medical center’s Division of Neurosurgery and its Comprehensive Brain Tumor Program, the vaccine is under development with The Immune Response Corporation (NASDAQ:IMNR), a biotechnology research company in Carlsbad, CA.
“Vaccines are designed to recognize and destroy only tumor cells. They are part of a new generation of therapies based on the latest biologic information about how brain tumors survive and what allows them to grow,” said Dr. Black. “Therefore, rather than bombarding the patient with chemicals and radiation, we’re devising strategies that interfere with the cancer cell’s very existence.”
This study offers new hope toward controlling a cancer of the brain called glioblastoma multiforme, or “gliomas,” that have been particularly challenging and frustrating to physicians and surgeons. Because these tumors tend to grow quickly, invade surrounding tissue, and recur frequently – even when patients are subjected to aggressive therapies – survival rates have historically been extremely low.
“Even when we are able to completely remove a tumor, a small number of malignant cells will almost certainly be left behind. These are typically treated with radiation, which may sometimes be effective in destroying them. But radiation often damages surrounding healthy brain tissue as well,” said Dr. Black, who is regarded as one of the world’s leading neurosurgeons because he often is able to remove tumors previously considered inoperable.
For the past several years, Dr. Black and his colleagues have been studying another vaccine that was developed at the Institute. Although their findings have not yet been published, Dr. Black said preliminary results of the “dendritic cell vaccine” appear to be “very promising.”
The dendritic cell vaccine is created from the cells of a tumor that has been surgically removed. In a Petri dish, foreign proteins extracted from the tumor are introduced to antigen-presenting (or dendritic) cells taken from the patient’s blood. The resulting new dendritic cells, when re-injected into the patient, are intended to recognize and destroy any lingering malignant tumor cells. Several injections are typically scheduled over a six-week period.
The new vaccine being developed with The Immune Response Corporation combines established tumor cells with fibroblasts that are genetically modified to release a specific cytokine called GM-CSF. Cytokines are proteins that are known to stimulate the immune system. GM-CSF has been found in animal studies to be the most effective cytokine in treating tumors of the central nervous system.
“The advantage of this vaccine over the dendritic cell vaccine is that we’re using tumor cells and GM-CSF secreting fibroblasts that The Immune Response Corporation has in a bank. Because the vaccine is readily available, we can avoid the additional step of making a vaccine from the patient’s own tumor,” said Dr. Black. The vaccine will be administered under the skin four times at two- to four-week intervals.
The Phase I clinical trial, expected to be completed within a year, has received approval from the Food and Drug Administration.
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