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Newswise – A viral immunotherapy using a herpes virus to treat brain tumors has been proven safe and well tolerated in a pediatric study of the University of Alabama at Birmingham and Children's of Alabama. The findings, presented today at the International Symposium on Pediatric Neuro-Oncology in Denver, also showed preliminary evidence of efficacy in the destruction of malignant tumor cells.
The virus, known as G207, is derived from the herpes virus responsible for herpes labialis. The virus is genetically modified so that it only infects tumor cells. When it is perfused into a malignant brain tumor, the virus enters the tumor cells and replicates itself. This kills the cell and releases the offspring of the virus to drive out other tumor cells. In addition, the virus induces a strong immune response by the body's immune system, which can attack the tumor.
Six pediatric subjects were treated with G207 in the current trial. No dose limiting toxicity or serious side effects have occurred. Five of the six patients had evidence of tumor destruction by the virus, including one patient who spent more than 18 months with a continuous response to treatment without further treatment.
"Our results indicate that G207 is safe and tolerable in children with progressive malignant brain tumors," said Gregory Friedman, MD, principal investigator of the study and badociate professor at the UAB Division. Pediatric hematology-oncology at the Department of Pediatrics, and Children of Alabama and a scientist badociated with the UAB Comprehensive Cancer Center. "Preliminary evidence of efficacy is very promising so far.The next phase of the study will test the safety of G207 badociated with a single dose of low-level radiation, used to enhance viral replication and the immune response against the tumor, within 24 hours after the virus inoculation. "
Brain tumors are the most common solid tumor in children, and aggressive types like glioblastoma have an extremely high survival rate low: as low as 10% five years after diagnosis. Even tumors treated successfully with surgery, radiotherapy and / or chemotherapy have a high rate of recurrence and death.
The use of genetically engineered oncolytic viruses, those that selectively kill cancer cells as treatment for brain tumors and other cancers, is the fruit of more than 20 years of research at the UAB by James Markert, MD, MPH, chairman of UAB's Department of Neurosurgery and Principal Investigator at the UAB Comprehensive Cancer Center. The concept was described in the literature in 2001 by Markert and his colleagues. A second generation virus, called M032, was developed by Markert and colleagues Yancey Gillespie, Ph.D., professor of neurosurgery, and Richard Whitley, MD, professor emeritus of pediatric infectious disease, and is in clinical trials at the UAB in adults with glioblastoma, the most lethal of primary brain tumors.
Friedman says the virus's ability to kill a cancer cell is valuable, but the real benefit comes from its effect on the immune system. Cancer cells are very effective at preventing detection by killer T cells of the immune system, meaning that the body does not recognize or trigger a vigorous immune response to brain tumors. G207 appears to stimulate the immune system, causing a robust and continuous immune response in some patients.
M032 goes even further by introducing a cytokine called Interleukin-12, which acts on neighboring lymphocytes and natural killer cells to induce an even stronger anti-tumor immune response. It also inhibits angiogenesis – the creation of new blood vessels – thus closing the blood supply to tumor cells, denying oxygen and essential nutrients.
"High-grade glioma is a devastating diagnosis," Friedman said. "We have made very little progress in developing effective therapies over the last 10-15 years." Viral immunotherapy holds great promise for treating all types of malignant brain tumors, although this approach needs to be investigated more in detail.But, I think we are on the verge of a major development. "
Funding for the clinical trial is provided by the US Food and Drug Administration, and funding to develop this therapy was provided by the NIH / NCI, Department of Defense, St. Baldrick Foundation, Rally Foundation for Cancer Research in Children, Cannonball Kid's Cancer Foundation, Hyundai Hope on Wheels, Vs Foundation of Cancer and Truth 365.
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