University of Alabama at Birmingham Pediatric Oncologist Gregory Friedman has been awarded a three-year, $750,000 R01 grant for a phase 1 immunotherapy clinical trial in his research to fight malignant cerebellar brain tumors in children.
With the U.S. Food and Drug Administration grant, Friedman and his team will continue to work to advance the therapy to a phase 2 clinical trial based on the promising results to date. Friedman’s team is using engineered cold-sore (herpes) virus G207 injections into pediatric tumors in the back of the brain or cerebellum.
“There are unique challenges to treating tumors in the cerebellum, and this will be the first-in-human study of an oncolytic herpes virus inoculated in that location,” Friedman said. “Previously, all studies using similar viruses have focused on tumors either outside of the brain or in the cerebrum, the main part of the brain.”
Standard therapies, such as chemotherapy or radiation, are very damaging to a child’s developing brain and too often are ineffective. Viral immunotherapy offers a potentially targeted, less toxic and more effective approach.
G207 is a herpes virus that has been genetically altered so that it does not harm normal cells but can infect and kill tumor cells. When infused into a malignant brain tumor, the virus replicates and kills the cells, while releasing the virus’ progeny to infect and kill other tumor cells nearby. The virus also triggers a strong immune response from the body, which can then attack and kill the tumor and potentially prevent tumor progression or recurrence.
The primary goal of the trial is to demonstrate the safety and tolerability of the treatment in children with malignant cerebellar brain tumors, with a secondary aim of assessing the effectiveness of the therapy and the immune response generated by the treatment.
Friedman is an associate professor in the UAB Division of Pediatric Hematology-Oncology in the Department of Pediatrics, a physician at Children’s of Alabama and an associate scientist in the O’Neal Comprehensive Cancer Center.