FDA grants breakthrough status to polio virus for glioblastoma

The FDA granted breakthrough status to an experimental treatment that uses the poliovirus to treat glioblastoma, an aggressive form of brain cancer.

Researchers at Preston Tisch Brain Tumor Center at Duke University Medical Center have investigated use of a genetically engineered poliovirus in which the disease-causing ability of the polio is removed by splicing a rhinovirus into its genome.

The reengineered virus — which is infused into glioblastoma tumors — is designed to infect and kill tumor cells while activating the immune system.

Preliminary results of a phase 1 trial were presented at the Society for Neuro-Oncology meeting in 2014.

The television news program 60 Minutes spotlighted the Duke trial last year. Although 11 of 22 patients enrolled in the trial had died by the time the show aired, a few patients experienced unprecedented outcomes. Survival appeared dramatically better than in any prior dataset, with some patients achieving complete clinical and radiographic responses.

Principal investigator Matthias Gromeier, MD, associate professor in the department of neurosurgery at the brain tumor center, spoke to HemOnc Today last fall about the trial as part of a cover story that explored research advances in neuro-oncology.

At that time, Gromeier said he considered the results “remarkable.”

“We have learned a great deal about how to institute this therapy and how to manage toxicity, and we have arrived at what is probably an optimal use of this agent as far as we can understand it,” Gromeier told HemOnc Today.

Other neuro-oncologists who spoke with HemOnc Today for that cover story acknowledged the data appeared promising but emphasized the findings were part of a phase 1 trial and it may be too early to make definitive assessments of the novel therapy.