Poliovirus therapy against cancer given ‘breakthrough’ status by FDA
A treatment for advanced glioblastoma brain tumors based on poliovirus was granted “breakthrough therapy designation” by the U.S. Food and Drug Administration, according to researchers who developed it.
A phase 1 clinical trial of the drug has been ongoing since 2012 after being developed at Duke University, with researchers saying the FDA designation will allow for a more efficient path of testing and reviewing the drug’s efficacy.
Breakthrough designation for a drug does not mean it has been approved for use to cure disease, but rather that it shows the potential to represent a breakthrough in the long run after thorough testing, according to Dr. Richard Moscicki, deputy director for science operations in the FDA’s Center for Drug Evaluation and Research.
The treatment is based on a modified version of poliovirus that cannot invade cells, preventing infection by the deadly disease, but is attracted by cancer cells — which it can invade and kill — while also motivating the immune system to respond to the tumor.
The university is working to expand its trials of the drug to children with brain cancer, enrollment for which is expected to start by the end of 2016. Additional studies are already being conducted with lab models of breast cancer, and additional federal grants will allow researchers to study the treatment’s effects on solid tumors.