FDA gives breakthrough status to Poliovirus Cancer treatment

A poliovirus cancer treatment designed by Duke medical researchers was awarded rare "breakthrough therapy" status by the Food and Drug Administration to speed up its approval for market use.The FDA's recognition follows Phase 1 clinical trials of the therapy, which have been occurring since 2012 and are held at Duke's Preston Robert Tisch Brain Tumor Center. Medical researchers have found a 20 percent three-year survival rate in patients with glioblastoma, a particularly aggressive form of brain cancer, who received the poliovirus therapy, compared to a historical 4% survival rate. Dr. Darell Bigner, director of the Preston Robert Tisch Brain Tumor Center, said that the team of researchers will meet with the FDA within 60 days to discuss the next steps for future trials, and that they hope to expand the trials to several hundred patients.