Last week, the U.S. Food and Drug Administration (FDA) granted "Breakthrough Therapy Designation" for an early-phase brain tumor clinical trial at Duke University that uses re-engineered poliovirus (PVS-RIPO) to treat patients with recurrent glioblastoma multiforme (GBM). This past Sunday, CBS 60 Minutes, aired the second segment of their story about this promising trial.
ABC2 provided early support for this project (in 2002) and also has provided significant support for the Duke Brain Tumor Center in general. The three patients in long-term remission (or, as they said on the show last night “cured”) are rare examples of such outcomes in a landscape that has generally been very bleak. However, this does not yet mean or guarantee that PVS-RIPO is approved for all recurrent GBM patients. The "breakthrough therapy designation" does not automatically move the therapy from Phase I to Phase II, it merely means that the drug developer can get expedited and more interactive, focused review by the FDA.
ABC2 congratulates Duke on their promising research. Once the safety issues are worked out in the Phase I trial, we look forward to their moving to Phase II and expanding the trial.