Genetically Modified Poliovirus Granted “Breakthrough” by FDA for Glioblastoma
The United States Food and Drug Administration (FDA) has granted “breakthrough status” designation for the treatment of glioblastoma containing a genetically modified poliovirus.
Glioblastoma is an extremely aggressive form of brain cancer, with few patients surviving 5 years following diagnosis. Despite efforts with surgery, chemotherapy, and/or radiation therapy, the overall outcomes for patients with glioblastoma remain suboptimal.
Researchers from Duke University have been testing a novel type of treatment that includes large doses of the genetically modified poliovirus. Through genetic manipulation, the poliovirus attacks cancer cells, but does not have the ability to spread throughout the body and cause harm.
Preliminary testing of this treatment in glioblastoma patients has demonstrated impressive results in both long-term outcomes for these patients, as well as safety issues. Ultimately, these results led the FDA to grant the therapy breakthrough status.
Dr. Darell Bigner, the lead of the poliovirus team at Duke University that has developed and researched this treatment stated that “Breakthrough status means that we can work with the highest levels in the FDA to develop the most efficient clinical trial and pathway to fully evaluate the safety and efficacy of the genetically modified poliovirus for treating recurrent glioblastoma.”
He also stated that “Ultimately, we hope the therapy will one day obtain FDA approval.”
Clinical trials have now opened for the treatment of children with brain cancer, as well as other types of cancers.
As treatment for cancer has recently taken a dramatic turn towards immunotherapy and personalized therapy approaches, the genetically modified poliovirus therapy demonstrates yet another example in how researchers and physicians are changing the way in which cancer is being treated.
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