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| Image courtesy Duke Health |
The early stage clinical trial results of the poliovirus therapy were presented June 26 at the 22nd International Conference on Brain Tumor Research and Therapy in Norway and simultaneously published in June 26, 2018 The New England Journal of Medicine.
The therapy includes a genetically modified form of the poliovirus, which is infused directly into the brain tumor via a surgically implanted catheter. The modified virus preferentially targets glioblastoma tumor cells, triggering an inflammatory response.
The objective of the early stage trial, called a Phase I trial, was to determine a safe dose, and usually starts with a low dose and gradually increases the dose to find the optimal dose, meaning the most effective dose with the least amount of side effects.
In this trial the researchers quickly found that at higher dosages, some patients experienced too much inflammation, resulting in seizures, cognitive disturbances and other adverse events, so the amount infused was reduced. All but 15 of the 61 patients enrolled in the study had one of the lower dosages.
The NEJM article reported results on all 61 poliovirus patients. The median overall survival was 12.5 months, compared to 11.3 months for a historical control group. Starting at two years after treatment, the survival rates in the two groups began to diverge. The rate of overall survival of poliovirus patients at 24 months was 21 percent, compared to 14 percent for the historical controls. At three years, the gap widened further, with a survival rate of 21 percent for poliovirus patients, compared to 4 percent in the control group.
As a result, the poliovirus therapy has been granted "breakthrough therapy" designation by the FDA.
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