The FDA designates certain treatments in development as breakthrough therapies. To achieve said designation, clinical evidence must suggest that a drug demonstrates the potential for substantial improvement over existing therapies. The FDA expedites the development and review process for breakthrough therapies.
The new cancer treatment is the brainchild of Matthais Gromeier, MD, microbiologist at Duke University in Durham, N.C. At Duke, Dr. Gromeier removed a key genetic sequence from the polio virus and replaced it with a benign cold virus sequence. The modification prohibits the viral disease from reproducing in normal cells, eliminating its ability to cause paralysis and death. However, the virus can reproduce in cancer cells. In this replication process, polio poisons cancer and then the human immune system does the rest.
“All human cancers, they develop a shield or shroud of protective measures that make them invisible to the immune system…this is precisely what we try to reverse with our virus. So by infecting the tumor, we are actually removing this protective shield. And enabling the immune system to come in and attack,” Dr. Gromeier told CBS News’ Scott Pelley.
Stephanie Lipscomb was the first volunteer for the trial that inspired the FDA to fast track the new treatment’s development. Ms. Lipscomb was a 20-year old nursing student when she was diagnosed with cancer in 2011. After having 98 percent of a brain tumor the size of a tennis ball removed, physicians told her the cancer returned in 2012. Ms. Lipscomb received the experimental treatment. Over a 21-month span, the tumor shrank and then dissipated completely. A 2014 MRI displayed no active cancer cells whatsoever.
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