Brain Cancer Therapy Receives Breakthrough Status
The work toward curing, or at least effectively treating, a form of brain cancer has made significant strides over the past few years with the help of researchers at Duke University. Subsequent to the findings of the Phase I Clinical Trials, the FDA has changed the status of the trial to that of a breakthrough therapy.
Breakthrough Therapy Designation
The Breakthrough Therapy Designation came into being with the signing of the FDA Safety and Innovation Act in 2012. This designation requires that the drug treat a life threatening condition or disease, and that evidence indicates it is a significant improvement over current treatment options. The designation allows the FDA to expedite drug development.
The designation does not mean the drug has been approved for clinical use. However, it does allow the researchers to utilize the resources of the FDA to develop more efficient clinical trials and better evaluate the efficacy and safety of the treatment.
Genetically Engineered Poliovirus
The treatment developed at Duke University relies on a genetically engineered Poliovirus (PVS-RIPO). The virus is designed to attack and kill the cancer cells while not damaging healthy cells. To do this, the genetic code that allowed the poliovirus to cause disease was removed, and replaced with the genetic code of a rhinovirus. PVS-RIPO is able to to infect most cancer cells because the receptor used for entering the cell, found in the poliovirus, is present in most cancer cells. The ability of PVS-RIPO to grow and kill cells is dependent upon biochemical abnormalities found only in cancer cells.
PVS-RIPO is injected directly into the brain tumor in order to ensure a maximum payload of the virus to the tumor. PVS-RIPO then infects and kills the tumor, but it also incites the patient’s immunological response to attack the virus infected tumor as well. The eventual hope for the therapy is that it will be extended to treat other types of cancers.
CBS has been following the trials for more than a year. They recently reported that one of the patients, Stephanie Lipscomb, now shows no evidence of active cancer cells. While researchers and media are hesitant to call the treatment a cure, it is certainly one of the most promising cancer therapies currently in production.
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