Dr. Mallika Marshall from CBS station WBZ-TV in Boston reports for The Saturday Early Show on one woman who is trying Advexin in combination with chemotherapy in her own battle with breast cancer.
The therapy called Advexin uses the P-53 gene, a tumor suppressor, as a drug. It's injected directly into the tumor on a regular basis. With chemotherapy, Advexin adds up to a medical one-two punch.
The company that produces Advexin expects to finish with the third trial stage by the end of next year. Shortly afterwards, they will file an application with the Food & Drug Administration, seeking to make the drug more widely available. When they file the application, they will ask for something commonly known as "fast track approval," which can get the drug out more quickly.
So far, there hasn't been any major controversy surrounding Advexin. While it is gene therapy, it's not the gene therapy we are so used to hearing about. The kind of gene therapy that generates controversy is when scientists try to repair or replace genes. With Advexin, doctors are using the P-53 gene, which is already in the body, as a drug.
Researchers don't anticipate always using Advexin in conjunction with chemotherapy. It will depend on the patient. Some will require chemotherapy; others will use only Advexin.