FDA GRANTS BREAKTHROUGH STATUS TO DUKE UNIVERSITY CANCER TREATMENT DOCUMENTED BY “60 MINUTES” SUNDAY ON CBS
Promising Breakthrough Therapy Uses the Poliovirus to Battle Cancer Tumors
The Food and Drug Administration has granted breakthrough status to a cancer therapy that has used the polio virus to successfully battle brain tumors. 60 MINUTES has tracked critically ill patients in the phase-one clinical trial for the therapy pioneered by Duke University for two years. 15 of the 23 patients suffering from glioblastoma-- a nearly always fatal brain cancer – who were treated with the clinical trial’s optimal dose are still alive. This new status from the FDA will fast-track the promising treatment so hundreds of cancer patients can access it at approximately 40 separate institutions around the world. Scott Pelley’s report will be broadcast on 60 MINUTES, Sunday May 15 (7:00-8:00 PM, ET/PT) on the CBS Television Network. An excerpt of that report appears tonight, Friday, May 12 (6:30-7:00 PM, ET/PT) on the CBS EVENING NEWS WITH SCOTT PELLEY.
In this excerpt, Stephanie Lipscomb tells Pelley how she came to be patient number one at the age of 20 in the breakthrough clinical trial. She has been cancer free now for over two years. Lipscomb, a nurse, says she is going back to school to become a pediatric oncology nurse.
EVENING NEWS EXCERPT – PLEASE CREDIT 60 MINUTES:
PELLEY NARRATION: It's a hell of a thing to be told that you have months to live when you're 20 years old. In 2011, Stephanie Lipscomb was a nursing student with headaches. A doctor told her she had this glioblastoma tumor the size of a tennis ball.
PELLEY: You had 98% of the tumor removed.
PELLEY: As much radiation as you can have in a lifetime. And chemotherapy.
PELLEY: And then in 2012, what did the doctors tell you?
LIPSCOMB: Your cancer's back. With recurrent glioblastoma there were no options except the one that had never been tried, Stephanie became the first volunteer for duke's experiment with the polio virus.
NATS: The virus is the creation of molecular biologist Matthias Gromeier. Gromeier re-engineered the virus, removing a key genetic sequence. The virus can't survive this way so he repaired the damage with a harmless bit of cold virus. This new modified polio virus can't cause paralysis or death because it can't reproduce in normal cells. But in cancer cells it does and in the process of replicating it releases toxins that poison the cell. This also awakens the immune system to the cancer it never noticed before.
PELLEY: Why didn't the immune system react to the cancer to begin with?
GROMEIER: So cancers-- all human cancers, they develop a shield or shroud of protective measures that-- make them invisible to the immune system. And this is precisely what we try to reverse with our virus. So by infecting the tumor, we are actually removing this protective shield. And telling the enabling the immune system to come in and attack.
It appears the polio starts the killing but the immune system does most of the damage. Stephanie Lipscomb's tumor shrank for 21 months until it was gone. Three years after the infusion something unimaginable had happened. This is from an MRI in August, 2014.
PELLEY: And there's no cancer in this picture at all-
DESJARDINS: And we don't see any cancer, active cancer cells.
PELLEY NARRATION: As is typical, Duke started a company to attract research dollars to the therapy, Gromeier is an investor. The FDA granted breakthrough status after data showed patients who were living 10 months were now living 15 and three patients are cancer free after three years. See the full story this Sunday on 60 MINUTES.
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Kevin Tedesco 212 975-2329 email@example.com