by Julie Fidler, Natural Society:
U.S. regulators in July of 2016 halted a trial of Juno Therapeutics Inc.’s experimental cancer therapy, known as JCAR015, after three patients died.
JCAR015 uses genetically engineered cells as a treatment for cancer. However, one of the pursuits in oncology was temporarily halted by the FDA when some of the participants developed fatal swelling in the brain.
Hans Bishop, Juno’s chief executive, said in a conference call with securities analysts that the deaths were “difficult and humbling for everyone involved.”
As a result of the announcement, Juno stock fell 27% in after-hours trading.
Bishop and other Juno executives believe the catastrophic side effects were the result of the combination of the chemotherapy drug and the particular cells being used.
Juno has asked to continue the trial without the drug, but it’s not clear whether the FDA will agree, or when it will make a decision. Company executives said it could be within 30 days.
Juno is working on CAR-T therapy, which entails drawing blood from a patient to extract immune cells, which are then genetically engineered to make them kill cancer cells. These immune cells are then placed back into the bloodstream to do their work.
Early studies have shown promising results in certain types of leukemia and lymphoma.
However, severe side effects can occur, especially immune system overreactions and neurological toxicity, including cerebral edema, which is swelling in the brain. Several deaths have been caused by these adverse events.
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