After a few patient deaths, a clinical trial of immunotherapy has been put on hold, at the direction of the FDA.
Immunotherapy is heralded as the new frontier in the war on cancer. It works by harnessing the body’s immune system fight the cancer from within. But many of these cutting-edge treatments are still in the experimentation phase. A Phase II clinical trial is designed to test the effectiveness of a new drug or treatment. It typically follows a Phase I trial, which evaluates safety and side effects. Before a new drug or treatment goes to market, it must also pass through a Phase III trial, as outlined by the National Institutes of Health.
In a conference call with reporters on Thursday, Juno CEO Hans Bishop revealed that the two patients, along with an additional patient in May, died as the result of cerebral edema — brain swelling caused by the presence of excessive fluid. Investigators, he said, pinpointed the likely culprit to be the addition of fludarabine to the pre-conditioning regimen, a one-time primer for treatment. In this particular course of treatment, pre-conditioning consists of a heavy dose of chemotherapy to kill off existing cancer cells in order to give the new, cancer-killing T-cells room to grow. It’s like hitting a reset button to restart the immune system.
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