The U.S. Food and Drug Administration placed a hold on a Juno Therapeutics clinical trial of a treatment for a form of leukemia following the death of two trial patients last week.
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After Juno Therapeutics announced that it halted its trial of cancer-killing cells, its shares plunged to nearly 30 percent, according to Bloomberg.
This particular CART treatment, known as JCAR015, was expected to be Juno’s first product on the market, according to a Forbes article.
The company has submitted data to the FDA supporting this hypothesis, and expects to continue the trial once the issue is confirmed by the agency.
Two top executives and dozens of other employees of Juno Therapeutics, the company that on Thursday was forced to halt a clinical trial after three leukemia patients died, are alumni of another biotech company that declared bankruptcy two years ago after disappointing sales of its one product. In Juno’s trial, patients were given a number of chemotherapy drugs before initiating the CAR-T therapy to kill off a patient’s own T-cells.
The first death happened back in May. The company said that there were at least 10 patients who received fludarabine.
Trials of an experimental therapy to treat Leukemia have been halted by USA authorities after two patients died last week. About Juno Juno Therapeutics is building a fully integrated biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer. In the clinical trial Juno has used only one chemotherapy drug- cyclophosphamide. All three patients who died in the trial suffered from swelling in the brains due to excess fluids.
In simple terms, it works by removing t cells from a patient and then re-engineering them to fight cancer.
Juno said it believed the deaths, the result of brain swelling, were caused by a preconditioning treatment, fludarabine, not by the T cells themselves. In fact, investigation into fludarabine was almost halted altogether for patients with leukemia, following the development of delayed central nervous system toxicity.
So what’s next? Well, if all is as Juno thinks it is, there should be no reason for the FDA to extend the hold beyond a small investigational period.
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In early stage clinical trials, CART therapies were found to eliminate all trace of lymphoma and leukemia in 40 percent to 90 percent of participants. “This disease is extremely hard to treat and progresses rapidly when it becomes refractory; most patients die within a few months”. Junos product candidates, JCAR015, JCAR017 and JCAR014, utilize auto technology to target CD19, a protein expressed on the surface of various B cell leukemias and lymphomas.
