Biotechnology Startup's Trial of Cancer-Killing Cells Results in 3 Patient Deaths; Study Halted as Stock Dips
Juno Therapeutics, a Seattle-based biotechnology startup, is in trouble after its closely monitored clinical trial of cancer-killing cells resulted to the death of three patients. The U.S. Food and Drug Administration (FDA) has ordered the 4-billion-dollar company to temporarily halt the promising study that was once expected to produce a breakthrough product.
In a statement released on Thursday, Juno Therapeutics announced that it will be putting a hold on a phase 2 clinical trial called "ROCKET" in compliance with the FDA's order. The notice to temporarily halt the biotechnology startup's heavily funded clinical trial came after three patients died during the process.
Juno Therapeutics' clinical study used genetically engineered white blood cells (called T-cells) from the leukemia patients to kill their malignant B cells. More than 20 adult patients with relapsed or refractory B cell acute lymphoblastic leukemia were involved in the biotechnology startup's clinical study.
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The complicated technique used by Juno Therapeutics attracted media attention because it is daring and promising. It was anticipated to be a major breakthrough as it appeared to cure cancer or temporarily make it disappear.
Failure of Juno Therapeutics' Clinical Trial
Juno Therapeutics explained that the death of three leukemia patients occurred after it added a chemotherapy drug called fludarabine on its preconditioning treatment. All three patients who died in the trial suffered from swelling in the brains due to excess fluids. The company said that there were at least 10 patients who received fludarabine.
Hans Bishop, chief executive officer of Juno Therapeutics, told Forbes that the death of the three patients is a humbling experience. "Clearly these therapies are potent, that's why they offer the potential for cures. We're still learning to use them in the safest, most efficacious way," Bishop reasoned out.
Juno Therapeutics' Stock Plunged
After Juno Therapeutics announced that it halted its trial of cancer-killing cells, its shares plunged to almost 30 percent, according to Bloomberg. The stocks of drug companies offering similar products have also plummeted.
Despite the deaths of three patients, it is not yet an end for Juno Therapeutics' clinical trial on cancer-killing cells. The biotechnology startup has appealed to the FDA to continue the clinical trials without the use of fludarabine.
In response, the FDA has required Juno Therapeutics to submit a complete response to the clinical hold, including revisions on some of its documents. The biotechnology startup is planning to immediately comply with the FDA's requirements this week.
