Juno Therapeutics Ordered To Stop Experiments Of New Leukemia Treatment After Two Deaths

After two patient deaths, the government terminated an experimental treatment for leukemia. The technique, created by Juno Therapeutics, involves training cells to attack the disease.

Earlier this week, the Food and Drug Administration stopped the trial after Juno reported two patients died from swelling of the brain.

BREAKING: Juno Therapeutics, pioneer in treating cancer by revving immune system, halts trial after 3 patient deaths https://t.co/3zIR1IsGzF

— STAT (@statnews) July 7, 2016

“This is a humbling experience,” said Hans Bishop, Juno’s CEO. “No doubt it is difficult for the physicians who are looking after these patients and their families. 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.”

During a Thursday conference call, company executives said the FDA concluded a previous death of a patient in May was due to “compounding factors.” The company said the two recent deaths were not caused by the new therapy, but by the addition of a second chemotherapy drug, fludarabine. With the approval of the FDA, Juno intends to continue the study without the drug.

The first experiments involved only one chemotherapy drug designed to prepare the immune system for the experimental therapy. However, once the treatment was supplemented with fludarabine, doctors saw in a jump in “severe neurotoxicity.”

Setbacks are simply part of the research process when developing a new treatment and proceeding with caution makes sense.

“This sort of thing is incredibly common in new drug development. It’s unfortunate, but I don’t know how you avoid it,” said Dr. Otis Brawley, chief medical officer for the American Cancer Society.

Brawley said linking the deaths directly to fludarabin is actually good for the trial.

“That actually helps them a little bit. And hopefully they can get this back on track,” he said.

The experimental therapy developed by Juno is known as chimeric antigen receptor T-cell, or CART. The method genetically engineers a person’s T-cells, a form of white blood cells, so they will seek out and destroy B-cells. These B-cells sometimes become malignant in several types of blood cancer.

The process involves the patient taking a concoction that destroys existing T-cells, making it easier for the genetically modified T-cells to take over. Some experiments revealed the addition of fludarabine to the therapy helps the cells grow faster.

With room for 90 participants, approximately 20 patients are currently involved in the trials. Of those, only a few of them got a dose of fludarabine. The three patients who died did receive the second chemo drug.

To continue the experiments, Juno must send updated documents to the FDA. The agency must review and approve the company’s new testing protocols, patient disclosure forms as well as other features of the trial. While a standard review takes 30 days, the FDA plans to expedite the evaluation process.

Once the trial continues, Juno will only treat patients with a drug called cytoxan, the same drug used in previous experiments. However, the company intends to keep using fludarabin in other CART treatments.

Conducting a similar trial funded by Novartis, Dr. Stephan Grupp, Novotny Professor of Pediatrics at the University of Pennsylvania Perelman School of Medicine, said none of his patients experienced brain swelling even after the addition of fludarabine. Confusion, aphasia, and seizures were the only side effects reported, all of which were resolved, he noted.

Juno Therapeutics down 30% after FDA puts clinical trial on hold #immunotherapy #leukemia https://t.co/0OU4TCF5Gc http://pic.twitter.com/rfVwfc0IJI

— WLST.com (@wlstcom) July 7, 2016

At the end of business Friday, Juno shares closed at $27.81, a 30 percent drop. Shares of the company are down nearly 40 percent over the past year.

Juno Therapeutics is working on several other gene-modifying therapies for leukemia and may get its first approval sometime in 2018. In addition to Juno and Novartis, Kite Pharma is also working on a similar treatment for the disease.

[Photo by Justin Sullivan/Getty Images]

Juno Therapeutics Ordered To Stop Experiments Of New Leukemia Treatment After Two Deaths is an article from: The Inquisitr News