Juno trials on hold after the death of other two patients

by Jared Lewis July 10, 2016, 11:23
Juno trials on hold after the death of other two patients

The three deaths were caused by cerebral edema (which is a build up of fluid in the brain). According to the company, the setback would mean that the initial treatment would not be introduced in market by the end of 2017, which they were expecting. Regulators have said they'll review that information quickly, but it's anyone's guess when such a review could result in a lifting of the clinical hold that's been placed on this trial. He says the fatalities did not occur in NY but at other centers participating in the trial.

The drug trial is for a treatment known as chimeric antigen receptor T-cell (CART). In response, the FDA has asked us to submit 4 specific documents in complete response to the clinical hold. "The patients who died in the Rocket trial got fludarabine and cyclophosphamide as preconditioning drugs to deplete certain blood cells, and create what scientists think is a more favorable environment for re-infused T-cells to engraft and start attacking cancer".

In simple terms, it works by removing t cells from a patient and then re-engineering them to fight cancer. A separate patient, who was given fludarabine as a pre-conditioning therapy, died back in May. It is noted that the three patients were also administered an established chemotherapy drug called fludarabine and it is possible that the deaths related to the use of the established drug. The first death was seen in May, although the cause of this event could not be determined.

Immunotherapy is heralded as the new frontier in the war on cancer. The Juno trial chose to add the drug to the chemotherapy sessions. As these super-charged T-cells reproduce and spread throughout the body, they identify, bind to, and destroy the cancerous cells.

Indeed, Juno executives said Thursday the people in the CART trials had exhausted all other avenues of treatment.

In their report, they also highlighted a risk of read-through to Kite Pharma, which is developing a auto T platform of its own, although they see some fundamental differences between the two companies. "If the FDA is satisfied with the materials and lifts the clinical hold, we will continue the trial with the aim to make JCAR015 broadly available to adult patients with relapsed or refractory ALL", said Bishop.

The trial's share price has downgraded since the death were announced, nearly in a 30 percent at the first hours of the announcement.

They added they plan to still use fludarabine in other types of CART studies where the drug has not produced any serious side effects.

Juno still has a number of other CAR-T therapies in its pipeline, treating various forms of blood cancer. "Juno Therapeutics stopped its phase 2 "ROCKET" trial for JCAR015 under instruction from the FDA after the two recent deaths, which follow another earlier this year - though the company hopes to restart the trial after making changes to how the drug is delivered", according to a recent UPI News report.


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