Oct 23 (Reuters) – Bristol Myers Squibb on Friday disclosed a patient death in an early-stage trial studying its experimental CAR-T cell therapy.
Shares of the drugmaker were trading 2% lower in early trading.
The company said a patient with highly active relapsing multiple sclerosis, a central nervous system autoimmune condition, died of septic pneumonia.
The patient was a participant in the trial of Bristol Myers’ experimental cell therapy zolacabtagene autoleucel, or zola-cel, that is designed to target CD19, a protein found on certain cells that are believed to play a role in autoimmune diseases.
After receiving a high-dose of a type of chemotherapy, the patient developed septic pneumonia and died the next day, 44 days after the CAR-T infusion. The patient had delayed motor symptoms that did not respond to treatment with corticosteroids or intravenous immunoglobulin.
In September, the company said it was implementing a voluntary pause on studies for zola-cel, “out of an abundance of caution” as it reviews safety data, after Novartis paused eight clinical trials of an experimental cell therapy, called rap-cel.
Bristol’s early-stage trial enrolled 66 patients, 30 of whom had highly active relapsing MS, and the rest had progressive forms of the disease.
In MS, the immune system attacks the protective sheath that covers nerve fibers, known as myelin, which interrupts communication between the brain and the rest of the body.
The company said majority of the side effects were brief and reversible, generally consistent with the previously reported zola-cel data.
In the study, 42.4% of patients had cytokine release syndrome events, a systemic inflammatory response triggered by an overactivation of the immune system.
Five patients experienced immune effector cell-associated neurotoxicity syndrome, a neurological disorder caused by inflammation, but was resolved in about two days.
A patient with a progressive form of MS experienced a severe form of the neurotoxicity event, which was treated and resolved within four days.
No additional severe side effects have been reported across all zola-cel programs in autoimmune diseases, which include 190 patients treated in early studies, the company said.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shinjini Ganguli)
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