Novartis pauses trials of experimental cell therapy after three deaths
The halt was implemented on August 24 after Novartis was notified of three cases of a severe, life-threatening immune reaction. Complications from the reaction, in which the body's defense system overreacts and attacks its own organs, led to the deaths, the Swiss drugmaker said.
Novartis has suspended eight clinical trials of its experimental cell therapy, rap-cel, following the deaths of three patients. The suspension came on August 24 after the Swiss drugmaker received notification of three severe, life-threatening immune reactions. The immune reactions, marked by the body's defense system attacking its own organs, ultimately resulted in the three deaths.
Novartis halted the trials, which targeted autoimmune and neurological disorders, amidst a comprehensive review of the safety events. The company is collaborating with independent safety boards to investigate the incidents and identify measures to detect dangerous side effects earlier. While the trials assessing lymphoma and leukemia were unaffected, the therapy, a type of CAR-T therapy, is known to carry a potentially fatal risk of such severe immune reactions.
Novartis is actively sharing information with health authorities and continues to monitor patients who have received the treatment. The halted trials encompass conditions like lupus, rheumatoid arthritis, vasculitis, multiple sclerosis, and myasthenia gravis. Rap-cel modifies a patient's immune cells to recognize and destroy specific target cells, typically used to treat blood cancers but now being explored for other conditions.
Novartis' shares rose 4 percent on Tuesday, with investors focusing on the late-stage success of its oral multiple sclerosis drug, remibrutinib. The Wall Street Journal initially reported the halt, adding that US drugmaker Bristol Myers had also paused similar CAR-T trials in autoimmune disorders as a precautionary measure.
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