Sept 1 (Reuters) – Novartis said on Tuesday it paused eight clinical trials of an experimental cell therapy, called rap-cel, targeting autoimmune and neurological disorders in late August, after three patients died.
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 is conducting “a comprehensive review of the observed safety events” and is working with independent safety boards to review what happened as well as to find ways to catch dangerous side effects earlier.
Novartis said its two trials in patients with lymphoma and leukemia were not affected by the halt.
The drugmaker said that this type of severe immune reaction is a known, potentially life-threatening risk of CAR-T therapy. Novartis added that it is actively sharing information with health authorities and will continue to monitor patients who have already received the treatment.
The trials affected include those for inflammatory diseases such as lupus, rheumatoid arthritis, and vasculitis and nerve- and muscle-weakening disorders including multiple sclerosis and myasthenia gravis.
Rap-cel is a type of CAR-T therapy which modifies a patient’s immune cells to recognise and destroy specific target cells. While traditionally used to treat blood cancers, drugmakers have been testing these therapies for autoimmune and other conditions.
Shares of the Swiss drugmaker were up 4% on Tuesday as investors focused on the late-stage success of its oral multiple sclerosis drug, remibrutinib.
The Wall Street Journal first reported the halt. The newspaper said U.S. drugmaker Bristol Myers had also paused similar trials of its CAR-T treatment in autoimmune disorders as a precautionary measure.
Bristol did not immediately respond to a Reuters request for comment outside of business hours.
(Reporting by Shivani Tanna in Bengaluru and Bhanvi Satija in London; Editing by Janane Venkatraman and Mrigank Dhaniwala)
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