Cancer drug developer Curis now has FDA approval to resume one of two clinical trials suspended in the spring after a patient died. Coolis said Thursday that the FDA Lifting some clinical hold He was involved in an early-stage lymphoma study after the company came up with a plan to address potentially fatal complications.
So far, that status has remained the same as a separate part shelved a study testing the same Curis drug, emavusertib, in leukemia. The reported death occurred in this Phase 1/2a study, leading the FDA to suspend the trial on April 4At the time, Lexington, Massachusetts-based Curis also voluntarily suspended a Phase 1/2 study testing the drug in lymphoma as a precaution. The FDA also partially put the trial on hold the following week. Both partial reservations allow currently enrolled patients to continue receiving the experimental drug, but prohibit enrollment of any new patients.
The deceased patient experienced a dose-limiting side effect called rhabdomyolysis, Coolis said in April. This complication is characterized by the death of muscle tissue, which releases muscle fibers and other substances into the bloodstream that can damage organs such as the heart and kidneys. Rhabdomyolysis is a known complication of Curis’ drug, a small molecule designed to block IRAK4, part of a pathway that is often dysregulated in cancer patients.
In announcing the partial lift of the lymphoma study, Curis did not disclose any other details about the deaths of patients in the leukemia study. But the biotech said that after reviewing a comprehensive data package submitted by the company, the FDA has agreed to Curis’ strategy to identify and manage rhabdomyolysis in the lymphoma study, which is designed to test a 300-mg dose of emavusertib twice daily. As part of the agreement with the FDA, the company will also enroll at least nine additional patients at the 200-mg dose level, Curis said.
CEO James Dentzer said in a prepared statement that Curis is working with clinical trial sites to resume recruiting new lymphoma patients in the third quarter. The company now expects to have clinical data from the study in 2023.
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