Aggregated News
A Phase 1 trial testing a Poseida Therapeutics cell therapy in men with prostate cancer is on hold after a patient enrolled in the study died of liver failure nearly three weeks after receiving the treatment.
The San Diego company, which has touted its product candidates as safer than early-generation versions developed by other companies, announced the FDA’s decision to pause the study on Monday.
Poseida (NASDAQ: PSTX) is evaluating P-PSMA-101, a chimeric antigen receptor T-cell (CAR-T) therapy, in patients with prostate cancer that has spread beyond its initial location and stopped responding to drugs intended to lower levels of the male sex hormones that drive the cancer. The treatment is an autologous one—created from a patients’ own immune cells, which are engineered in a laboratory to better fight cancer before being reinfused.
The patient who died in the trial received P-PSMA-101 in late July following prior treatment with multiple cancer drugs, according to a regulatory filing. Poseida, in the filing, said there were no side effects in the first seven days after treatment. But subsequently, symptoms arose...