Prescient Therapeutics Ltd. placed the phase 1b breast cancer trial of its lead drug PTX-200 on hold after reporting a fatality.
The trial, which enrolled 29 patients, was evaluating PTX-200 in combination with chemotherapy drug paclitaxel. The Australian company said the patient, suffering from stage 4 metastatic triple negative breast cancer, experienced hepatic or liver failure during treatment with the medication.
The principal investigator of the trial believes the death could be related to PTX-200, paclitaxel or pioglitazone, a diabetes drug.
Prescient said it temporarily paused recruitment to all PTX-200 trials to further investigate the death and notified the U.S. Food and Drug Administration, which put the trial on clinical hold.
The patient death would appear as a blow to the company, given that PTX-200 was scheduled to move into phase 2 study.