Cardiome Pharma Corp.’s (TSX:COM) share price was down 14% at press time on Thursday morning after the company said its drug partner suspended patient enrollment in a clinical study following a “serious” event.
The Vancouver-based company said its co-development partner, Astellas Pharma US Inc., suspended enrollment in the ACT 5 study of KYNAPID after a patient who was injected with KYNAPID experienced cardiogenic shock.
According to the U.S. National Lung, Heart and Blood Institute, cardiogenic shock is caused when a weakened heart is unable to pump enough blood to the rest of the body and can be fatal if not treated right away. Cardiome did not say if the patient died.
The ACT 5 trial is a study to evaluate the safety and efficacy of the KYNAPID injection for patients with atrial fibrillation or abnormal heart rhythm.
Drug developer Cardiome said the study would enroll 470 patients across approximately 100 centres.
The trial’s independent Data Safety Monitoring Board (DSMB) has recommended the study continue, though the U.S. Food and Drug Administration (FDA) has requested full data regarding the case before it determines what steps need to be taken, if any, before the study is restarted.
“We and Astellas will work closely with the clinical trial site, the DSMB and the FDA to review this serious adverse event and resume patient enrollment and treatment in the ACT 5 study as soon as it is appropriate to do so,” Cardiome president and CEO Doug Janzen said in a statement.
The company could not be reached for comment.