Cardiome’s pivotal cardio study achieves primary endpoint

ACT 1 measured the safety and efficacy of intravenous RSD1235 in 416 patients with atrial arrhythmia. The primary endpoint in ACT 1 was conversion of recent-onset AF to normal heart rhythm for a period of at least one minute post-dosing within 90 minutes of the start of dosing.

In the overall atrial fibrillation (AF) study population, 38% of patients who were dosed with RSD1235 experienced termination of AF, as compared to three percent of placebo patients. In the longer-term AF population, eight percent of patients who were dosed with RSD1235 had their AF terminated, as compared to zero percent of placebo patients.

In the recent-onset AF population, 52% of those who were dosed with RSD1235 experienced conversion to normal heart rhythm, as compared to four percent of placebo patients.

The ACT 1 study data suggests that RSD1235 is also safe and well-tolerated in the targeted patient population. In the 30 day interval following drug administration, serious adverse events occurred in 18% of placebo patients and 13% of drug group patients. Potentially drug-related serious adverse events occurred in zero percent of placebo patients and 1.4% of patients receiving RSD1235.

There were no cases of drug-related “Torsades de Pointes”, a well-characterized arrhythmia which is an occasional side effect of many current anti-arrhythmia drugs.

“We are excited about the clear and decisive results shown in this important study of RSD 1235,” stated Bob Rieder, president and CEO of Cardiome. The company expects to disclose additional data from the study in January 2005, with full study details to be presented in May 2005.