Cardiome says 300 mg oral RSD1235 well-tolerated in target population

By Elaine Rigoli

Tampa, Fla., July 24 - Cardiome Pharma Corp. said interim clinical results from the 300 mg dosing group for its phase 2a pilot study of RSD1235 (oral) suggests that RSD1235 appears well-tolerated within the target population.

The interim analysis further demonstrated a clear positive trend toward efficacy, with 61% (33 of 54) of patients receiving RSD1235 completing the study in normal heart rhythm, as compared to 37% (10 of 27) of patients receiving a placebo.

A total of 83 patients were successfully cardioverted after the initial three days of dosing and continued in the study, of which 81 reached an endpoint of the study (completion of dosing or relapse to atrial fibrillation).

The remainder of the patients were discontinued from the study for reasons unrelated to atrial fibrillation, the company said in a news release.

During the 28 days of oral dosing, serious adverse events occurred in 9% of the placebo patients and 10% of the patients receiving RSD1235. Potentially drug-related serious adverse events occurred in 3% of placebo patients and 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 some current anti-arrhythmic drugs, the release said.

Enrollment and dosing for the second stage of this study, evaluating patients receiving a 600 mg dose of RSD1235 or a placebo twice per day, has now been completed. Results from this dosing group, and the complete study, are expected later in the third quarter of this year, the release said.

The company said it will start a larger phase 2b clinical study after an analysis of the phase 2a final results.

Cardiome is a cardiovascular drug-development company based in Vancouver, B.C.

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