Cardiome Announces Positive Interim Phase 2b Results for Oral Vernakalant and Engages Merrill Lynch as Strateg...(n (n537) whichincludes patients randomiz...),Health

Date:3/17/2008

n (n=537), which includes patients randomized who did not enter the maintenance phase of the study. During the dosing period under analysis, there was no difference in the incidence of serious adverse events between treatment groups. Potentially drug-related serious adverse events occurred in 1% of placebo patients, 2% of patients in the 150mg dosing group, 0% of patients in the 300mg dosing group and 1% of patients in the 500mg dosing group. 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. There were 2 deaths during this period, both unrelated to vernakalant (oral), comprising a patient in the 150mg dosing group who died of cervical cancer at day 79, and a patient in the placebo group who died at day 86 after suffering an ischemic stroke.

"Our strategic intent with this study was to pave the way to Phase 3 and provide efficacy and safety data to support business discussions," said Bob Rieder, Chairman and Chief Executive Officer of Cardiome. "This strong interim data set clearly enables us to move forward in planning the Phase 3 program and continue our discussions with interested parties."

The double-blind, placebo-controlled, randomized, dose-ranging study was designed to explore safety and tolerability, pharmacokinetics and efficacy of vernakalant (oral) over 90 days of dosing in patients at risk of recurrent atrial fibrillation. Patients received a 150mg, 300mg or 500mg dose of vernakalant (oral) or placebo twice per day. After the first 3 days, patients still in atrial fibrillation were electrically cardioverted. Successfully cardioverted patients continued to receive vernakalant (oral) or placebo for the remainder of the 90-day trial and were monitored throughout the dosing period.

Cardiome initiated the Phase 2b in the first quarter of 2007. Enrollment has completed, with a total of 735 patients randomized of which approxim
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SOURCE Cardiome Pharma Corp. Copyright©2008 PR Newswire. All rights reserved

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