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Cardiome And Astellas Announce Positive Results From ACT 2 Trial
NASDAQ: CRME TSX: COM
VANCOUVER and DEERFIELD, IL, June 4 /CNW/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") today announced results from their recently completed Phase 3 clinical study, called ACT 2. The trial evaluated the efficacy and safety of the intravenous formulation of vernakalant hydrochloride ("vernakalant (iv)") for the treatment of patients who developed atrial fibrillation or atrial flutter between 24 hours and 7 days following coronary artery bypass graft (CABG) or valve replacement surgery. In the atrial fibrillation population, 47% of patients dosed with vernakalant (iv) experienced conversion to normal heart rhythm within 90 minutes, as compared to 14% of placebo patients, a statistically significant difference (p=0.0001).
The ACT 2 study data suggests that vernakalant (iv) was well-tolerated in the studied patient population. In the 30-day interval following drug administration, serious adverse events occurred in 9% of all patients dosed with vernakalant (iv) and 11% of all placebo patients. Potentially drug-related serious adverse events occurred in 2% of patients who received vernakalant (iv) and 0% of placebo patients. There were no cases of drug-related "Torsades de Pointes", a specific and well-characterized ventricular arrhythmia.
The study achieved its primary endpoint in the combined atrial fibrillation and atrial flutter groups, showing that 45% of patients receiving vernakalant (iv) converted to normal heart rhythm within 90 minutes, as compared to 15% of placebo patients within the same time period (p=0.0002). Of the 10 patients in the atrial flutter population, no patients in the drug group and one patient in the placebo group converted to normal heart rhythm. A total of 190 patients were randomized in the study, of which 161 received treatment.
In the patients treated with vernakalant (iv) who converted to normal heart rhythm within 90 minutes, the median time to conversion was 12 minutes from the initiation of dosing.
"We are delighted to see a 47% conversion rate in post-operative atrial fibrillation patients, and in particular we are encouraged by the safety profile observed in this fragile patient population," stated Bob Rieder, Chief Executive Officer and Chairman of Cardiome. "The efficacy and safety results observed in this study are consistent with those we've seen throughout the vernakalant (iv) development program."
The ACT 2 study was conducted in 42 centres in the United States, Canada, Argentina, India and Europe. The study was focused on the treatment of patients with atrial fibrillation or atrial flutter occurring after CABG or valve replacement surgery. Approximately 30% of these patients have an episode of atrial arrhythmia following their surgery. The arrhythmia, though transient, is a significant medical concern.
"We are very pleased with the results of the ACT 2 trial and the important insight it provides about the use of vernakalant (iv)," stated Yoshihiko Hatanaka, President and Chief Executive Officer of Astellas Pharma US, Inc.
In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive license to develop and commercialize vernakalant (iv) in North America. The companies have co-developed vernakalant (iv) to NDA, with Astellas responsible for 75% of development costs. Cardiome has retained all rights to the intravenous formulations outside of Canada, U.S. and Mexico.
Cardiome will hold a conference call and webcast on Monday, June 4, 2007 at 9:00am EDT (6:00am PDT). Please dial 416-340-8010 or 866-540-8136 to access the call. There will be a separate dial-in line for analysts on which we will respond to questions at the end of the presentation. The webcast can be accessed through Cardiome's website at cardiome.com. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through July 4, 2007. Please dial 416-695-5800 or 800-408-3053 and enter code 3225539 followed by the number sign to access the replay.
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