Cardiome Pharma Shares Soar on Positive Results From Anti-Arrhythmic Drug Trial
NEW YORK -- Shares of Cardiome Pharma Corp. soared in premarket trading Monday after the cardiovascular treatment developer said its anti-arrhythmic heart medicine appears to be "well-tolerated" and safely normalized heart beats for many patients in a midstage clinical trial.
Shares soared $3.99, or about 45 percent, to $12.80 in premarket trading on the INET electronic exchange after closing the Nasdaq session at $8.91 on Friday.
The drug, called RSD1235, is being studied for its ability to prevent recurrence of atrial fibrillation, which is characterized by irregular heart beats, or arrhythmia.
The condition puts patients at a higher risk of stroke and impaired cardiac function and affects about 4 million people worldwide, Cardiome said.
Safety data from the Phase 2a pilot study, which began in December 2005, suggest that 300 mg oral doses of RSD1235 restored normal heart rhythms for 33 out of 54 patients, or 61 percent, involved in the study. That compares to 37 percent, or 10 out of 27 patients, who received placebo.
During the 28-day trial, serious adverse events occurred in 9 percent of placebo patients and 10 percent of the patients taking RSD1235.
Patients who suffered drug-related serious adverse events occurred in 3 percent of placebo patients and 4 percent of patients on the trial medication. There were no cases of a certain form of arrhythmia that is sometimes caused by other anti-arrhythmic drugs.
Results from a second phase of the study that is investigating a 600-mg dose of the drug is slated for release in the third quarter, Cardiome said.
NEW YORK -- Shares of Cardiome Pharma Corp. soared in premarket trading Monday after the cardiovascular treatment developer said its anti-arrhythmic heart medicine appears to be "well-tolerated" and safely normalized heart beats for many patients in a midstage clinical trial.
Shares soared $3.99, or about 45 percent, to $12.80 in premarket trading on the INET electronic exchange after closing the Nasdaq session at $8.91 on Friday.
The drug, called RSD1235, is being studied for its ability to prevent recurrence of atrial fibrillation, which is characterized by irregular heart beats, or arrhythmia.
The condition puts patients at a higher risk of stroke and impaired cardiac function and affects about 4 million people worldwide, Cardiome said.
Safety data from the Phase 2a pilot study, which began in December 2005, suggest that 300 mg oral doses of RSD1235 restored normal heart rhythms for 33 out of 54 patients, or 61 percent, involved in the study. That compares to 37 percent, or 10 out of 27 patients, who received placebo.
During the 28-day trial, serious adverse events occurred in 9 percent of placebo patients and 10 percent of the patients taking RSD1235.
Patients who suffered drug-related serious adverse events occurred in 3 percent of placebo patients and 4 percent of patients on the trial medication. There were no cases of a certain form of arrhythmia that is sometimes caused by other anti-arrhythmic drugs.
Results from a second phase of the study that is investigating a 600-mg dose of the drug is slated for release in the third quarter, Cardiome said.
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