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Phase IIb Study of Vanoxerine Shows Strong Safety and Statistically Significant Efficacy Signals for Treatment of Atrial Fibrillation
Date:11/18/2013

ing and mirror what we saw in preclinical studies. If this clean safety record continues in the presence of this high degree of efficacy, vanoxerine could make a real difference in the care of the millions of people afflicted by AF."

Patients participating in the trial were measured for conversion from atrial fibrillation or flutter to normal sinus rhythm. Overall, there was a highly statistically significant dose-dependent increase in the conversion to normal sinus rhythm (P-value for all doses = 0.0005) compared to placebo. The highest oral dose (400 mg) achieved a conversion rate of 76 percent at 8 hours and 84 percent within the first 24 hours, a rate approaching that of direct current (DC) cardioversion. Patients taking placebo achieved a 25 percent conversion rate at 8 hours and a 38 percent conversion rate at 24 hours.

"Not only has vanoxerine demonstrated very promising safety data, it has statistically significant efficacy signals overall and in the two highest doses tested," said Howard Dittrich, Chief Medical Officer for ChanRx. "The efficacy data, coupled with a remarkable safety profile in this phase II study, bodes well for the next phase of vanoxerine's clinical development."

About Atrial Fibrillation
According to the National Institutes of Health, atrial fibrillation (AF) is the most common type of heart arrhythmia. AF can increase the risk of stroke and can also cause chest pain or heart failure. Treatments for atrial fibrillation include drugs to prevent blood clot formation and drugs that slow down heart rate. Options to control the rhythm of the heart are limited, with DC cardioversion, a non-pharmacological option, being the most common. DC cardioversion is highly effective, but it is a costly, resource-intensive procedure that requires anesthesia and follow up observation. Drug options to control the rhythm of the heart are limited primarily due to toxicity or because they cannot be used wi
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