Nortran Pharmaceuticals Inc has begun a Phase 1 clinical trial for RSD1235, its candidate for treatment of acute atrial fibrillation. Initial dosing of volunteers took place.

The Phase 1 study will investigate the safety of RSD1235 in humans. The study is a randomized, placebo-controlled, ascending dose tolerance study in healthy volunteers. The trial will include 38 male and female volunteers, each of whom will receive one of up to nine doses to be tested. The study will also assess drug pharmacokinetics.

"This trial will assess the safety and pharmacokinetics of RSD1235 in humans. Safety is the primary reason that many current antiarrhythmic drugs are not prescribed. This study will therefore address one of the most critical issues in antiarrhythmic drug development," said Dr. Alan Ezrin, Nortran's Chief Scientific Officer. "The study will also give an indication of the appropriate dose range to use for patients in the Phase 2 clinical trial."

Atrial arrhythmia consists of rapid and ineffective beating of the atria, or storage chambers, of the heart. This type of an arrhythmia is not directly life threatening, but causes increased risk of stroke, because the stagnant blood, which is pooled in the arrhythmic atria, can lead to blood clotting. Approximately 7.2 million people in the developed world suffer occasionally or chronically from such atrial arrhythmias. Several different drugs are currently used to treat atrial arrhythmia, but all have serious - in some cases, life threatening - side effects. The market for all prescribed antiarrhythmic drugs totalled $1.3 billion in 1999. Of this amount, $1.0 billion was prescribed for atrial arrhythmia. The estimated unmet market for a safe and effective atrial antiarrhythmic therapy is approximately $1.7 billion suggesting a total market opportunity of $2.7 billion.

The U.S. Food and Drug Administration has reviewed the study protocol and has approved commencement of the Phase 1 clinical trial. Nortran had previously submitted an Investigational New Drug (IND) application to the FDA"