Corthera Initiates Clinical Trial Of Relaxin In Acute Heart Failure
Corthera initiates patient enrollment in a Phase II clinical trial of Relaxin, a naturally occurring peptide hormone that is being developed for acute heart failure and other acute care illnesses.
The trial will investigate the efficacy and safety of Relaxin in patients with acute heart failure. Approximately 330 patients will be recruited from more than 50 investigational centers worldwide. The primary outcome measure is the improvement of clinical signs and symptoms of acute heart failure, with additional secondary outcome measures, including improvement in renal function.
"With the current lack of safe and effective therapies for acute heart failure, we are very pleased to advance the development of Relaxin for the benefit of these patients," said Stan E. Abel, president and chief executive officer of Corthera. "The clinical and preclinical results to date are very encouraging, demonstrating Relaxin's beneficial hemodynamic properties."
According to the American Heart Association, heart failure is a costly cardiac and renal syndrome affecting more than 550,000 new patients per year, with projected direct and indirect costs at $33.2 billion in 2007. Acute heart failure is characterized by fluid overload (congestion), especially in the lungs, that causes shortness of breath and other complications. The current standard of care includes diuretics and vasodilators. Diuretics, which promote fluid excretion, are associated with renal complications. Vasodilators tested to date have been linked to hypotension, renal impairment and adverse outcomes.