SAN MATEO, Calif., Jan. 8 /PRNewswire/ -- Corthera Inc. today announced the initiation of 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.
Relaxin is a naturally occurring peptide hormone that acts as a targeted vasodilator with demonstrated systemic and renal hemodynamic effects. Elevated levels of Relaxin are thought to modulate increases in renal and cardiac function that meet the increased hemodynamic demands of pregnancy. Consistent with this natural role of the hormone, pharmaceutically manufactured Relaxin has been shown to have these effects in multiple human studies of men and non- pregnant women. Data from a pilot study in patients with heart failure support the expectation that these effects can be beneficial in relieving the signs and symptoms of heart failure.
Corthera Inc. is a biopharmaceutical company committed to acquiring,
developing and commercializing therapies for illnesses in the acute care
setting. Corthera's lead product candidate, Relaxin, is currently being
evaluated in clinical trials for acute heart failure and preeclampsia.
Corthera has worldwide rights to develop and commercialize Relaxin.
Contact: Timothy Engel or David Schull
|SOURCE Corthera Inc.|
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