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Corthera Initiates Phase II Clinical Trial Of Relaxin In Acute Heart Failure
Corthera Inc. 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.
About Relaxin
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.
About Corthera
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.
Corthera Inc.
http://www.basmedical.com
Faza a II-Corthera iniþiazã studiu clinic Din Relaxin În insuficienþã cardiacã acutã - Corthera Initiates Phase II Clinical Trial Of Relaxin In Acute Heart Failure - articole medicale engleza - startsanatate