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Corthera's Relaxin Receives FDA Fast Track Designation for the Treatment of Acute Heart Failure
Date:10/1/2009

romising safety and efficacy of relaxin seen in these patients. The Pre-RELAX-AHF / RELAX-AHF study was designed and conducted in collaboration with Momentum Research, headed by Dr. Gad Cotter, a noted heart failure expert.

"Patients with acute heart failure remain a major clinical challenge with very high morbidity and mortality rates and limited treatment options," said John R. Teerlink, M.D., Professor of Medicine, University of California San Francisco, Director of Heart Failure, Veterans Affairs Medical Center, San Francisco, and co-principal investigator of the studies. "The importance of this Fast Track designation is two-fold as it acknowledges a significant unmet medical need and recognizes relaxin's potential as an important treatment option for patients with AHF."

According to U.S. data, there are more than 3 million hospital discharges each year with heart failure as a diagnosis, with significant short-term rehospitalization and one-year mortality rates. It is the single largest expense to Medicare, accounting for more than $13 billion in hospitalization costs. The great majority of acute heart failure patients have fluid accumulation in the lungs (congestion) that causes shortness of breath (dyspnea) and other complications. For these patients, the current standard of care includes diuretics and vasodilators. Available agents from both of these classes of agents have been associated with renal impairment, hypotension and adverse outcomes.

About Relaxin

Relaxin is a naturally occurring peptide hormone that acts as a systemic and renal vasodilator. Elevated levels of relaxin 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, including patients with heart failure.


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SOURCE Corthera Inc.
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