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Interim Analysis of Top-Line Data From Phase II/III Study Shows Favorable Efficacy & Safety for Corthera's Relaxin in Acute Heart Failure
Date:11/10/2008

ctive was proof-of-concept and dose and endpoint selection. In Phase III RELAX-AHF, the objective is to confirm safety and efficacy. Patients selected for the study presented to the hospital with dyspnea (breathlessness) due to AHF and with elevated blood pressure and renal dysfunction. The Pre-RELAX-AHF/RELAX-AHF study was designed and conducted in collaboration with Momentum Research, headed by Dr. Gad Cotter.

Marco Metra, M.D., Professor of Cardiology at the University of Brescia, Italy, and co-principal investigator of the Pre-RELAX-AHF study, was also a speaker at the symposium. "Patients with AHF remain a major clinical challenge with extremely high morbidity and mortality rates. Promising new agents such as relaxin are needed to treat these patients and improve their outcomes. The data from the Phase II study met the objectives of the proof-of-concept Pre-RELAX-AHF study, allowing the selection of the appropriate dose and endpoints for further study. Progression to the Phase III portion of the study is now clearly warranted," said Dr. Metra.

According to the AHA, heart failure is a costly syndrome contributing to more than three million hospitalizations each year in the U.S. The great majority of patients with acute heart failure 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. 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
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SOURCE Corthera Inc.
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