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Clinical Update - Debio 0614 (Istaroxime) in Acute Heart Failure
Date:4/2/2008

LAUSANNE, Switzerland, and POMEZIA, Italy, April 2 /PRNewswire/ --

- Presentation of Phase IIa Efficacy Results

Debiopharm Group (Debiopharm), a global independent biopharmaceutical development specialist focusing on serious medical conditions, particularly oncology and cardiology, and sigma-tau Industrie Farmaceutiche Riunite SpA (sigma-tau), a leading Italian pharmaceutical group, today presented positive efficacy results of a phase IIa Horizon-HF study with Debio 0614 (formerly PST2744), also known as istaroxime, in development for the treatment of acute heart failure. Data showed that Debio 0614 is able to significantly reduce pulmonary congestion in patients admitted with worsening heart failure and left ventricular dysfunction. These findings were presented at the 57th American College of Cardiology (AAC) Annual Meeting in Chicago, by Mihai Gheorghiade, Professor of Medicine and Surgery at Northwestern University, Chicago and chair of the steering committee of the study.

The results of the study demonstrated that in patients with decompensated heart failure, Debio 0614 improves hemodynamics and diastolic function, without adversely affecting neurohormones or renal function. In this randomized, double-blind, placebo-controlled, multicenter trial, 120 patients were admitted with worsening heart failure, with a left ventricular ejection fraction below 35% and a pulmonary capillary wedge pressure above 20 mmHg. In 30 patients who received three doses of Debio 0614 over six hours, a statistically significant decrease of pulmonary wedge pressure (p<0.03 for all doses) was observed, with a reduction of the left ventricular diastolic volume (p=0.02 for the highest dose) and an increase in cardiac index (p=0.04 for the highest dose), compared to patients treated with placebo.

"Debio 0614 is a novel intravenous agent combining inotropic and lusitropic properties. Its innovative mechanism of action allows for improving systolic and dias
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SOURCE The Debiopharm Group
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