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Pilot Phase 3 Results of NovaCardia's KW-3902 for Acute Congestive,Heart Failure Presented at Late-Breaking Session of Heart Failure,Congress 2007

HAMBURG, Germany, June 11, 2007 /PRNewswire/ -- NovaCardia, Inc. today presented preliminary results from a pilot Phase 3 trial of KW-3902, an adenosine A1 receptor antagonist in development for the treatment of patients with acute congestive heart failure (CHF), that indicate a strong trend toward efficacy for the 30 milligram dose. Patients treated with KW-3902 experienced a higher rate of improvement in dyspnea, or shortness of breath, which is a common symptom of CHF, compared to the placebo group, and the results also show that KW-3902 enhances diuresis and mitigates deterioration of renal function that is often experienced by patients undergoing standard treatment. The findings were summarized by Marco Metra, M.D., University of Brescia, Italy and Gadi Cotter, M.D., Duke University School of Medicine, in a Late-Breaking Trials Session at the European Society of Cardiology's Heart Failure Congress 2007 in Hamburg, Germany.

Drs. Metra and Cotter presented preliminary 14-day data from 276 patients out of 304 total patients enrolled in the pilot Phase 3 trial. Hospitalized patients with acute CHF with renal impairment, which was defined as having creatinine clearance of 20 to 80 milliliters per minute, were randomized to placebo or 10, 20 or 30 milligram doses of intravenous KW-3902 administered daily for up to three days. All patients also received intravenous furosemide. In the double-blind trial, 225 patients received KW-3902 and 79 patients received placebo. The trial was not designed to assess the statistical significance of effects.

The primary endpoint for the pilot Phase 3 trial was the proportion of patients in the categories of treatment failure, success or no change. Treatment success was defined as:

    -- improvement in patient-reported dyspnea within 48 hours;

    -- physician determination of patient improvement resulting in conversion

       from intravenous to oral d
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