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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

iuretics; and -- the absence of treatment failure. Treatment failure was defined as: -- death; -- readmission to the hospital for heart failure within seven days of the first dose of KW-3902 or placebo; -- worsening of heart failure; or -- worsening renal function.

Patients treated with 30 milligrams of KW-3902 showed higher rates of treatment success and lower rates of treatment failure compared to the placebo group.

The pilot study also showed that 24-hours after treatment, self-reported marked or moderate improvement in dyspnea was observed in 66 percent of the patients who received the 30 milligram dose of KW-3902 as compared to 51 percent in the placebo group.

There were no statistical differences or trends in adverse events observed in the pilot study. The results of the study confirmed that 30 milligrams of KW-3902 is an appropriate dose for NovaCardia's two 600-patient pivotal Phase 3 trials, PROTECT 1 and PROTECT 2, which are currently enrolling participants in the United States, Canada, Europe, Israel and Russia.

KW-3902 is believed to block adenosine-mediated constriction of blood flow to the kidneys and inhibit reabsorption of salt and water by the kidney, thereby increasing urine volume and maintaining renal function in patients with CHF. As renal function deteriorates in patients with CHF, higher doses of diuretics are required in order to reduce fluid overload.

Multiple studies have demonstrated that renal dysfunction is a strong independent predictor of worse short- and long-term outcomes in patients with CHF. In the NovaCardia pilot study, the 30 milligram dose of KW-3902 also showed a positive effect on patients' renal function over time compared to placebo. Although KW-3902 was administered for only the first three days of the trial, an apparent dose response was seen in serum creatinine, a commonly used marker of worsening renal function, at day 14. The study showed no
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