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Nile Therapeutics Announces Positive Interim Data from Phase 2a Study of CD-NP in Patients with Heart Failure
Date:10/14/2008

nd of decreasing right atrial pressure (RAP) and increasing cardiac output during i.v. infusion of CD-NP; however, these trends did not reach statistical significance in this initial sample of patients.

Importantly, these favorable hemodynamic effects of CD-NP were observed with minimal changes in blood pressure relative to baseline. No hypotension or clinically significant blood pressure reductions were observed during the study.

Effects on Renal Function

Based on the interim data, CD-NP elicited a statistically significant increase in urine output during infusion at both dose levels administered. Notably, the increase by CD-NP represents an increase to the baseline urine outflow established by concurrent infusion of furosemide. During the 3 ng/kg/min infusion of CD-NP, there was an increase in hourly urine output of 48 mL/hr (p=0.01) compared to the pre-dose baseline period. Infusion of 10 ng/kg/min CD-NP resulted in an increase in the hourly urine output of 93 mL/hr (p<0.01) compared to the pre-dose baseline period. Serum creatinine remained unchanged during the infusion period. These data suggest that CD-NP may preserve renal function in this patient population.

"The rate and magnitude of the reduction in PCWP is suggestive of a potential role for CD-NP in rapid relief of symptoms in acute decompensated heart failure patients," said Uri Elkayam, M.D., Director of the Heart Failure Program at the University of Southern California. "The reduction in PCWP and RAP combined with minimal blood pressure changes and improved urine flow are supportive of CD-NP's proposed mechanism of action as a venodilator that will preserve or improve renal function. Renal insufficiency is a major predictor of morbidity and mortality in this patient population, and there is a clear unmet medical need for novel heart failure therapeutics that are renal protective."

"We are excited to announce data that are consistent with our hypothesis that CD-NP is a
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SOURCE Nile Therapeutics, Inc.
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