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Nile Therapeutics Announces Positive Results from Phase 1b Safety and Pharmacodynamics Study of CD-NP in Patients with Heart Failure
Date:12/9/2008

SAN FRANCISCO, Dec. 9 /PRNewswire-FirstCall/ -- Nile Therapeutics, Inc. (Nasdaq: NLTX), today announced preliminary data from its recently completed multi-center, open-label, ascending-dose Phase 1b clinical study of CD-NP, a novel chimeric natriuretic peptide, in patients with heart failure. Results of this study showed:

  • CD-NP was well tolerated at doses of up to 20 ng/kg/min
  • Blood pressure effects were dose dependent and well characterized
  • CD-NP demonstrated diuretic effects comparable to furosemide
  • CD-NP produced statistically significant changes on biomarkers consistent with enhanced renal function

These positive results are supportive of further study to fully validate proof-of-concept of CD-NP in a Phase 2b clinical trial planned to begin in 2009.

About the Study

The objectives of the Phase 1b study were to establish the maximum tolerated dose (MTD) and to assess the pharmacodynamic effects of CD-NP on blood pressure and renal function in stable heart failure patients. Patients with NYHA Class II or Class III heart failure, ejection fraction <40% and current signs of fluid overload were included in the study. In this dose escalation trial, four cohorts were administered a single 24-hour infusion of CD-NP at a dose of either 3 (n=6), 10 (n=6), 20(n=6) or 30 ng/kg/min (n=2). During the infusion of CD-NP, furosemide and vasoactive therapies were withheld.

Effects on Blood Pressure

The effects on blood pressure were dose-dependent. During a 24-hour infusion of CD-NP at doses of 3, 10 and 20 ng/kg/min, mean reductions in Mean Arterial Pressure were 2.2, 8.9 and 13.2 mmHg respectively.

CD-NP was well-tolerated at dos
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SOURCE Nile Therapeutics, Inc.
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