Nile Therapeutics, Inc announced that Mayo Clinic has initiated a phase-1b, double-blind, placebo-controlled clinical study of CD-NP, a novel chimeric natriuretic peptide, in development for the treatment of acute decompensated heart failure.

The primary objective of the study is to assess renal, neurohumoral and non-invasive hemodynamic physiologic parameters of intravenous infusions of CD-NP in patients with heart failure. Key assessments include glomerular filtration rate, tubular function, renal plasma flow, urine output, mean arterial pressure, and various biomarkers. The trial is expected to enrol 27 heart failure patients.

"We are delighted that dosing has begun in this important phase-1b study of CD-NP in patients with heart failure," said Peter Strumph, Chief Executive Officer of Nile. "This Mayo sponsored study, which is the fourth clinical study of CD-NP, will enable us to continue to build on our understanding of the clinical effects of CD-NP."

Results from Nile's phase-1a study in 22 healthy volunteers were consistent with several pre-clinical findings, including that CD-NP was associated with increased levels of plasma cGMP, preserved renal function, increased natriuresis and diuresis with minimal effect on mean arterial pressure.

In parallel with Mayo's phase-1b study, Nile is currently dosing phase-1b and phase-2a studies of CD-NP in heart failure patients. The primary objective of the phase-1b study is to assess the safety and tolerability of intravenous infusions of CD-NP in patients with heart failure. The primary objective of the phase-2a study is to assess hemodynamic effects of intravenous infusions of CD-NP in patients with heart failure. Results from Nile's phase-1b and phase-2a trials are expected to be available in 2008.

CD-NP is a novel chimeric natriuretic peptide in clinical development for an initial indication of acute decompensated heart failure (ADHF).

Nile Therapeutics, Inc is a clinical-stage biopharmaceutical company that develops innovative products for the treatment of cardiovascular disease and other areas of unmet medical need.