Nile Therapeutics Announces Dosing in Second Phase Ib Study of CD-NP in Heart Failur... ( SAN FRANCISCO July 30 /- Nile The...)

Nile Therapeutics Announces Dosing in Second Phase Ib Study of CD-NP in Heart Failure Patients

Date:7/30/2008

SAN FRANCISCO, July 30 /PRNewswire-FirstCall/ -- Nile Therapeutics, Inc. (Nasdaq: NLTX), today announced that Mayo Clinic has initiated a Phase Ib, 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 enroll 27 heart failure patients.

"We are delighted that dosing has begun in this important Phase Ib 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 Ia 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 Ib study, Nile is currently dosing Phase Ib and Phase IIa studies of CD-NP in heart failure patients. The primary objective of the Phase Ib 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 IIa study is to assess hemodynamic effects of intravenous infusions of CD-NP in pati
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SOURCE Nile Therapeutics, Inc.
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Nile Therapeutics Announces Dosing in Second Phase Ib Study of CD-NP in Heart Failur...( SAN FRANCISCO July 30 /- Nile The...),Health