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

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 patients with heart failure. Results from Nile's Phase Ib and Phase IIa trials are expected to be available in 2008.

About CD-NP

CD-NP is a novel chimeric natriuretic peptide in clinical development for an initial indication of acute decompensated heart failure (ADHF). CD-NP was rationally designed by scientists at the Mayo Clinic's cardio-renal research labs. Current therapies for ADHF, including B-type natriuretic peptide, have been associated with favorable pharmacologic effects, but have also been associated with hypotension and decreased renal function which limit their utility in clinical practice. CD-NP was designed to preserve the favorable effects of current therapies while preventing or attenuating the hypotensive response, and enhancing or preserving renal function.

About Nile Therapeutics

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. Nile is initially focusing its efforts on developing its lead compound, CD-NP, a novel rationally designed chimeric peptide in clinical studies for the treatment of heart failure; 2NTX-99, a small molecule, pre-clinical, anti-atherothrombotic agent with nitric oxide donating properties; and CU-NP, a novel rationally designed natriuretic peptide. A key component of the company's strategy is to acquire the global rights to additional compounds to expand its portfolio. More information on Nile can be found at

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, outlook, milestones, the success of Nile's product development, future financial position, future financial results, plans and objectives of management are forward-looking statements. We may not actually achieve these plans, intentions or expectations and Nile cautions investors not to place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various important factors that could cause actual results or events to differ materially from the forward-looking statements that we make are described in greater detail in the reports we file with Securities and Exchange Commission, including the "Risk Factors" section in Item 1 of the Form 10-KSB we filed with the Securities and Exchange Commission on March 27, 2008. Nile is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

SOURCE Nile Therapeutics, Inc.
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