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Nile Therapeutics Announces Dosing of First Heart Failure Patient in Phase Ib Study of CD-NP
Date:2/6/2008

BERKELEY, Calif., Feb. 6 /PRNewswire-FirstCall/ -- Nile Therapeutics, Inc. (OTC Bulletin Board: NILT), today announced that the first heart failure patient has been dosed in its Phase Ib, multi-center, open-label, ascending dose clinical study of the company's lead product candidate, CD-NP, a novel chimeric natriuretic peptide, in development for the treatment of acute decompensated heart failure.

"We are very excited that dosing has begun in this important dose- escalation study of CD-NP in heart failure patients," said Peter Strumph, Chief Executive Officer of Nile. "CD-NP has the potential to fill a large unmet medical need in the treatment of heart failure. This trial provides us our first opportunity to assess the drug's activity in heart failure patients, and to further build on our understanding of the molecule's mechanism of action."

The primary objectives of the study are to assess the safety and tolerability of intravenous infusions of CD-NP in patients with heart failure. Safety assessments include measurement of blood pressure, heart rate, serum potassium and kidney function as calculated by glomerular filtration rate (GFR). Clinical assessments include urine flow rate, sodium excretion rate and plasma cGMP, a secondary messenger of the target receptor. The trial is expected to enroll up to approximately 35 patients. Results from the trial are expected to be available in 2008.

About CD-NP

CD-NP is a rationally-designed synthetic peptide that combines selected components of naturally occurring natriuretic peptides to create a novel, NPR- B agonist which has a favorable pharmacological profile with potent renal enhancement and cardiac unloading properties, but minimal hypotensive effects. Data from Nile's recently completed Phase Ia study in 22 healthy volunteers was consistent with several pre-clinical findings, including that CD-NP was associated with increased levels of plasma cGMP, a secondary messenger of the target
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SOURCE Nile Therapeutics, Inc.
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