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Nile Therapeutics Reports 2010 Fourth Quarter and Full Year Financial Results
Date:3/14/2011

entific Sessions in early April.

Nile recently announced plans to develop cenderitide as an outpatient therapy to be delivered to ADHF patients continuously for up to 90 days after discharge from the hospital. The first 90 days following admission to the hospital is a critical time for heart failure patients who are known to have combined rates of re-admission and mortality as high as 50% during that period. Nile believes that the cardiac unloading and renal preserving properties of cenderitide could have a significant benefit to patients during a critical time in their recovery from acute heart failure. This is a novel therapeutic space for natriuretic peptides that has been termed "post-acute." Nile also recently announced plans to collaborate with Medtronic, Inc., which will fund and provide its drug-device expertise as Nile executes on its Phase 1 clinical trial. In the trial, cenderitide will be delivered through Medtronic diabetes pump technology.

As a first step in the post-acute development program, Nile plans to file a new Investigational New Drug (IND) application and to initiate a Phase I pharmacokinetics and pharmacodynamics (PK/PD) clinical trial. Following the Phase 1 study, Nile intends to initiate a larger Phase 2 double-blind, placebo-controlled, dose ranging study in patients admitted to the hospital for acute heart failure. The planned Phase 2 study will evaluate the endpoints of cardiac remodeling, renal function, re-hospitalization and mortality in patients following 90 days of continuous therapy via subcutaneous pump.

About Nile TherapeuticsNile Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops innovative products for the treatment of cardiovascular disease and other areas of unmet medical needs. Nile is initially focusing its efforts on developing its lead compound, cenderitide, a novel rationally designed chimeric peptide in clinical studies for the treatment of heart failure, and CU-NP,
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SOURCE Nile Therapeutics, Inc.
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