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Nile Therapeutics Announces Plans to Pursue a Post-Acute Indication in Heart Failure
Date:2/28/2011

r this post-acute indication. Before the end of the second quarter of 2011, 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 PK/PD trial, Nile intends to initiate a Phase II double-blind, placebo-controlled, dose-ranging clinical trial in post-acute heart failure patients in the first half of 2012.  

"This new path represents the identification of an opportunity that incorporates the current clinical, scientific, and regulatory perspectives on the development of heart failure therapeutics," said James Young, MD, Professor and Executive Dean, Cleveland Clinic Lerner College of Medicine. "Preclinical and clinical data have shown that the natriuretic peptide class can act on multiple disease processes that play a role in the negative outcomes associated with heart failure.  The unique properties of cenderitide provide a sound rationale to support this innovative strategy and could lead to the development of a differentiated product with clinically meaningful benefits."

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 needs. Nile is initially focusing its efforts on developing its lead compound, cenderitide, a novel, rationally designed chimeric peptide for the treatment of heart failure, and CU-NP, a second novel, rationally designed natriuretic peptide.  

More information on Nile can be found at http://www.nilethera.com.

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