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Nile Therapeutics CD-NP Clinical Program for Acute Heart Failure Released From Clinical Hold by FDA
Date:5/15/2009

SAN FRANCISCO, May 15 /PRNewswire-FirstCall/ -- Nile Therapeutics, Inc. (Nasdaq: NLTX), a company focused on the development of novel therapeutics for heart failure patients, received notification from the U.S. Food and Drug Administration (FDA) that the agency has released the Company's CD-NP development program from clinical hold.

As the next step, the Company will submit to the FDA the finalized protocol for the Company's planned 30-patient single-blind, placebo-controlled Phase 2 study designed to provide additional information on the safety and tolerability of CD-NP when infused for up to 72 hours in patients with acute heart failure and renal insufficiency. The dosing of the study is expected to be completed by the end of 2009.

About CD-NP

CD-NP is a novel chimeric natriuretic peptide in clinical development for the treatment of acute heart failure. CD-NP was designed to reduce symptoms of dyspnea in heart failure patients through both a reduction in intracardiac pressure and an improvement in renal function. The Company believes that the current preclinical and clinical data supports the pharmacological hypothesis at doses that have been safely tolerated by patients, and provides CD-NP with the potential for favorable differentiation from other acute heart failure therapies. In addition to an initial indication for acute heart failure, CD-NP may have utility in other indications, which include preservation of cardiac function subsequent to acute myocardial infarction (AMI), and prevention of renal damage subsequent to cardiac surgery.

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 i
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SOURCE Nile Therapeutics, Inc.
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