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Nile Therapeutics Completes Dosing of Clinical Trial Evaluating the Subcutaneous Infusion of Cenderitide in Chronic Heart Failure Patients
Date:10/18/2011

SAN MATEO, Calif., Oct. 18, 2011 /PRNewswire/ -- Nile Therapeutics, Inc. (OTCQB: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced that it has completed patient dosing of an open-label Phase I clinical trial evaluating pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of subcutaneous bolus and subcutaneous infusion of cenderitide in patients with chronic heart failure. The trial was conducted pursuant to Nile's previously announced collaboration with Medtronic and was an important step towards developing cenderitide as a 90-day outpatient treatment for heart failure patients following admission for acutely decompensated heart failure (ADHF), referred to as the "post-acute" treatment period. This program was granted Fast Track status by the United States Food and Drug Administration.

The Phase I clinical trial was a placebo-controlled study evaluating PK and PD of cenderitide when administered to chronic heart failure patients as a subcutaneous bolus injection or as a subcutaneous infusion. The trial was designed to understand the doses required to achieve pre-determined plasma levels of cenderitide when delivered through a subcutaneous infusion pump. In Part A of the trial, 12 patients received two subcutaneous bolus injections of cenderitide.  In Part B of the trial, 34 patients received a 24-hour continuous infusion of either of two fixed doses of cenderitide or placebo, delivered through Medtronic's subcutaneous pump technology.

In September, Nile added a Part C to the trial, with an objective to confirm an observed relationship between a patient's weight and cenderitide's pharmacokinetics. In Part C, 12 patients received a 24-hour continuous infusion of either a weight-based dose of cenderitide, or placebo, delivered through Medtronic's subcutaneous pump technology.

"We achieved our objectives for this trial, which was to determine dosing levels for t
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SOURCE Nile Therapeutics, Inc.
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