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Nile Therapeutics Announces Top-Line Results in Clinical Trial Evaluating the Subcutaneous Infusion of Cenderitide, Meets Primary Endpoint
Date:11/16/2011

SAN MATEO, Calif., Nov. 16, 2011 /PRNewswire/ -- Nile Therapeutics, Inc. (OTCQB: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced top-line data from its recently completed Phase I clinical trial evaluating the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of subcutaneous bolus and subcutaneous infusion of cenderitide in patients with chronic heart failure. Nile is 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.

The Phase I clinical trial was designed to understand the doses required to achieve pre-determined plasma levels of cenderitide when delivered through a subcutaneous infusion pump. The target cenderitide plasma levels were based on Nile's previous Phase 2 clinical trials in which cenderitide was delivered through continuous intravenous infusion. 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 subcutaneous infusion of either of two fixed doses of cenderitide or placebo. In Part C, 12 patients received a 24-hour continuous subcutaneous infusion of either a weight-based dose of cenderitide, or placebo. All infusions were delivered through subcutaneous pump technology of Medtronic, Inc. pursuant to the parties' February 2011 development collaboration agreement.

The top line results from the Phase 1 trial are as follows:

  • The primary end-point was met – cenderitide achieved target PK levels when delivered through Medtronic's subcutaneous pump technology;
  • 24 hour subcutaneous delivery of ceneritide through Medtronic's pump technology was well-tolerated, with no injection site irritation;
  • Subcutaneously delivered cenderitide has an acc
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SOURCE Nile Therapeutics, Inc.
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