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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

eptable bioavailability profile;
  • Cenderitide's PK profile achieved steady-state when delivered through subcutaneous infusion;
  • Weight-based dosing reduced PK variability, as compared to a fixed dosing regimen.

  • "We believe the data from this trial proves that dosing cenderitide with subcutaneous pump technology is a viable strategy for dosing heart failure patients in the out-patient setting," said Hsiao Lieu, MD, Vice President of Clinical Research at Nile. "We now believe that we understand the target dose range for continuous subcutaneous delivery of cenderitide to heart failure patients.  In the next clinical trial, a Phase 2 trial, we hope to test our hypothesis that cenderitide can help reduce hospital re-admission in the post-acute period following ADHF."

    "When dosed continuously in the out-patient setting during the post-acute period, we believe cenderitide has the potential to reduce the re-hospitalization rate following ADHF," said Richard Brewer, Executive Chairman Nile. "If effective, cenderitide may be able to fundamentally change the treatment paradigm of ADHF, potentially reducing the overall financial burden of heart failure on the system."

    About Heart Failure
    Heart failure is the fastest-growing clinical cardiac disease in the U.S. according to the American Heart Association, affecting over 5 million Americans. Over 1 million patients in the U.S. each year are hospitalized with ADHF, an acute exacerbation of heart failure. ADHF is the is the most frequent cause of hospital admission in the U.S. for patients older than 65 years, generating annual inpatient costs of more than $35 billion. Within 90 days following admission for ADHF, approximately 40% of patients return to the hospital. Nile believes that a decrease in the ADHF re-hospitalization rate, which is the clinical target of the cenderitide development program, could both improve the quality of life for patients and decrease the ann
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    SOURCE Nile Therapeutics, Inc.
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