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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 acceptable 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 annual inpatient cost of heart failure.

About Nile Therapeutics
Nile Therapeutics, Inc. is a biopharmaceutical company that develops innovative products for the treatment of cardiovascular disease and other areas of unmet medical needs. Nile is focusing its efforts on developing its lead compound, cenderitide, a novel rationally designed chimeric peptide in clinical studies for the treatment of heart failure. The cenderitide program was granted Fast Track status by the United States Food and Drug Administration. More information on Nile can be found at http://www.nilethera.com.

Safe Harbor Paragraph for Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Nile's plans to develop cenderitide in the post-acute setting, the anticipated benefits of cenderitide for patients in the post-acute setting, Nile's belief about the viability of its strategy to develop cenderitide using a subcutaneous pump technology, Nile's plans for further development of cenderitide and its ability to fund such development, Nile's ability to obtain FDA approval of cenderitide in the post-acute setting and Nile's beliefs about the potential impact of a decrease of the ADHF re-hospitalization rate on the quality of life for patients and cenderitide's ability to reduce the financial burden of ADHF on the healthcare system, are forward-looking statements. Forward-looking statements also include statements regarding the timing, progress and anticipated results of the clinical development, regulatory processes, clinical trial timelines, expected patient enrollment, anticipated benefits of cenderitide, Nile's strategy, future operations, outlook, milestones, the timing and success of Nile's product development, future financial position, future financial results, plans and objectives of management are forward-looking statements. Nile may not actually achieve these plans, intentions or expectations and Nile cautions investors not to place undue reliance on Nile's forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Nile makes. Various important factors that could cause actual results or events to differ materially from the forward-looking statements that Nile makes include Nile's need to obtain additional capital to fund its product development programs to completion, Nile's reliance on third-party researchers to develop its product candidates, the final results of the Phase I trial of cenderitide may not support Nile's preliminary findings, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in greater detail in the reports Nile files with Securities and Exchange Commission, including those described under the caption "Risk Factors" in Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2010 filed with the Securities and Exchange Commission on March 14, 2011. Nile is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.


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