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Nile Therapeutics Completes Dosing of Phase II Study

SAN FRANCISCO, July 7 /PRNewswire-FirstCall/ -- Nile Therapeutics, Inc. (Nasdaq: NLTX), a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, today announced that it has completed the dosing of the last patient in NIL-CDNP-CT005, an open-label, single-blind, placebo-controlled Phase II study of CD-NP in patients with acute decompensated heart failure, or ADHF. The study was designed to provide additional information on the safety and tolerability of CD-NP when infused for up to 72 hours in patients with ADHF and mild to moderate renal insufficiency.  Additional endpoints included assessments of symptom relief and effects on biomarkers of heart failure and renal function.  

"We are very pleased with the progress of this trial and look forward to reviewing the final clinical data. We are also very proud and impressed with the hard work of the clinical sites and investigators.  Nile looks forward to building upon these relationships and the experience gained from this trial to optimally design and execute our future studies," said Hsiao D. Lieu, M.D. VP of Clinical Research for Nile.

In total, 77 patients were randomized into six cohorts at one of four doses of CD-NP (1.25, 2.5, 3.75 and 5 ng/kg/min) or placebo. Two cohorts were enrolled at each of the 1.25 and 2.5 ng/kg/min dose levels, which preliminary data suggest are the doses with the most attractive clinical profile to investigate in future ADHF studies.  Over 35% of patients were enrolled in the U.S., with the remaining patients enrolled in Israel and Germany. Nile expects the last patient visit to occur at the end of July. Final results from the study are expected in the fourth quarter of 2010.

"We are extremely pleased to announce the completion of enrollment for this study and look forward to being able to discuss our data later this year," said Joshua A. Kazam, Nile's CEO. "We believe that CD-NP has the potential to be an exciting new therapy that provides unique clinical benefit to patients with cardiovascular and renal disease.  Our next steps in the development of CD-NP as therapy for acute heart failure are to finalize the design of a double-blind, placebo controlled Phase IIb study and to discuss that trial design with the FDA and other regulatory authorities.  We look forward to those discussions and to the continued advancement of the CD-NP program."

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 is initially focusing its efforts on developing its lead compound, CD-NP, a novel, rationally designed chimeric peptide in clinical studies for the treatment of heart failure, and CU-NP, a second novel, rationally designed natriuretic peptide. More information on Nile can be found at

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 the timing, progress and anticipated results of the clinical development, regulatory processes, clinical trial and data analysis timelines, anticipated benefits of CD-NP, 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 raise additional capital to fund its product development programs to completion, Nile's reliance on third-party researchers to develop its product candidates, 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, 2009 filed with the Securities and Exchange Commission on March 3, 2010. 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.

SOURCE Nile Therapeutics, Inc.
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