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The single-blind, placebo-controlled Phase 2 study is designed to provide additional information on the safety and tolerability of CD-NP when infused for up to 72 hours in patients with acute heart failure and mild to moderate renal insufficiency. Additional exploratory endpoints will include assessments of CD-NP's ability to relieve symptoms of acute heart failure and its effects on biomarkers of heart failure and renal function. The study is expected to enroll approximately 30 to 40 patients in the United States, Germany and Israel and will examine up to 3 doses of CD-NP.
"Currently there is a significant unmet need in acute heart failure for treatments that can both relieve symptoms and also preserve or enhance renal function in these patients," said Dr. James Young, MD, George & Linda Kaufman Chair and Professor, Cleveland Clinic, and the principal investigator on the study. "The potential of CD-NP to meet both of these objectives is a compelling scientific story, and is of particular clinical importance for the approximately two-thirds of heart failure patients with pre-existing renal dysfunction."
Previously reported results of a Phase 1b study in chronic heart failure patients showed that CD-NP infusion was associated with an improvement in renal function. Previously reported interim results from the first cohort of a Phase 2a study in patients hospitalized for acute heart failure also showed that CD-NP infusion was associated with clinically meaningful improvements in cardiac filling pressures, which are expected to correlate with improvement in symptoms in acute heart failure.
"This trial is a step forward toward our understanding of CD-NP in acute heart failure patients with renal compromise," said Joshua Kazam, CEO of Nile. "We expect results from this study to provide important information about the safety and pharmacologic activity of CD-NP in the intended patient population, and will guide dose selection for a larger Phase 2b study in acute heart failure."
Nile expects to announce interim results of the study later this year, with results from the full study available in 2010.
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 novel rationally designed natriuretic peptide. 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 the timing, progress and anticipated results of the clinical development, regulatory processes, clinical trial 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, 2008 filed with the Securities and Exchange Commission on March 12, 2009. 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.
http://www.nilethera.com
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