Nile Therapeutics Announces Dosing of First Patient in Phase I Study of Cenderitide

SAN MATEO, Calif., May 3, 2011 /PRNewswire/ -- Nile Therapeutics, Inc. (Nasdaq: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced dosing of the first patient in a Phase I clinical trial investigating the use of subcutaneous cenderitide.  The trial is being conducted pursuant to Nile's previously announced collaboration with Medtronic and is the first clinical step towards developing cenderitide as a treatment for the post-acute heart failure space, a strategy which was recently granted Fast Track status by the United States Food and Drug Administration (FDA).

"This clinical trial signals the beginning of a new paradigm in the development of therapies for heart failure patients," said James Young, MD Professor and Executive Dean, Cleveland Clinic Lerner College of Medicine. "Administration of cenderitide on an outpatient basis could change how heart failure patients are treated and has the potential to reduce re-hospitalizations by targeting multiple aspects of the heart failure disease process."

The Phase I clinical trial is a placebo-controlled study designed to evaluate pharmacokinetic and pharmacodynamic actions of cenderitide when administered to chronic heart failure patients as a subcutaneous infusion or as a subcutaneous bolus injection. In the first part of the trial, patients will receive two subcutaneous bolus injections of cenderitide.  In the second part of the trial, patients will receive either a 24 hour continuous infusion of cenderitide or placebo, delivered through Medtronic's subcutaneous pump technology. The primary purpose of the trial is to understand the doses required to achieve pre-determined plasma levels of cenderitide delivered through a subcutaneous infusion pump and the pharmacodynamic activity at these doses.

"This clinical trial is a key first step in our post-acute development program. The FDA's recent grant of Fast Track designation and Medtronic's entry into a collaboration agreement to support us in the current trial emphasize the regulatory and commercial interest in cenderitide's potential to address an important unmet medical need for heart failure patients," said Joshua Kazam, Nile's Chief Executive Officer.

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 initially focusing its efforts on developing its lead compound, cenderitide, 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 Nile's plans to develop cenderitide in the post-acute setting, the anticipated benefits of cenderitide for patients in the post-acute setting, and Nile's ability to obtain FDA approval of cenderitide in the post-acute setting, 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 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, 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.

SOURCE Nile Therapeutics, Inc.

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