Nile Therapeutics CD-NP Clinical Program For Acute Heart Failure Released From Clinical Hold By FDA

Main Category: Heart Disease
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 16 May 2009 - 1:00 PDT

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Nile Therapeutics, Inc. (Nasdaq: NLTX), a company focused on the development of novel therapeutics for heart failure patients, received notification from the U.S. Food and Drug Administration (FDA) that the agency has released the Company's CD-NP development program from clinical hold.

As the next step, the Company will submit to the FDA the finalized protocol for the Company's planned 30-patient single-blind, placebo-controlled Phase 2 study 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 renal insufficiency. The dosing of the study is expected to be completed by the end of 2009.

About CD-NP

CD-NP is a novel chimeric natriuretic peptide in clinical development for the treatment of acute heart failure. CD-NP was designed to reduce symptoms of dyspnea in heart failure patients through both a reduction in intracardiac pressure and an improvement in renal function. The Company believes that the current preclinical and clinical data supports the pharmacological hypothesis at doses that have been safely tolerated by patients, and provides CD-NP with the potential for favorable differentiation from other acute heart failure therapies. In addition to an initial indication for acute heart failure, CD-NP may have utility in other indications, which include preservation of cardiac function subsequent to acute myocardial infarction (AMI), and prevention of renal damage subsequent to cardiac surgery.

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. A key component of the company's strategy is to acquire the global rights to additional compounds to expand its portfolio.

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 and amended on April 23, 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