Nile Therapeutics Announces Dosing In Phase IIa Study Of CD NP In Heart Failure Patients

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 12 Jul 2008 - 0:00 PDT

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Nile Therapeutics, Inc. (Nasdaq: NLTX), announced that it has dosed the first acute setting heart failure patient in its Phase IIa, multi-center, open-label, ascending dose clinical study of the company's lead product candidate, CD-NP, a novel chimeric natriuretic peptide, in development for the treatment of acute decompensated heart failure.

The primary objective of the Phase IIa study is to assess hemodynamic effects of intravenous infusions of CD-NP in patients with heart failure. Key assessments include measurement of pulmonary capillary wedge pressure (PCWP), plasma cGMP, a secondary messenger of the target receptor, blood pressure, heart rate, serum potassium and renal function. Nile expects up to 30 heart failure patients will be enrolled in the trial.

Results from the Phase Ia study in 22 healthy volunteers were consistent with several pre-clinical findings, including that CD-NP was associated with increased levels of plasma cGMP, preserved renal function, increased natriuresis and diuresis with minimal effect on mean arterial pressure. In parallel with the Phase IIa study, Nile is completing its Phase Ib study of CD-NP. The primary objectives of the Phase Ib study are to assess the safety and tolerability of intravenous infusions of CD-NP in patients with heart failure. Results from both the Phase Ib and Phase IIa trials are expected to be available in 2008.

"We are pleased to have reached this important corporate milestone and to be able to begin this Phase II trial of CD-NP in heart failure patients," said Peter Strumph, Chief Executive Officer of Nile. "We look forward to rapidly enrolling this Phase II trial and to further investigating the clinical effects of this novel, rationally designed, chimeric natriuretic peptide."

About CD-NP

Nile's lead compound, CD-NP, is a novel chimeric natriuretic peptide in clinical development for an initial indication of acute decompensated heart failure (ADHF). CD-NP was rationally designed by scientists at the Mayo Clinic's cardio-renal research labs. Current therapies for ADHF, including B-type natriuretic peptide, have been associated with favorable pharmacologic effects, but have also been associated with hypotension and decreased renal function which limit their utility in clinical practice. CD-NP was designed to preserve the favorable effects of current therapies while preventing or attenuating the hypotensive response, and enhancing or preserving renal function.

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 need. 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; 2NTX-99, a small molecule, pre-clinical, anti-atherothrombotic agent with nitric oxide donating properties; 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. More information on Nile can be found at http://www.nilethera.com.

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 our strategy, future operations, outlook, milestones, the success of Nile's product development, future financial position, future financial results, plans and objectives of management are forward-looking statements. We may not actually achieve these plans, intentions or expectations and Nile cautions investors not to place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various important factors that could cause actual results or events to differ materially from the forward-looking statements that we make are described in greater detail in the reports we file with Securities and Exchange Commission, including the "Risk Factors" section in Item 1 of the Form 10-KSB we filed with the Securities and Exchange Commission on March 27, 2008. 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.

Nile Therapeutics, Inc.
http://www.nilethera.com

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