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Nile Therapeutics Announces Positive Phase 1a Results of CD-NP, a Selective NPR-B Agonist in Clinical Development for the Treatment of Heart Failure
Date:10/11/2007

BERKELEY, Calif., Oct. 11 /PRNewswire-FirstCall/ -- Nile Therapeutics, Inc. (OTC Bulletin Board: SPDU), today announced results from a Phase 1a clinical study of CD-NP, Nile's selective NPR-B agonist being developed for the treatment of heart failure. The results of this study will be included in the Company's presentation today at the BIO Investor Forum in San Francisco, CA.

"The development of a peptide that has natriuretic and renal effects, with relatively little effect on blood pressure, is a potentially important achievement. The results of this trial in healthy volunteers have confirmed some of the hypotheses developed during the pre-clinical studies. We were particularly interested to see a clear, dose dependent increase in cGMP, which suggests the molecule activates the NPR receptors." commented Dr. Barrie Massie, Professor of Medicine, University of California, San Francisco, Chief, Cardiology Section, San Francisco VA Hospital, and member of Nile's scientific advisory board.

Study Design

The Phase 1a study was conducted to investigate the safety, tolerability, pharmacokinetics and pharmacodynamic profile of various doses of CD-NP compared to placebo over a four-hour infusion in 22 healthy volunteers. The study evaluated several pharmacodynamic variables which may translate into safety and efficacy in the heart failure population. Nile measured the effect of CD-NP on systemic blood pressure, urinary flow rate, urinary sodium excretion, serum potassium, renal function and cGMP, a secondary messenger of the target receptor and indicator of in-vivo activity.

Study Results

CD-NP was well tolerated with no serious adverse events and all subjects completed the four-hour infusion of placebo, 10, 17.5 or 25 ng/kg/min of CD-NP.

With respect to clinical and biomarker assessments, CD-NP (placebo, 10, 17.5 and 25 ng/kg/min) increased urine flow rate versus baseline (125%, 53%, 30% and 230% average change, respectively), incre
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SOURCE Nile Therapeutics, Inc.
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