Nile Therapeutics initiates dosing in Phase II heart failure trial

Thu. August 06, 2009; Posted: 09:24 AM

Aug 06, 2009 (Datamonitor via COMTEX) -- NLTX | Quote | Chart | News | PowerRating -- Nile Therapeutics, a biopharmaceutical company, has initiated dosing in a Phase II clinical study of its lead product, CD-NP, for the treatment of acute heart failure.

The single-blind, placebo-controlled Phase II 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 US, Germany and Israel and will examine up to three doses of CD-NP.

Nile expects to announce interim results of the study later in 2009, with results from the full study available in 2010.

Joshua Kazam, CEO of Nile Therapeutics, said: "This trial is a step forward toward our understanding of CD-NP in acute heart failure patients with renal compromise. 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 IIb study in acute heart failure."

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