Renal Insufficiency

Nile Therapeutics, Inc. Announces Dosing of First Patient in Phase 2 Study of CD-NP for the Treatment of Acute Heart Failure

The single-blind, placebo-controlled Phase 2 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 United States, Germany and Israel and will examine up to 3 doses of CD-NP.

"Currently there is a significant unmet need in acute heart failure for treatments that can both relieve symptoms and also preserve or enhance renal function in these patients," said Dr. James Young, MD, George & Linda Kaufman Chair and Professor, Cleveland Clinic, and the principal investigator on the study. "The potential of CD-NP to meet both of these objectives is a compelling scientific story, and is of particular clinical importance for the approximately two-thirds of heart failure patients with pre-existing renal dysfunction."

Previously reported results of a Phase 1b study in chronic heart failure patients showed that CD-NP infusion was associated with an improvement in renal function. Previously reported interim results from the first cohort of a Phase 2a study in patients hospitalized for acute heart failure also showed that CD-NP infusion was associated with clinically meaningful improvements in cardiac filling pressures, which are expected to correlate with improvement in symptoms in acute heart failure.

"This trial is a step forward toward our understanding of CD-NP in acute heart failure patients with renal compromise," said Joshua Kazam, CEO of Nile. "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 2b study in acute heart failure."

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

Keywords: Cardiology, Clinical Trial Research, Heart Failure, Kidney, Nephrology, Renal Function, Renal Insufficiency, Therapy, Treatment, Nile Therapeutics Inc.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.