SAN FRANCISCO, July 7 /PRNewswire-FirstCall/
— Nile Therapeutics, Inc. (Nasdaq: NLTX), a biopharmaceutical company focused on the
development of novel therapeutics for cardiovascular disease, today
announced that it has completed the dosing of the last patient in
NIL-CDNP-CT005, an open-label, single-blind, placebo-controlled
Phase II study of CD-NP in patients with acute decompensated heart
failure, or ADHF. The study was designed to provide additional
information on the safety and tolerability of CD-NP when infused
for up to 72 hours in patients with ADHF and mild to moderate renal
insufficiency. Additional endpoints included assessments of
symptom relief and effects on biomarkers of heart failure and renal
function.
“We are very pleased with the progress of this trial and look
forward to reviewing the final clinical data. We are also very
proud and impressed with the hard work of the clinical sites and
investigators. Nile looks forward to building upon these
relationships and the experience gained from this trial to
optimally design and execute our future studies,” said Hsiao D. Lieu, M.D. VP of Clinical
Research for Nile.
In total, 77 patients were randomized into six cohorts at one of
four doses of CD-NP (1.25, 2.5, 3.75 and 5 ng/kg/min) or placebo.
Two cohorts were enrolled at each of the 1.25 and 2.5 ng/kg/min
dose levels, which preliminary data suggest are the doses with the
most attractive clinical profile to investigate in future ADHF
studies. Over 35% of patients were enrolled in the U.S., with
the remaining patients enrolled in Israel and Germany. Nile expects the last
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