Nile Therapeutics,
Inc. (Nasdaq: NLTX), announced that Mayo Clinic has initiated a Phase
Ib, double-blind, placebo-controlled clinical study of CD-NP, a novel
chimeric natriuretic peptide, in development for the treatment of acute
decompensated heart failure.
The primary objective of the study is to assess renal, neurohumoral and
non-invasive hemodynamic physiologic parameters of intravenous infusions of
CD-NP in patients with heart failure. Key assessments include glomerular
filtration rate, tubular function, renal plasma flow, urine output, mean
arterial pressure, and various biomarkers. The trial is expected to enroll
27 heart failure patients.
"We are delighted that dosing has begun in this important Phase Ib
study of CD-NP in patients with heart failure," said Peter Strumph, Chief
Executive Officer of Nile. "This Mayo sponsored study, which is the fourth
clinical study of CD-NP, will enable us to continue to build on our
understanding of the clinical effects of CD-NP."
Results from Nile's 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 Mayo's Phase Ib study, Nile is currently dosing Phase
Ib and Phase IIa studies of CD-NP in heart failure patients. The primary
objective of the Phase Ib study is to assess the safety and tolerability of
intravenous infusions of CD-NP in patients with 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. Results from
Nile's Phase Ib and Phase IIa trials are expected to be available in 2008.
About CD-NP
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
nilethera.
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.
nilethera