PRESS RELEASE
May
7, 2010
Nile
Therapeutics Completes Dose
Escalation in Ongoing Phase II Study
SAN MATEO, CA, May 7, 2010 --
Nile Therapeutics, Inc. (NASDAQ: NLTX), a company focused on the development of
novel therapeutics for heart failure patients, today announced that it has
completed the dose escalation stage of an ongoing Phase II study of CD-NP in
patients with acute decompensated heart failure. Nile had previously announced that the
study, NIL-CDNP-CT005, was expanded to permit additional dose exploration prior
to proceeding to larger Phase II studies.
“Following a planned interim safety
review with our Data Safety Monitoring Committee and discussion with our
Scientific Advisory Board, we have reached our maximum tolerated dose in this
population, and have identified two doses that appear to have an attractive
safety and activity profile in acute heart failure patients,” said Dr. Hsiao D.
Lieu, the VP of Clinical Research for Nile. “We plan to use the remaining
cohorts in the CT005 study to expand the number of patients exposed at these
doses and confirm safety prior to proceeding to our next Phase II
study.”
“We are extremely pleased with the
enrollment rate over the past several weeks, which has allowed us to reach our
target dose levels ahead of our original schedule,” said Joshua A. Kazam,
Nile’s CEO. “We feel that this is reflective
of the enthusiasm our investigators have for the CD-NP program, and we are
excited to continue progressing our clinical plan.”
To date, 52 of the approximately 75
patients intended for inclusion in the CT005 study have been enrolled. Full data
from the study are expected in late 2010.
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 needs.
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, 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
http://www.nilethera.com.
Contact:
Daron Evans
Chief Financial
Officer
Nile Therapeutics,
Inc.
+1-650-458-2670
info@nilethera.com
Safe Harbor Paragraph for
Forward-Looking
Statements: 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 the timing, progress
and anticipated results of the clinical development, regulatory processes,
clinical trial timelines, anticipated benefits of CD-NP, Nile’s strategy, future
operations, outlook, milestones, the timing and success of Nile’s product
development, future financial position, future financial results, plans and
objectives of management are forward-looking statements. Nile may not actually
achieve these plans, intentions or expectations and Nile cautions investors not
to place undue reliance on Nile’s forward-looking statements. Actual results or
events could differ materially from the plans, intentions and expectations
disclosed in the forward-looking statements Nile makes. Various important
factors that could cause actual results or events to differ materially from the
forward-looking statements that Nile makes include Nile’s need to raise
additional capital to fund its product development programs to completion,
Nile’s reliance on third-party researchers to develop its product candidates,
and its lack of experience in developing and commercializing pharmaceutical
products. Additional risks are described in greater detail in the reports Nile
files with Securities and Exchange Commission, including those described under
the caption "Risk Factors" in Item 1A of its Annual Report on Form 10-K for the
year ended December 31, 2009 filed with the Securities and Exchange Commission
on March 3, 2010. 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.