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May 15, 2009
Nile Therapeutics CD-NP Clinical Program for Acute Heart Failure Released From Clinical Hold by FDA
SAN FRANCISCO, May 15 -- Nile Therapeutics, Inc. (NASDAQ: NLTX), a
company focused on the development of novel therapeutics for heart failure patients,
received notification from the U.S. Food and Drug Administration (FDA) that the agency
has released the Company’s CD-NP development program from clinical hold.
As the next step, the Company will submit to the FDA the finalized protocol for the
Company’s planned 30-patient single-blind, placebo-controlled Phase 2 study 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 renal insufficiency. The dosing of
the study is expected to be completed by the end of 2009.
About CD-NP
CD-NP is a novel chimeric natriuretic peptide in clinical development for the treatment
of acute heart failure. CD-NP was designed to reduce symptoms of dyspnea in heart
failure patients through both a reduction in intracardiac pressure and an improvement in
renal function. The Company believes that the current preclinical and clinical data
supports the pharmacological hypothesis at doses that have been safely tolerated by
patients, and provides CD-NP with the potential for favorable differentiation from other
acute heart failure therapies. In addition to an initial indication for acute heart failure,
CD-NP may have utility in other indications, which include preservation of cardiac
function subsequent to acute myocardial infarction (AMI), and prevention of renal
damage subsequent to cardiac surgery.
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, CDNP,
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.
+1-415-875-7880
info@nilethera.com
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