Navigation Links
Nile Therapeutics Provides Update on Phase II CD-NP Clinical Trial for Acute Heart Failure
Date:3/27/2009

SAN FRANCISCO, March 27 /PRNewswire-FirstCall/ -- Nile Therapeutics, Inc. (Nasdaq: NLTX), a leading company in the development of novel therapeutics for heart failure patients, announced today that, in the course of reviewing the Investigational New Drug (IND) application materials that Nile submitted to the U.S. Food and Drug Administration (FDA) to support the initiation of the Company's Phase IIb clinical trial with CD-NP for the treatment of acute heart failure, the FDA has placed CD-NP on clinical hold. In a letter sent to the Company this week and in a follow-up teleconference with the Company, the FDA requested additional data from the recently completed Phase IIa clinical trial and modifications to CD-NP's Investigator Brochure (IB). The Company is working diligently to respond in a timely manner and expects to be able to provide a complete response to the FDA's requests with recently finalized data from the Phase IIa clinical trial in acute heart failure patients.

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 have direct hemodynamic and renal activity to reduce symptoms of dyspnea, be diuretic and natriuretic and preserve or enhance renal function in heart failure patients. In addition to an initial indication for acute heart failure, CD-NP has potential 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, 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. More information on Nile can be found at http://www.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 Nile's strategy, future operations, outlook, milestones, the timing and success of Nile's product development, the uncertain, lengthy and expensive clinical development and regulatory process, 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 are described in greater detail in the reports Nile files with Securities and Exchange Commission, including the "Risk Factors" section in Item 1A of the Form 10-K Nile filed with the Securities and Exchange Commission on March 12, 2009. 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.


'/>"/>
SOURCE Nile Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. TorreyPines Therapeutics Reports Fourth Quarter and Full Year 2008 Results
2. Oxygen Biotherapeutics, Inc. Adds Oxycyte TBI Clinical Trial Sites in Israel
3. Cornerstone Therapeutics Reports Year Ended December 31, 2008 Financial Results
4. Cell Therapeutics, Inc. Reports Outcome of Special Meeting of Shareholders
5. Cell Therapeutics, Inc. Special Meeting in Lieu of Annual Meeting of Shareholders Scheduled for Tuesday, March 24, 2009
6. Cell Therapeutics Announces Filing of Form 10-K
7. Horizon Therapeutics Selected to Present at InsideVentures Debut Investor Conference March 25-26, Santa Barbara, California
8. Oxygen Biotherapeutics, Inc. Expands Board of Directors
9. Micromet Adds Sir Walter Bodmer and Bernard Fox to Its Advisory Panel for BiTE Antibody Therapeutics
10. Cell Therapeutics Presents Corporate Highlights at Invest Northwest Conference
11. Nile Therapeutics Announces Information in Compliance With NASDAQ Marketplace Rule 4350 and Reiterates 2009 Objectives
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... ... February 24, 2017 , ... FireflySci, Inc is an ... late 2014, FireflySci had the goal of bringing their powerful cuvette and ... shape the path that FireflySci is going on as they add yet another mark ...
(Date:2/23/2017)... YORK , Feb. 23, 2017 ... digital health company, and Digital Noema Telehealth ... remote patient monitoring, announce they are partnering to ... DN Telehealth maximizes collaboration compatibility for its ... beyond a physical clinical setting to include fully ...
(Date:2/23/2017)... 2017  MIODx announced today that it has ... technologies from the University of California, San Francisco ... monitor a patient for response to immune checkpoint ... second license extends the technology with a method ... have an immune-related adverse event (IRAE) from their ...
(Date:2/23/2017)... ... 23, 2017 , ... Brain Sentinel, Inc. has received US ... System, the Brain Sentinel® Seizure Monitoring and Alerting System. The adjunctive seizure monitoring ... of rest. A lightweight, non-invasive monitor is placed on the belly of the ...
Breaking Biology Technology:
(Date:2/21/2017)... N.Y. and PORTLAND, Ore. ... ) and the Avamere Family of Companies (Avamere Health ... today announced a six-month research study that will apply ... improve eldercare at senior living and health centers. By ... Avamere hopes to gain insights into physical and environmental ...
(Date:2/13/2017)... 13, 2017  RSA Conference -- RSA, a Dell ... designed to enhance fraud detection and investigation across ... RSA Fraud & Risk Intelligence Suite. The new ... additional insights from internal and external sources as ... their customers from targeted cybercrime attacks. ...
(Date:2/8/2017)... YORK , Feb. 8, 2017 About ... individual,s voice to match it against a stored ... such as pitch, cadence, and tone are compared ... require minimal hardware installation, as most PCs already ... for different transactions. Voice recognition biometrics are most ...
Breaking Biology News(10 mins):