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:6/23/2016)... 23, 2016  Blueprint Bio, a company dedicated to ... medical community, has closed its Series A funding round, ... "We have received a commitment from Forentis ... need to meet our current goals," stated Matthew ... runway to complete validation on the current projects in ...
(Date:6/23/2016)... -- On Wednesday, June 22, 2016, the NASDAQ ... Dow Jones Industrial Average edged 0.27% lower to finish at ... Stock-Callers.com has initiated coverage on the following equities: Infinity Pharmaceuticals ... NKTR ), Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ ... Learn more about these stocks by accessing their free trade ...
(Date:6/23/2016)... ... 23, 2016 , ... Regulatory Compliance Associates® Inc. (RCA), a ... webinar on Performing Quality Investigations: Getting to Root Cause. This ... charge. , Incomplete investigations are still a major concern to the Regulatory Authorities ...
(Date:6/23/2016)... June 22, 2016  Amgen (NASDAQ: AMGN ... QB3@953 life sciences incubator to accelerate the ... shared laboratory space at QB3@953 was created to help ... obstacle for many early stage organizations - access to ... sponsorship, Amgen launched two "Amgen Golden Ticket" awards, providing ...
Breaking Biology Technology:
(Date:4/28/2016)... April 28, 2016 First quarter 2016:   ... 966% compared with the first quarter of 2015 The ... 589.1 M (loss: 18.8) and the operating margin was 40% (-13) ... Cash flow from operations was SEK 249.9 M (21.2) ... guidance is unchanged, SEK 7,000-8,500 M. The operating margin ...
(Date:4/15/2016)... , April 15, 2016 ... the,  "Global Gait Biometrics Market 2016-2020,"  report to ... http://photos.prnewswire.com/prnh/20160330/349511LOGO ) , ,The global gait biometrics ... of 13.98% during the period 2016-2020. ... angles, which can be used to compute factors ...
(Date:3/29/2016)... March 29, 2016 LegacyXChange, Inc. ... "LEGX" and SelectaDNA/CSI Protect are pleased to announce our ... in a variety of writing instruments, ensuring athletes signatures ... created collectibles from athletes on LegacyXChange will be assured ... the DNA. Bill Bollander , CEO ...
Breaking Biology News(10 mins):