Navigation Links
Nile Therapeutics Announces Top-Line Results in Clinical Trial Evaluating the Subcutaneous Infusion of Cenderitide, Meets Primary Endpoint
Date:11/16/2011

SAN MATEO, Calif., Nov. 16, 2011 /PRNewswire/ -- Nile Therapeutics, Inc. (OTCQB: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced top-line data from its recently completed Phase I clinical trial evaluating the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of subcutaneous bolus and subcutaneous infusion of cenderitide in patients with chronic heart failure. Nile is developing cenderitide as a 90-day outpatient treatment for heart failure patients following admission for acutely decompensated heart failure (ADHF), referred to as the "post-acute" treatment period.

The Phase I clinical trial was designed to understand the doses required to achieve pre-determined plasma levels of cenderitide when delivered through a subcutaneous infusion pump. The target cenderitide plasma levels were based on Nile's previous Phase 2 clinical trials in which cenderitide was delivered through continuous intravenous infusion. In Part A of the trial, 12 patients received two subcutaneous bolus injections of cenderitide.  In Part B of the trial, 34 patients received a 24-hour continuous subcutaneous infusion of either of two fixed doses of cenderitide or placebo. In Part C, 12 patients received a 24-hour continuous subcutaneous infusion of either a weight-based dose of cenderitide, or placebo. All infusions were delivered through subcutaneous pump technology of Medtronic, Inc. pursuant to the parties' February 2011 development collaboration agreement.

The top line results from the Phase 1 trial are as follows:

  • The primary end-point was met – cenderitide achieved target PK levels when delivered through Medtronic's subcutaneous pump technology;
  • 24 hour subcutaneous delivery of ceneritide through Medtronic's pump technology was well-tolerated, with no injection site irritation;
  • Subcutaneously delivered cenderitide has an acc
    '/>"/>

SOURCE Nile Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Nile Therapeutics Reports 2011 Third Quarter Financial Results
2. Cell Therapeutics, Inc. Reports Results of Annual Meeting of Shareholders
3. Orexigen® Therapeutics Reports Third Quarter Financial Results
4. Silence Therapeutics Provides Corporate and Development Update
5. Halozyme Therapeutics Reports Third Quarter 2011 Financial Results
6. Regado Biosciences, Inc. Presents Positive Efficacy and Safety Substudy Data from the Phase 2b RADAR Trial for the REG1 Anticoagulation System at the Transcatheter Cardiovascular Therapeutics (TCT) Symposium 2011
7. Karyopharm Therapeutics Closes $10 Million Series A2 Financing to Expand Planned Phase 1 Program of Oral Selective Inhibitors of Nuclear Export (SINE) for Cancer
8. Halozyme Therapeutics Announces Data From Two Phase 1 Studies of PEGPH20 Demonstrating Targeting of Hyaluronan in Tumor Stroma
9. United Therapeutics Corporation Reports Third Quarter 2011 Financial Results
10. Amsterdam Molecular Therapeutics Provides Operations Update & Strategic Review of Pipeline
11. Cell Therapeutics, Inc. (CTI) Reports Third Quarter Financial Results and Milestones
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/25/2014)... Investor-Edge has initiated coverage on the following ... Pharmaceuticals Inc. (NASDAQ: VRTX ), Alexion Pharmaceuticals ... (NASDAQ: PPHM ), and StemCells Inc. (NASDAQ: ... accessed at: http://investor-edge.com/register . The US ... positive note as the Dow Jones Industrial Average finished ...
(Date:10/22/2014)... New test innovations will be the source ... test industry, especially as companies struggle with reimbursement challenges, ... than 25 testing innovations in important disease areas in ... products. Kalorama details the new approaches its biennial survey of ... Vitro Diagnostic Tests , 9th Edition . ...
(Date:10/22/2014)... The Americas Inorganic Refrigerants Market report ... Americas with analysis and forecast of revenue. , ... Refrigerants Market report, to get an idea of ... glimpse of the segmentation in the Americas inorganic ... and figures. , http://www.micromarketmonitor.com/market/americas-inorganic-refrigerants-4191654241.html , ...
(Date:10/22/2014)... Involution Studios , a healthcare ... new infographic, Understanding Ebola . The goal ... easy to follow informative tool for anyone wanting to ... and prevention. , "As the news has spread in ... outbreak represents not only a healthcare crisis with global ...
Breaking Biology Technology:Biotech Stocks Technical Data - CytRx, Vertex Pharma, Alexion Pharma, Peregrine Pharma, and StemCells 2Biotech Stocks Technical Data - CytRx, Vertex Pharma, Alexion Pharma, Peregrine Pharma, and StemCells 3Biotech Stocks Technical Data - CytRx, Vertex Pharma, Alexion Pharma, Peregrine Pharma, and StemCells 4Biotech Stocks Technical Data - CytRx, Vertex Pharma, Alexion Pharma, Peregrine Pharma, and StemCells 5Report: Radical New IVD Test Approaches Key To Growth 2Report: Radical New IVD Test Approaches Key To Growth 3The Americas Inorganic Refrigerants Market is estimated to grow to $71.6 million by 2018 - New Report by MicroMarket Monitor 2The Americas Inorganic Refrigerants Market is estimated to grow to $71.6 million by 2018 - New Report by MicroMarket Monitor 3Involution Studios' Ebola Infographic Provides Key Disease Information and Statistics at a Glance 2
... a currently available yet underused vaccine against typhoid fever is ... vaccinees. The study, conducted by the International Vaccine ... and Enteric Diseases (NICED) in Kolkata, India, was published in ... of Medicine (NEJM). The IVI, based in Seoul, Korea, ...
... , , RICHMOND, Calif., July 22 ... that the company will release its second quarter 2009 financial results ... release will be followed by a conference call at 5:00 p.m. ... webcast. During the conference call, the company will review the financial ...
... , , , , ... a development-stage company focused on novel biopolymer implant therapies to treat ... the corporation to CardioPolymers, Inc. , , ... "The name change, which is effective immediately, better reflects our focus ...
Cached Biology Technology:Vi typhoid vaccine proves highly effective in young children 2Vi typhoid vaccine proves highly effective in young children 3Sangamo BioSciences Announces Second Quarter 2009 Conference Call and Webcast 2Sangamo BioSciences Announces Second Quarter 2009 Conference Call and Webcast 3Symphony Medical Changes Name to CardioPolymers, Inc. 2
(Date:10/16/2014)... are anything but sustainable: environmental damage to soil ... increasingly evident. Despite their disadvantages, however, monocultures remain ... the sole possibility of achieving higher yields in ... an ecology professor at the University of Zurich, ... forestry. After all, a new study carried out ...
(Date:10/15/2014)... N.Y. , Oct. 15, 2014 ... solutions for home and community-based care, today announced ... of implementing Sandata,s Santrax® Electronic Visit Verification™ Solution ... Services is a home health company founded in ... Texas . The study ...
(Date:10/15/2014)... The Ebola virus is spreading rapidly and to an ... experienced in the past and the virus shows a ... been recorded before. For this reason, the German National ... of Science and Engineering, and the Union of the ... statement on the Ebola epidemic today. , In the ...
Breaking Biology News(10 mins):Plant communities produce greater yield than monocultures 2Plant communities produce greater yield than monocultures 3Sandata Announces Case Study with Quality Care Services, Inc. 2Academies call for consequences from the Ebola virus epidemic 2Academies call for consequences from the Ebola virus epidemic 3Academies call for consequences from the Ebola virus epidemic 4Academies call for consequences from the Ebola virus epidemic 5
... researchers have found that years after experiencing childhood ... than expected in their elderly counterparts, but rather ... commensurate with normal aging. , "Other researchers have ... later in life, but we've actually found it ...
... of a nation-wide study published in the latest issue ... Physicians in AIDS Care (JIAPAC), HIV positive patients and ... and how it's treated. , The study uncovered differences ... of treatment, the various goals of treatment, and even ...
... of poultry flocks could make the spread of deadly ... at the Universities of Edinburgh and Warwick have found. ... are effective on individual birds, the disease is likely ... been protected. The study, published in Nature journal, is ...
Cached Biology News:Survivors of childhood polio do well decades later as they age 2Bird flu study highlights need to vaccinate flocks effectively 2
...
... This modular benchtop fume hood ... allowing safe indoor release of ... most organic contaminants. Configurations are ... flow; options include final HEPA ...
...
... The Staccato Series of systems provide ... drug discovery , genomics, proteomics and drug ... three base configurations; Mini Workstation Series, Application ... Sciclone ELISA Station is a remarkably compact ...
Biology Products: