Navigation Links
NicOx Announces Second Naproxcinod Pivotal Phase 3 Study (302) Meets Efficacy Primary Endpoints and Supports Non-Detrimental Blood Pressure Effect
Date:9/15/2008

PARIS, September 15 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced successful top-line results from the second phase 3 study for naproxcinod in 1020 patients with osteoarthritis of the knee (the 302 study). Both doses of naproxcinod (750 mg and 375 mg bid) met the three co-primary efficacy endpoints at week-13 (p<0.001). The study also comfortably met the main secondary endpoint, demonstrating that naproxcinod 750 mg bid was statistically non-inferior to naproxen 500 mg bid on the WOMAC(TM) pain and function subscales at week-13 and 26. Naproxcinod is the first compound in the new Cyclooxygenase-Inhibiting Nitric Oxide-Donator (CINOD) class of anti-inflammatory agents, which NicOx is developing as a drug for the treatment of the signs and symptoms of osteoarthritis.

NicOx' phase 3 clinical program for naproxcinod consists of three pivotal trials (including the previously completed 301 study in osteoarthritis of the knee and the ongoing 303 study in osteoarthritis of the hip, in addition to the 302 study). Overall, the results of the 302 study support naproxcinod's non-detrimental effect on blood pressure and are consistent with those observed in the 301 study, with naproxcinod 750 mg bid showing a numerical reduction in systolic and diastolic blood pressure at week-13 and 26, compared to baseline and naproxen 500 mg bid. Existing non-steroidal anti-inflammatory agents (NSAIDs) such as ibuprofen and naproxen have the tendency to raise blood pressure, which is a side effect of particular concern in the osteoarthritis population.

A post hoc pooled analysis of the blood pressure data from the 301 and 302 studies showed a statistically significant reduction for naproxcinod 750 mg bid, compared to naproxen 500 mg bid, in terms of the mean change from baseline at week-13, of 2.3 mmHg (p=0.004) for systolic blood pressure and 1.1 mmHg (p=0.034) for diastolic blood pressure. In the planning of the phase 3 program, NicOx had fo
'/>"/>

SOURCE NicOx
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. NicOx Announces Top-Line Results From Naproxcinod 52-Week 301 Safety Extension
2. NicOx Completes Enrollment of Two Ambulatory Blood Pressure Measurement (ABPM) Studies for Naproxcinod in Hypertensive OA Patients
3. NicOx Announces Blood Pressure Analysis From 301 Phase 3 Study for Naproxcinod at EULAR
4. NicOx Completes Patient Enrollment in Third Naproxcinod Pivotal Phase 3 Study
5. NicOx Announces Initiation of First Phase 1 Study of Investigational Nitric Oxide-Donating Agent in Hypertensive Patients by Merck & Co., Inc.
6. Financial Results for Full Year 2007: NicOx Significantly Advances Clinical Programs
7. NicOx Announces Pfizer Initiates Phase 2 Clinical Development for PF-03187207 in Japan
8. NicOx Completes Enrollment in Second Pivotal Phase 3 Study for Naproxcinod and Provides Development Update
9. NicOx Announces TOPIGEN Initiates Phase 2 Proof of Concept Study in COPD for TPI 1020
10. NicOx Naproxcinod Phase 3 Results Presented at American College of Rheumatology
11. NicOx Naproxcinod ABPM Data Presented at American Heart Association
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/16/2014)... , Sept. 16, 2014  Denovo Biopharma, LLC, ... late-stage oncology drug, from Eli Lilly and Company ... manufacture and commercialize enzastaurin globally, including transfer of ... information. Lilly developed enzastaurin in ... and Phase 3 clinical trials for diffuse large ...
(Date:9/16/2014)... Wash. , Sept. 16, 2014 /PRNewswire/ ... a late stage development company engaged primarily ... medical isotopes for diagnostic and therapeutic applications, ... for technology related to its brachytherapy products.  ... arise from its license from Battelle, under ...
(Date:9/16/2014)... -- Russia,s pharmaceutical ... Pharma 2020 Strategy provides incentives for local producers to ... foreign markets. These trends, however, were affected by recent ... political and economic sanctions imposed on Russia ... Russia responded to the US ...
Breaking Medicine Technology:Denovo Biopharma Acquires Late-Stage Oncology Drug From lilly For Development As A Personalized Medicine 2Advanced Medical Isotope Corporation Licensed Brachytherapy Seed Patent Granted 2Advanced Medical Isotope Corporation Licensed Brachytherapy Seed Patent Granted 3Advanced Medical Isotope Corporation Licensed Brachytherapy Seed Patent Granted 4Global Medicines for Russia 2
(Date:9/17/2014)... Irvington, NY (PRWEB) September 17, 2014 ... youth sports, concussion prevention is top of mind ... developed five facts to remember about concussions and ... Treatment, developed for kids, parents, coaches and teachers ... , "As a pediatric orthopedic ...
(Date:9/17/2014)... Lee Berman, a seasoned veteran of ... on The Balancing Act® airing on Lifetime Television®. Berman ... segment will premiere on September 19 and re-air on ... on Lifetime Television®' with show host Julie Moran. Berman ... over a decade and is the Director of Marketing ...
(Date:9/17/2014)... Freeslate, Inc. , the leading ... development, today announced that Baylor University acquired a ... to both support Baylor research interests and provide ... throughput system is expected to significantly accelerate innovation ... for small molecule organic chemistry. , The ...
(Date:9/17/2014)... Presence Technology, a multinational provider ... Suite 10.0, which incorporates significant enhancements to meet ... , The Contact Center Agents and Supervisors will ... get a better feel for the performance of ... and who requires additional coaching or mentoring to ...
(Date:9/16/2014)... BamboofloorChina.com, the popular online supplier of elegant bamboo items, ... bamboo floors to its product catalogue. Along with ... new items; the current discount is up to 27 ... season. Therefore, BamboofloorChina.com spares no energy to offer more ... items offered by BamboofloorChina.com are in stock and ready ...
Breaking Medicine News(10 mins):Health News:Video Helps Kids and Adults Talk About Concussion Recognition and Treatment 2Health News:Lee Berman Will Appear On The Balancing Act® airing on Lifetime Television® 2Health News:Baylor University Selects Freeslate Reaction Screening System to Support New High Throughput Screening Lab 2Health News:Presence Technology’s 10.0 Release Drives Contact Center Web Supervisor Effectiveness While Reducing Operation Costs and Delivering Enterprise Grade Scalability 2Health News:BamboofloorChina.com Announces Its Promotion For Strand Woven Bamboo Floors 2
... VIEJO, Calif., Sept. 19 Clarient, Inc.,(Nasdaq: CLRT ... and the pharmaceutical industry, today announced,that it is scheduled ... Life Sciences Conference at 4:30 p.m. EDT on Wednesday, ... Grand Hyatt in New York City,September 24-27. A ...
... /Xinhua-PRNewswire-FirstCall/ -- To help buyers,identify suppliers offering ... GSOL ) and Bureau Veritas, one ... have launched the B2B industry,s,most comprehensive supplier ... ) Co-developed by the two companies, ...
... volunteers representing the Women,s Dermatologic Society (WDS) will, help ... free skin cancer screenings and sun safety ... PLANO, Texas, Sept. 18 Even though higher altitudes,mean ... balloon,enthusiasts enjoying the upcoming Plano Hot Air Balloon Festival ...
... following statement today on proposed legislation by Senators,Kent Conrad ... to create a,task force to reform Social Security and ... the most successful safety,nets in our nation and any ... be done by the committees of jurisdiction in Congress; ...
... and other tissue in the laboratory in conditions similar to ... The technology, developed and patented by scientists at Durham University ... which allows cells to be grown in a more realistic ... a Petri dish. , Evidence gathered by the research ...
... ELMHURST, Ill., Sept. 18 Secure Services Corp. ... Parke has joined,them as the Director of Business ... northwest suburbs for 22 years. He was an,acknowledged ... of the National Conference of Insurance Legislators (NCOIL). ...
Cached Medicine News:Health News:Clarient to Present at the UBS 2007 Global Life Sciences Conference 2Health News:Supplier Assessments to Help Buyers Identify Reliable China Exporters 2Health News:Supplier Assessments to Help Buyers Identify Reliable China Exporters 3Health News:Supplier Assessments to Help Buyers Identify Reliable China Exporters 4Health News:Sun Safety Outreach to Families Takes Flight at the Plano Hot Air Balloon Festival 2Health News:Sun Safety Outreach to Families Takes Flight at the Plano Hot Air Balloon Festival 3Health News:Cell growth technology promises more successful drug development 2Health News:Cell growth technology promises more successful drug development 3Health News:Former State Representative Terry Parke Joins Secure Services Corp. 2
... thin collagen coated highly compliant ... thin wall construction offers optimal ... Hemacarotid UltraThin Patch provides superb ... and healing, without suture hole ...
The VasoSeal Low Profile device is designed for smaller sheath angiography procedures. VasoSeal Low Profile. Seal your arterial punctures with confidence....
D-Stat Radial is a dry version of the D-Stat together with a compression band, and is designed for the control of surface bleeding from vascular access sites, including the sites on the radial artery...
... engineered to close arteriotomies with ease ... with a simple trigger actvated mechanism, ... deliver sheath gently locks onto the ... the site before, during, and after ...
Medicine Products: