Navigation Links
Transave Announces Positive Phase II Results for Once-Daily Arikace(TM) in the Treatment of Cystic Fibrosis Patients Who Have Pseudomonas Lung Infections
Date:6/13/2008

Data Presented at the European Cystic Fibrosis Society Conference

MONMOUTH JUNCTION, N.J., June 13 /PRNewswire/ -- Transave, Inc., today reported positive results from a Phase II clinical trial on its lead investigational drug, Arikace(TM) (liposomal amikacin for inhalation). The compound is being developed for the treatment of cystic fibrosis (CF) patients who have lung infections due to the bacterium Pseudomonas aeruginosa. The Phase II data indicated that Arikace, delivered once daily for 28 consecutive days, produced a significant improvement in lung function, was well-tolerated, and had a side-effect profile comparable to placebo. The Phase II trial was a randomized, double-blind, placebo-controlled study of 64 patients from 15 centers in Europe. Results were presented today at the 31st European Cystic Fibrosis Society (ECFS) Conference in Prague, Czech Republic, by Lieven Dupont, MD, Associate Professor of Respiratory Medicine at the Katholieke Universiteit, Leuven, Belgium, and co-lead investigator of the study.

Arikace is a novel molecular entity comprised of the antibiotic amikacin, which is enclosed in nanocapsules of lipids called liposomes. Arikace was administered once daily for 28 days at 280 mg and 560 mg dosages, using a novel inhalation device, the eFlow(R) Electronic Nebulizer (PARI Pharma GmbH).

The intent-to-treat analysis for efficacy demonstrated that Arikace, when administered once daily either at 280 mg or 560 mg for 28 days, resulted in clinically significant improvement in lung function at the end of treatment. This improvement was dose-dependent and was sustained at 28 days after completion of dosing, which was day 56 of the study. Pulmonary function (FEV1) increased significantly among patients receiving the 560 mg dose of Arikace, with a sustained treatment effect of 224 ml (p=0.004) and 17.6% (p=0.009) increase compared to placebo, at day 56.

Arikace was well tolerated, with no differences observed in
'/>"/>

SOURCE Transave, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. NicOx Announces Blood Pressure Analysis From 301 Phase 3 Study for Naproxcinod at EULAR
2. Vion Pharmaceuticals Announces Presentation of Data of Cloretazine(R) (VNP40101M) in Elderly Patients with High-Risk Myelodysplastic Syndromes at the EHA Annual Meeting
3. XTENT Announces European Regulatory Update
4. PTC Therapeutics Announces Data from Additional Clinical Studies of PTC124 in Cystic Fibrosis Confirming Activity
5. Repligen Announces Plans to Initiate a Phase 2b Trial for RG2417 in Bipolar Disorder
6. Cardiogenesis Announces Preliminary Clinical Results With the PHOENIX System Combining TMR + Stem Cells
7. Targeted Genetics Announces Positive Phase 1/2 tgAAC94 Data Presented at Annual European Congress of Rheumatology
8. Iomai Announces Publication in The Lancet of Phase II Study Demonstrating Significant Efficacy of Travelers Diarrhea Vaccine
9. Morria Biopharmaceuticals Plc Announces Regulatory Approval to Commence Phase II Clinical Study of MRX-4 in Allergic Rhinitis
10. CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial in Melanoma
11. NeurogesX Announces Publication of NGX-4010 Phase 3 HIV-Neuropathy Study Results in Neurology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2014)... , July 24, 2014 Decision Resources Group ... the EU5 countries ( France , ... Spain and the ... of the first once-daily long-acting beta2 agonist/inhaled corticosteroid (LABA/ICS) ... uptake of Relvar as a first-line LABA/ICS FDC in ...
(Date:7/24/2014)... DALLAS , July 24, 2014 /PRNewswire-iReach/ -- ... days once order is placed. Photo ... is a professional and in-depth market survey on ... firstly reviews the basic information of Hemodialysis Machine ... report then explores global and China,s top manufacturers ...
(Date:7/24/2014)... , July 24, 2014   Royal Philips ... announced that it has received 510(k) clearance from the ... ultra mobile ultrasound system, VISIQ, in the U.S. ... combine the benefits of greater mobility, performance and simplicity ... to quality diagnostic scans for more OB patients. ...
Breaking Medicine Technology:Surveyed EU5 Pulmonologists Expect that Relvar, the First Once-Daily LABA/ICS FDC, Will Experience Healthy Uptake in Asthma 2Surveyed EU5 Pulmonologists Expect that Relvar, the First Once-Daily LABA/ICS FDC, Will Experience Healthy Uptake in Asthma 3Hemodialysis Machine Industry for Global and Chinese Markets Forecast to 2019 2Hemodialysis Machine Industry for Global and Chinese Markets Forecast to 2019 3Hemodialysis Machine Industry for Global and Chinese Markets Forecast to 2019 4Hemodialysis Machine Industry for Global and Chinese Markets Forecast to 2019 5Philips receives FDA 510(k) clearance for its innovative ultra mobile VISIQ ultrasound system 2Philips receives FDA 510(k) clearance for its innovative ultra mobile VISIQ ultrasound system 3
... N.C., Feb. 28, 2011 Goodrich Corporation (NYSE: ... advanced helicopter technology that brings real-time information to air ... enhanced safety and rescue systems. Heli-Expo 2011 takes place ... in Orlando, Fla.   Goodrich (booth 2142) ...
... PHILADELPHIA, Feb. 28, 2011 Shire plc , (LSE: ... company, today announced that the US Food and Drug Administration ... Tablets as adjunctive therapy to stimulants for the treatment ... ages 6 to 17 as part of a total treatment ...
Cached Medicine Technology:Goodrich to Showcase Advanced Helicopter Systems at Heli-Expo 2FDA Approves INTUNIV® (guanfacine) Extended-Release Tablets for Use as Adjunctive Therapy to Stimulants for the Treatment of ADHD in Children and Adolescents 2FDA Approves INTUNIV® (guanfacine) Extended-Release Tablets for Use as Adjunctive Therapy to Stimulants for the Treatment of ADHD in Children and Adolescents 3FDA Approves INTUNIV® (guanfacine) Extended-Release Tablets for Use as Adjunctive Therapy to Stimulants for the Treatment of ADHD in Children and Adolescents 4FDA Approves INTUNIV® (guanfacine) Extended-Release Tablets for Use as Adjunctive Therapy to Stimulants for the Treatment of ADHD in Children and Adolescents 5FDA Approves INTUNIV® (guanfacine) Extended-Release Tablets for Use as Adjunctive Therapy to Stimulants for the Treatment of ADHD in Children and Adolescents 6
(Date:7/24/2014)... of Association Executives (ASAE) announced its 2014 Power of ... American Society of Anesthesiologists (ASA). , The ASA ... A Gold Award, one of the top honors from ... of the world through education on the global anesthesia ... care. , ASA was also honored with a Power ...
(Date:7/24/2014)... Lincoln, RI (PRWEB) July 24, 2014 Pools ... days. But the water can be dangerous, especially for small ... to promote water safety. , According to the Centers for ... and 4 are most at risk for water-related injuries and ... young children safe around water, so Amica is offering the ...
(Date:7/24/2014)... SHAWNEE, Kan. (PRWEB) July 24, 2014 ... announces that it has achieved certification for ... as tested and verified by the DoD Information ... Acuo Vendor Neutral Archive, identified within the DoD ... the Authority to Operate designation from the U.S. ...
(Date:7/24/2014)... A new study led by the Translational Genomics ... bacteria, viruses and the immune system during HIV infection. ... potential to infect others based on their blood ... virus in their semen despite having low levels in ... of the virus can be found in different parts ...
(Date:7/24/2014)... (PRWEB) July 24, 2014 In ... Tuesday, President Obama cited the Atlanta BeltLine Workforce ... programs from across the country ( http://www.whitehouse.gov/ready-to-work ... an essential pillar of U.S. economic strategy and ... , “This recognition from President Obama highlights the ...
Breaking Medicine News(10 mins):Health News:Keep Kids Safe in the Water with 5 Tips from Amica 2Health News:Perceptive Software Achieves DIACAP Certification for Vendor Neutral Archive Solution to Support U.S. Department of Defense Integrated Clinical Systems Program 2Health News:Perceptive Software Achieves DIACAP Certification for Vendor Neutral Archive Solution to Support U.S. Department of Defense Integrated Clinical Systems Program 3Health News:Perceptive Software Achieves DIACAP Certification for Vendor Neutral Archive Solution to Support U.S. Department of Defense Integrated Clinical Systems Program 4Health News:TGen-led study seeks to understand why some HIV-positive men are more infectious 2Health News:President Cites Atlanta BeltLine Workforce Partnership in Healthcare as National Model 2Health News:President Cites Atlanta BeltLine Workforce Partnership in Healthcare as National Model 3Health News:President Cites Atlanta BeltLine Workforce Partnership in Healthcare as National Model 4Health News:President Cites Atlanta BeltLine Workforce Partnership in Healthcare as National Model 5
... be participating in the Memory Ride for Alzheimer's Research on ... the disease that affects more than 5 million Americans. ... Memory Ride has a personal story to tell -- about ... struggled with the disease. ,The Alzheimer's Association is ...
... shoes at 5 in the morning after a night of ... party at the Sunset Tower Hotel and looked weary after a ... that Hilton was exhausted after visiting San Francisco for presenting her ... returned to the LA club scene once again, just two weeks ...
... 350 million worldwide. In a new study, UCLA researchers measured ... beyond just the physical symptoms of the disease ... overall well-being, which may help clinicians guide treatment. The study ... ,Our results revealed that to effectively treat hepatitis B ...
... for causing cold sores, may help keep arteries free-flowing ... patients, according to research published early in the ... of Sciences of the United States of America). ... at the University of Chicago Medical Center, and the ...
... study suggests strong variation in the occurrence of anaphylaxis ... severe allergic reaction that can be fatal without treatment ... prescribing, a marker of anaphylaxis risk, currently are without ... vitamin D from lack of sunshine, may play a ...
... Iraqi patients, mostly children and youth, have been cured at ... ,Most of the patients, aged up to 18 years, ... ,A six-year old child underwent an Intra Cardiac Echo ... handful in the country qualified to undergo the complicated surgery ...
Cached Medicine News:Health News:Researchers Develop Tool to Gauge Quality of Life of Hepatitis B Patients 2Health News:Modified Herpes Virus Keeps Arteries Free-flowing Following Procedures 2Health News:Large Geographic Differences in EpiPen Prescriptions in the U. S. 2
Pronto Dry is intended for use for the detection of urease enzyme in gastric mucosal biopsy specimens....
Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of an Helicobacter pylori infection....
... Rapid Test Strip and Device are rapid ... antibodies to Helicobacter pylori (H. pylori) in ... in the diagnosis of H. pylori infection ... older. They are intended for health professionals ...
... The QuickVue H.pylori gII test is ... rapid, qualitative detection of IgG antibodies specific ... or whole blood. It utilizes a convenient, ... to aid physicians in the diagnosis of ...
Medicine Products: