Navigation Links
Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)
Date:5/19/2009

ally significant and clinically meaningful effect on both the primary endpoint of change in percent predicted FVC and secondary endpoints of progression-free survival and categorical change in percent predicted FVC. While CAPACITY 1 did not achieve statistical significance on the primary endpoint, the results were generally consistent with and supportive of CAPACITY 2. Further, the treatment effect observed in the CAPACITY studies was generally consistent with that observed in the Phase 3 study of pirfenidone in IPF patients conducted by Shionogi & Co. Ltd. in Japan."

Dr. Roland du Bois, Professor of Medicine at National Jewish Health, Denver, Colo., and CAPACITY co-chair also commented on the CAPACITY results. "When taken in the context of the urgent unmet medical need for new medicines to treat IPF patients, the collective efficacy and safety data from the two CAPACITY studies, corroborated by a similar study in Japan, make a case for the use of pirfenidone in this disease setting."

Primary Efficacy Endpoint Results

The primary endpoint of both CAPACITY studies was change in percent predicted Forced Vital Capacity (FVC) after 72 weeks of treatment, evaluated with a nonparametric rank ANCOVA. In the CAPACITY 2 study, the primary endpoint was met (p=0.001). In CAPACITY 1, the primary endpoint was not met (p=0.501). An exploratory analysis of pooled primary endpoint data from both studies using the pre-specified primary endpoint test statistic from a nonparametric rank ANCOVA resulted in a P value of 0.005.

A pre-specified repeated measures analysis of the primary endpoint was used to obtain a least squares mean estimate (LS mean) of the magnitude of the treatment effect. The LS mean change in percent predicted FVC at Week 72 was -6.5% and -9.6% in the pirfenidone and placebo groups, respectively, in CAPACITY 2, and -6.5% and -7.2%, respectively, in CAPACITY 1. This represents
'/>"/>

SOURCE InterMune, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12

Related medicine technology :

1. Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms
2. Optimer Pharmaceuticals Presents Results From Fidaxomicin Phase 3 Study for the Treatment of Clostridium difficile Infection
3. BioVex to Report Phase I/II Clinical Trial Results for the Front Line Treatment of Head and Neck Cancer With OncoVEX GM-CSF at the 2009 American Society of Clinical Oncology Meeting
4. TYRX Presents Early Clinical Results from AIGISRX(TM) Antibacterial Envelope Retrospective Registry
5. Metabolic Solutions Development Company Announces Preliminary Results from Phase IIa Clinical Trial
6. AlphaVax Announces Promising Results in Melanoma Studies
7. Ongoing Landmark ROADMAP Study Demonstrates Significant Improvement in Blood Pressure Control at One Year, According to Blinded Results
8. BioCryst Provides Peramivir Update and Reports First Quarter 2009 Financial Results
9. Bionovo Announces First Quarter 2009 Highlights and Financial Results
10. Alexza Reports 2009 First Quarter Financial Results and Updates Clinical Pipeline Status
11. ADVENTRX Announces Results From ANX-514 Bioequivalence Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... , Sept. 19, 2014 Medical science ... relationships with key opinion leaders (KOLs) who can ... Despite the critical nature of the MSL function, ... including altering the landscape for creating and maintaining ... to research, the oversight responsibility for the MSL ...
(Date:9/19/2014)... 2014  Today DePuy Synthes Companies of Johnson ... systems featuring its proprietary variable angle locking technology. ... to match patient anatomy and fracture pattern and ... systems are being introduced in conjunction with the ... the International Federation of Foot & Ankle Societies ...
(Date:9/19/2014)... , Sept. 19, 2014 /PRNewswire-iReach/ -- ... Oxybutynin Hydrochloride Industry, 2009-2019 is a professional ... Chinese Oxybutynin Hydrochloride industry. The report firstly ... including its classification, application and manufacturing technology. ... top manufacturers of Oxybutynin Hydrochloride listing their ...
Breaking Medicine Technology:Role of Medical Science Liaisons Shifting in Healthcare Industry 2DePuy Synthes Proprietary Variable Angle Locking Technology Now Available To Treat Calcaneal Fractures And Medial Column Fusion Procedures 2DePuy Synthes Proprietary Variable Angle Locking Technology Now Available To Treat Calcaneal Fractures And Medial Column Fusion Procedures 3Oxybutynin Hydrochloride Industry 2014-2019 Chinese Forecasts & Analysis 2Oxybutynin Hydrochloride Industry 2014-2019 Chinese Forecasts & Analysis 3Oxybutynin Hydrochloride Industry 2014-2019 Chinese Forecasts & Analysis 4Oxybutynin Hydrochloride Industry 2014-2019 Chinese Forecasts & Analysis 5
... Sept. 21, 2011 Mylan Inc. (Nasdaq: ... a settlement and license agreement with Hoffman La Roche ... and 500 mg, USP, known generically as Capecitabine Tablets. ... in the treatment of metastatic breast and colorectal cancers. ...
... At Home Healthcare, a leading provider of home ... with Cardiocom to provide advanced home telehealth technology to ... a world class developer, manufacturer and clinical service provider ... to provide superior home care and to ensure the ...
Cached Medicine Technology:Mylan Announces XELODA® Settlement and License Agreement 2At Home Healthcare Expands Telehealth Program With Cardiocom® Telehealth Technology 2
(Date:9/21/2014)... PA (PRWEB) September 21, 2014 "I ... their legs and back but haven’t the money for ... I’d like to have such a product for myself." ... effective way to stretch the thigh muscles and align ... as well as relieves discomfort of pinched nerves. Compact ...
(Date:9/21/2014)... Best Cheap Hosting USA, one of ... Bluehost and GreenGeeks are the best Reseller hosting suppliers ... reseller hosting supplier. Actually, these companies have outperformed their ... support. People can get the best web hosting at ... According to the manager, reseller hosting is a very ...
(Date:9/21/2014)... (PRWEB) September 21, 2014 To accommodate ... e-powered platform and provide more trendy items. Recently, the ... . By offering the new and elegant wedding gowns, ... get what they need in an easy way. Its ... deeply discounted rates, from 12% off to 62% off. ...
(Date:9/21/2014)... 21, 2014 “Cluster headaches are sometimes ... and difficult to resolve,” said Steve Young of Ew ... of a pain that is more intense.” , “It ... cluster headaches, or migraines, that medical research is pointing ... system,” he added. , Serotonin (5-HT, 5-hydroxytryptamine) is a ...
(Date:9/21/2014)... C8 lawsuits move forward in the ... list of 20 possible C8 lawsuits selected for ... reports Wright & Schulte LLC. Court records show these ... C8 lawsuits filed that represent individuals who purportedly developed ... result of being exposed to water contaminated by the ...
Breaking Medicine News(10 mins):Health News:Best Cheap Hosting USA Announces The Best Reseller Hosting Suppliers In 2014 2Health News:Angeldress.co.uk Launches New Range Of 2014 Vintage Wedding Dresses In Its Online Store 2Health News:Homeostasis: Equinox Serotonin (5HT) Headache Stories ~ New on the Bryan William Brickner Blog 2Health News:C8 Lawsuit Claims Move Forward as Six Possible Cases for Bellwether Trials Selected in DuPont Water Contamination Lawsuits, Reports Wright & Schulte LLC 2Health News:C8 Lawsuit Claims Move Forward as Six Possible Cases for Bellwether Trials Selected in DuPont Water Contamination Lawsuits, Reports Wright & Schulte LLC 3Health News:C8 Lawsuit Claims Move Forward as Six Possible Cases for Bellwether Trials Selected in DuPont Water Contamination Lawsuits, Reports Wright & Schulte LLC 4
... Washington Teenage girls are setting new trends in drug ... , a report has shown. ,Teen boys have ... Wanting a slice of the vice, teen girls have become ... drugs, according to the White House Office of National Drug ...
... finds that sleep deprivation can adversely affect a persons ... of gains and making light of ones losses ... neural underpinnings of risky decision making under conditions of ... studied healthy volunteers as they underwent functional magnetic resonance ...
... not get training posts through the flawed Medical Training ... government is stalling on a new contract for ... figures show that 34,250 doctors are chasing 18,500 specialist ... far given no commitment that trainee doctors will be ...
... definite link between pregnancy, migraine and stroke, US researchers ... one. ,In fact, Cheryl Bushnell, assistant professor ... Disease in Durham, explained that pregnant women who suffered ... than pregnant women who did not suffer migraine. ...
... Science & Technology, Government of India and the ... today to address a major obstacle in AIDS ... elicit neutralizing antibodies against HIV. A new Indian ... and the Department of Biotechnology, will comprise top ...
... disturbing link between Reclast, made by Novartis AG and Fosamax manufactured ... in a small number of women users. Both are known bone-building ... more pronounced with Reclast, given as an annual shot. But there ... took the leading osteoporosis pill, Fosamax by Merck & Co. They ...
Cached Medicine News:Health News:Sleep Deprivation can Affect Competent Decision-making 2Health News:Junior Doctors Facing More Misery Because of Contract Deadlock: BMA 2Health News:DBT And IAVI Forge Partnership To Develop Next Generation Vaccine Candidates 2Health News:DBT And IAVI Forge Partnership To Develop Next Generation Vaccine Candidates 3Health News:Anti-osteoporosis Drugs Could Result in Irregular Heart Rhythm, New Study 2
... care management tools that support the nursing ... vital signs and I&O information at the ... on-line flow sheets. This design supports compliance ... the hall, or at the nursing station, ...
For superior bar code scanning performance with maximum user comfort at a highly attractive price, the LS 4000i Scanner Series from Symbol Technologies establishes an award-winning standard of excell...
... latex-free, thermal transfer wristband for printing ... images that resist smears and abrasion ... cleaners, and blood. A time-tested and ... patron management applications. A tamper-evident VOID ...
... The DataMate Laser ... System consists of laser-printable ... closure wristband and laser ... paperwork. The wristbands clear, ...
Medicine Products: