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:8/27/2015)... , Aug. 27, 2015 Major pharmaceutical and medical ... a legal conference in Philadelphia on ... issues, Tom Hagy of HB Litigation Conferences has ... visit HB,s website at http://litigationconferences.com/?p=31886 The ... McCambridge Singer & Mahoney and Michelle Hart Yeary ...
(Date:8/27/2015)... Aug. 27, 2015  PinnacleHealth CardioVascular Institute enrolled the first ... the United States in a trial ... stent for blockages in the main artery of the leg. ... and potentially less risk for stent fracture or re-narrowing after ... single-arm, multicenter clinical trial of the BioMimics 3D Stent System ...
(Date:8/27/2015)... 27, 2015 The Elekta Linac-based ... Boston on July 9th for its ... to more fully exploit the potential of advances in ... diseases. "As an established provider of sophisticated ... assume a leadership role - in collaboration with its ...
Breaking Medicine Technology:Pharmaceutical, Medical Device Law Seminar Features In-House, Outside Counsel 2Pharmaceutical, Medical Device Law Seminar Features In-House, Outside Counsel 3First Pennsylvania Patient Treated in Landmark Vascular Study 2New Elekta Consortium to Push Frontiers of Linear Accelerator-Based Stereotactic Radiation Therapy for the Brain 2New Elekta Consortium to Push Frontiers of Linear Accelerator-Based Stereotactic Radiation Therapy for the Brain 3
(Date:8/27/2015)... ... ... In an article published July 30th by the New York Times, ... a security firm that is tasked with providing supplemental protection. Called the French Quarter ... the city to provide private security when it is needed in a city that ...
(Date:8/27/2015)... ... August 27, 2015 , ... About ... Katrina slammed into the Gulf Coast, killing more than 1,800 people, displacing hundreds ... to a Georgia State University study. , While most people don’t develop persistent ...
(Date:8/27/2015)... ... August 27, 2015 , ... Healthpointe is proud to welcome Dr. Ted ... Los Angeles. Licensed to practice Chinese Needle Therapy since 1983, Dr. Priebe specializes in ... Dr. Priebe also practices in Healthpointe’s La Mirada clinic and Garden Grove clinic. ...
(Date:8/27/2015)... ... August 27, 2015 , ... ... and leading biopharmaceutical contract development manufacturing company (CDMO), announced today that it has ... for $205.68M in cash. , The addition of Cytovance Biologics to ...
(Date:8/27/2015)... ... ... King Kullen, America’s First Supermarket, is celebrating 85 years of serving the ... recognized by the Smithsonian Institute as America’s First Supermarket, King Kullen changed the grocery ... Kennedy families have created a culture of caring while building their business. Offering ...
Breaking Medicine News(10 mins):Health News:Article on New Orleans Security Force Highlights the Abilities and Flexibility of Private Security, says Spear Security Inc. 2Health News:About 10 Percent of Mothers Experienced Depression Two Years After Hurricane Katrina, New Study Shows 2Health News:Qualified Medical Examiner and Acupuncturist Joins Healthpointe in Los Angeles 2Health News:Qualified Medical Examiner and Acupuncturist Joins Healthpointe in Los Angeles 3Health News:Great Point Partners, LLC Announces that Hepalink USA Inc. Agrees to Acquire Cytovance Biologics, Inc. 2Health News:Great Point Partners, LLC Announces that Hepalink USA Inc. Agrees to Acquire Cytovance Biologics, Inc. 3Health News:Great Point Partners, LLC Announces that Hepalink USA Inc. Agrees to Acquire Cytovance Biologics, Inc. 4Health News:King Kullen Honors Their 85 Years of Success this August 2
... vaccines for new flu strains, other health threats ... Researchers have devised a rapid and efficient method ... called monoclonal antibodies, which mark and neutralize foreign ... accelerate the traditionally challenging task of generating human ...
... Healed by Registered Organ and Tissue Donors, ... tissue donors joined organ transplant recipients at the ... the Department of Motor,Vehicles (DMV) and the three ... lives by signing up on the state-authorized Donate ...
... healthy,eating and neonatal jaundice are among the many topics ... the upcoming Pediatric,Academic Societies Meeting in Honolulu May 2-6. ... more information or to reach one of,the researchers, call ... **ALL RESEARCH IS EMBARGOED UNTIL THE DATE AND TIME ...
... JOLLA, CA Diabetic individuals have a significantly ... molecular connection between the two remains unexplained. Now, ... identified the probable molecular basis for the diabetes ... in the current online issue of Neurobiology of ...
... from Allscripts Document Management; Expects ... Clinical & Financial Investment, CHICAGO and FORT ... of clinical software, connectivity and,information solutions that physicians ... Center Medical Group has selected the Allscripts,Electronic Health ...
... Fall Out Boy, Will.i.am, Alyssa Milano, Say Anything,Perez ... Helping Fuel,Game,s Viral Spread, Developed in Partnership ... Personal Stories of Americans Living With and Without,HIV/AIDS, ... Peabody and,Emmy Award-winning college network, and the Kaiser ...
Cached Medicine News:Health News:Researchers Develop Quick Way to Create Human Antibodies 2Health News:Researchers Develop Quick Way to Create Human Antibodies 3Health News:Three Million Californians Say 'Yes!' to Organ and Tissue Donation 2Health News:Three Million Californians Say 'Yes!' to Organ and Tissue Donation 3Health News:New Research From Packard Children's Hospital Experts Presented at 2008 Pediatric Academic Societies' Annual Meeting 2Health News:New Research From Packard Children's Hospital Experts Presented at 2008 Pediatric Academic Societies' Annual Meeting 3Health News:New Research From Packard Children's Hospital Experts Presented at 2008 Pediatric Academic Societies' Annual Meeting 4Health News:Salk study links diabetes and Alzheimer's disease 2Health News:Salk study links diabetes and Alzheimer's disease 3Health News:The Heart Center Selects Allscripts Electronic Health Record and Practice Management for 50 Physicians 2Health News:The Heart Center Selects Allscripts Electronic Health Record and Practice Management for 50 Physicians 3Health News:The Heart Center Selects Allscripts Electronic Health Record and Practice Management for 50 Physicians 4Health News:mtvU & Kaiser Family Foundation Launch POSorNOT.com to Challenge Stigma, Fight Spread of HIV/AIDS 2Health News:mtvU & Kaiser Family Foundation Launch POSorNOT.com to Challenge Stigma, Fight Spread of HIV/AIDS 3Health News:mtvU & Kaiser Family Foundation Launch POSorNOT.com to Challenge Stigma, Fight Spread of HIV/AIDS 4Health News:mtvU & Kaiser Family Foundation Launch POSorNOT.com to Challenge Stigma, Fight Spread of HIV/AIDS 5Health News:mtvU & Kaiser Family Foundation Launch POSorNOT.com to Challenge Stigma, Fight Spread of HIV/AIDS 6
Solid State Manometry Catheter Accessory., ,Manometric calibrators are required for calibration of solid state catheters., ,Each type of catheter requires a unique calibrator....
Sphincter of Oddi Solid State Catheter Adapter Cable for Polygraf ID...
... 3 system consists of the Model 7432 ... MemoryMod Software Cartridge. , ,Enterra™ Therapy ... nausea and vomiting associated with gastroparesis when ... relief of symptons for diabetic or idiopathic ...
... Intramuscular Lead is a unipolar lead intended for ... has a ski needle design for easier use ... a fixed electrode length of 1 cm. The ... is available in 35 cm length. Two leads ...
Medicine Products: