Navigation Links
InterMune Reports Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF
Date:2/3/2009

first 48 weeks of treatment. For example, in CAPACITY 2 and CAPACITY 1 the Week 48 rank ANCOVA p values were 0.001 and 0.005; the relative reductions in LS means from the repeated measures analysis were 46% and 29%, respectively. The difference between the CAPACITY 2 and CAPACITY 1 primary endpoint results at Week 72 may have been due to a modest attenuation in the rate of FVC decline in the placebo group subsequent to Week 48 in CAPACITY 1.

Secondary Endpoint Results

In CAPACITY 2, pirfenidone treatment was associated with a statistically significant effect on the pre-specified secondary endpoints of PFS (p = 0.023) and Categorical Change in FVC (p = 0.001) when compared to placebo. A PFS event was defined in the study protocol as the time to death, a 10% decrease in FVC or a 15% decrease in DL(CO). In CAPACITY 1, pirfenidone treatment was associated with a statistically significant effect in the pre-specified secondary endpoint of Six-Minute Walk Test distance (p = 0.001) when compared to placebo. There were no other statistically significant findings on any of the other pre-specified secondary endpoints in either study and pirfenidone treatment was not associated with a worse outcome on any endpoints.

Although pooled analyses of secondary endpoints were pre-specified in the study protocol, these analyses are nonetheless considered exploratory because the primary endpoint of both studies was not met. Analyses of pooled data for the pre-specified secondary endpoints of both CAPACITY studies showed a treatment effect favoring pirfenidone on three: PFS (p = 0.029); Categorical FVC Change (p = 0.003) and Six-Minute Walk Test distance (p = 0.004). While the studies were not powered to demonstrate an effect on overall survival, the pooled hazard ratio (pirfenidone: placebo) was 0.78 (p= 0.326).

Safety and Tolerability Results

Safety data from both studies show that pirfenidone wa
'/>"/>

SOURCE InterMune
Copyright©2009 PR Newswire.
All rights reserved

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

Related biology technology :

1. InterMune to Present at J.P. Morgan Healthcare Conference
2. InterMune to Present at Deutsche Bank Biotech Boston Confab
3. InterMune Reports Third Quarter 2008 Financial Results and Business Highlights
4. InterMune to Release Third Quarter 2008 Financial Results on November 6
5. InterMune Reports Japanese Regulatory Approval of Pirfenidone in IPF
6. InterMune to Present Four Abstracts on HCV Protease Inhibitor ITMN-191 at the AASLD Meeting
7. InterMune Earns Development Milestone in HCV Protease Inhibitor Collaboration With Roche
8. InterMune to Present at Canaccord Adams Conference
9. InterMune Reports Second Quarter 2008 Financial Results and Business Highlights
10. InterMune to Present at BMO Healthcare Conference
11. InterMune to Release Second Quarter 2008 Financial Results and Provide Business Update on July 31
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/30/2014)... 30, 2014 James Sherley says he has ... tissue stem cell technology since his days as a principal ... in the late 1990’s. Sherley founded the ASCTC as ... holds all the intellectual property developed in Sherley’s research over ... Massachusetts Institute of Technology (MIT), and more recently as a ...
(Date:10/30/2014)... Erlanger, Kentucky (PRWEB) October 30, 2014 Avure ... of the 525L, the newest member of its fleet of ... to be reaching an anniversary as we return to PackExpo ... a year ago in Las Vegas,” said Jeff Williams, CEO ... extremely well, and we’re pleased to be meeting the challenges ...
(Date:10/30/2014)... 2014 A new report, commissioned by BioCrossroads ... an in-depth look at Indiana,s ... over two different time frames: 1993 to 2002 and ... future opportunities for investment growth.  The Life Science ... report shows gains in innovation dollars as well as an ...
(Date:10/30/2014)... The severe flooding that devastated a wide swath of ... the bridges, roads and other infrastructure had been upgraded ... University of Colorado Denver. , "People need to understand ... PhD, associate professor of structural engineering at the CU ... author the study. "There is an assumption that a ...
Breaking Biology Technology:Boston’s Adult Stem Cell Technology Center, LLC Introduces A New Technology for Monitoring Previously Elusive Adult Stem Cells 2Boston’s Adult Stem Cell Technology Center, LLC Introduces A New Technology for Monitoring Previously Elusive Adult Stem Cells 3Boston’s Adult Stem Cell Technology Center, LLC Introduces A New Technology for Monitoring Previously Elusive Adult Stem Cells 4In High Demand: New High Pressure Processing (HPP) System with Maximum Throughput Drives Strong Sales 2In High Demand: New High Pressure Processing (HPP) System with Maximum Throughput Drives Strong Sales 3New report shows Indiana's gains in life sciences innovation capital outpace the nation 2New report shows Indiana's gains in life sciences innovation capital outpace the nation 3New report shows Indiana's gains in life sciences innovation capital outpace the nation 4New report shows Indiana's gains in life sciences innovation capital outpace the nation 5CU Denver study says upgrading infrastructure could reduce flood damage 2
... done and now they,ve done it. What,s more, they did ... U.S. Department of Energy (DOE),s Lawrence Berkeley National Laboratory (Berkeley ... the first experimental demonstration of GRIN for gradient index ... a wide range of exotic optics, including superfast computers based ...
... 2011 Amgen (Nasdaq: AMGN ) and ... into a definitive acquisition agreement under which Amgen has ... venture-funded,  biotechnology company headquartered in Woburn, Mass. BioVex is ... Phase 3 clinical development, that may represent a new ...
... (Nasdaq: CEPH ) will hold a public memorial service ... and CEO on February 1, 2011, at 6:00 p.m. at The ... Dr. Baldino founded Cephalon in 1987 and led the ... ten biotechnology companies in the world. He was a recognized pioneer ...
Cached Biology Technology:GRIN plasmonics 2GRIN plasmonics 3GRIN plasmonics 4Amgen to Acquire BioVex, a Privately Held Biotechnology Company Headquartered in Woburn, Mass 2Amgen to Acquire BioVex, a Privately Held Biotechnology Company Headquartered in Woburn, Mass 3Amgen to Acquire BioVex, a Privately Held Biotechnology Company Headquartered in Woburn, Mass 4Amgen to Acquire BioVex, a Privately Held Biotechnology Company Headquartered in Woburn, Mass 5Amgen to Acquire BioVex, a Privately Held Biotechnology Company Headquartered in Woburn, Mass 6Amgen to Acquire BioVex, a Privately Held Biotechnology Company Headquartered in Woburn, Mass 7Cephalon to Hold Public Memorial Service to Celebrate the Life of Company Founder, Frank Baldino, Jr., Ph.D. 2
(Date:10/29/2014)... both genetic and environmental, have been blamed for ... Some, such as a family history of schizophrenia, ... Toxoplasma gondii , a parasite transmitted by ... viewed with skepticism. , A new study by ... at the University of Pennsylvania,s School of Veterinary ...
(Date:10/29/2014)... household and industrial products are in the environment – ... of them, scientists have yet to determine whether they ... toward doing that by estimating which substances people are ... in the ACS journal Environmental Science & Technology ... the risks to human health of any given substance ...
(Date:10/29/2014)... held in New York City on September 19, 2014, ... Cancer Society Professor of Genome Sciences and Medicine at ... Doctor of Philosophy of Tel Aviv University, was awarded ... , In addition to her honorary degree from TAU, ... TAU School of Medicine, and for the past 18 ...
Breaking Biology News(10 mins):Penn vet professor investigates parasite-schizophrenia connection 2Penn vet professor investigates parasite-schizophrenia connection 3Geneticist and humanitarian: Prof. Mary-Claire King receives Lasker Award 2
... and U.S. Department of Agriculture should jointly establish a ... the effectiveness of actions meant to improve water quality ... Gulf of Mexico, says a new report from the ... to move forward on the larger process of allocating ...
... Throughout history, human beings have used the whistle for everything ... orangutan,s spontaneous whistling is providing scientists at Great Ape Trust ... learning. In a paper published this month in Primates ... on all aspects of primates in relation to humans and ...
... could lead to a radical re-thinking about how the ... "Six of the adult females that we followed in ... out on the Arctic sea ice," said Universit Laval ... Gilles Gauthier as part of an International Polar Year ...
Cached Biology News:EPA and USDA should create new initiative to better monitor nutrients 2EPA and USDA should create new initiative to better monitor nutrients 3EPA and USDA should create new initiative to better monitor nutrients 4Orangutan's spontaneous whistling opens new chapter in study of evolution of speech 2Orangutan's spontaneous whistling opens new chapter in study of evolution of speech 3Snowy owl -- a marine species? 2
... Formula variant: With the ... described by Hoagland and ... Equivalency: Formulated to contain ... powder per liter of ...
... separation and fractionation of nucleic-acid ... nuclei from cytosolic proteins A ... greatly facilitating study of low-abundance ... acid binding proteins (e.g., transcription ...
... Eagle's medium have been developed ... most widely used modification is ... a modification of Minimum Essential ... a higher concentration of vitamins ...
... EpiTect Bisulfite Kit enables complete conversion ... less than 6 hours. The highly ... against DNA degradation and a spin-column-based ... fast and reliable results for all ...
Biology Products: