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

dy, the compelling safety and tolerability profile observed in CAPACITY, together with the urgent unmet medical need for new medicines to treat IPF strongly support our decision to move forward with our NDA and an MAA submissions for pirfenidone as soon as possible. IPF is a disease that is more lethal than almost every form of cancer, affects almost 250,000 Americans and Europeans combined, and for which there are no medicines approved for their treatment."

Primary 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 a relative reduction of 32% in CAPACITY 2 and 10% in CAPACITY 1.

To better understand the primary efficacy outcome, InterMune conducted a series of exploratory analyses interrogating the time course of treatment effect. An exploratory repeated measures analysis of ranked change from baseline, assessing treatment effect over the full duration of the study suggested pirfenidone reduced the decline in FVC in both studies (CAPACITY 2 p = 0.004 and CAPACITY 1 p = 0.001). In both studies, the magnitude of treatment effect generally was most pronounced in the
'/>"/>

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:7/24/2014)... materialise. Yet, scientists are making progress in devising ... such approach relies on quantum dotsa kind of ... field. A new study demonstrates that changing the ... with electrical impulses can help better control them. ... used as quantum information units, which would produce ...
(Date:7/24/2014)... 24, 2014 Research and Markets ... and Proteomics Analytical Instruments Market 2014-2018" report to ... Genomics is the study of the gene ... the structure and functions of proteomes or sets of ... technology. Genomics involves the mapping of genes and DNA ...
(Date:7/24/2014)... San Francisco, CA (PRWEB) July 24, 2014 ... Wednesday to be semi-finalists in Livestrong’s Big C Competition. ... Decisive Health are each headed to the semi-final round. ... in Livestrong’s exclusive three-month accelerator program, complete with mentoring ... country. , As part of the angelMD commitment ...
(Date:7/24/2014)... July 24, 2014 1000 balances – ... input on customers’ weighing needs and expertly narrows down ... of balances, scales or even terminals. , First, ... smallest weight (or select readability instead) and define the ... additional selection criteria narrows down the list to models ...
Breaking Biology Technology:Global Genomics and Proteomics Analytical Instruments Market 2014-2018: Key Vendors are Agilent, Bio-Rad , F. Hoffmann, La Roche, Illumina, PerkinElmer and Thermo Fisher Scientific 23 angelMD Startups Make Livestrong Big C Semi-finals 2
... Site, ST. LOUIS, Sept. 26 ... SIAL ), has announced a $29 ... capabilities in,high-potency biologics at the Sigma-Aldrich facility ... SAFC Pharma(TM) to provide process,development and cGMP ...
... 26 PAREXEL International,Corporation (Nasdaq: PRXL ... announced the successful completion of the acquisition,of ... ("APEX") in,a separate press release. In conjunction ... the Company is updating its forward-looking,financial guidance ...
... Inc.,(Nasdaq: ITMN ) today announced that it ... stock at a price to the public of ... representing the exercise,by the underwriters of their option ... proceeds to the company of the offering are ...
Cached Biology Technology:SAFC to Expand High-Potency API Fermentation Capabilities 2SAFC to Expand High-Potency API Fermentation Capabilities 3PAREXEL International Updates Financial Guidance in Conjunction with the Acquisition of APEX International Clinical Research Co., Ltd. and Other Factors 2PAREXEL International Updates Financial Guidance in Conjunction with the Acquisition of APEX International Clinical Research Co., Ltd. and Other Factors 3PAREXEL International Updates Financial Guidance in Conjunction with the Acquisition of APEX International Clinical Research Co., Ltd. and Other Factors 4InterMune Announces Closing of Public Offering of Common Stock 2
(Date:7/24/2014)... in humans, affect the connections between nerve cells and ... an area of the brain that plays a significant ... The results of the study have been published in ... on the active communication between nerve cells, known as ... a dense network where they constantly relay signals to ...
(Date:7/24/2014)... of biodiversity and one of the most species richness ... world. However, current levels of diversity might be still ... increase in the description of new endemic species of ... and availability of samples for DNA analysis. , ... and morphological analysis, researchers from the University of ...
(Date:7/24/2014)... Mass. (July 24, 2014) For years, researchers and ... forming nearly any cell type in the bodycould provide ... treat them. Yet progress has been hampered by the ... studies to their human counterparts, in part because human ... mouse cells. , Now Thorold Theunissen, Benjamin Powell, and ...
Breaking Biology News(10 mins):A protein couple controls flow of information into the brain's memory center 2A protein couple controls flow of information into the brain's memory center 3A protein couple controls flow of information into the brain's memory center 4A tiny new species of frog from Brazil with a heroic name 2Whitehead Institute researchers create 'naïve' pluripotent human embryonic stem cells 2
... Motor Neurone Disease Association is funding its first ever ... of this fatal, neurological condition. Pulling together ... and Prof Sir Ian Wilmut from the University of ... Prof Tom Maniatis of Columbia University New York; the ...
... "mineral-breathing" bacteria found in many oxygen-free environments may be ... microbes sometimes described as "mineral-breathing" because they use iron ... use oxygen. According to a study published online May ... bacterial respiration may be accelerated by solid organic compounds ...
... WALL, N.J. , May 5 BIO-key International, Inc. (OTC ... BIO-key will be presenting at the Annual SafeTrace User Group Meeting being held ... Lake City, Utah . , , ... http://www.newscom.com/cgi-bin/prnh/20050509/BIOKEYLOGO ) , , , ...
Cached Biology News:Harnessing the power of stem cells to unlock the secrets of motor neuron disease 2Harnessing the power of stem cells to unlock the secrets of motor neuron disease 3Harnessing the power of stem cells to unlock the secrets of motor neuron disease 4Organic solids in soil may speed up bacterial breathing 2BIO-key(R) International Invited to Speak at Annual SafeTrace(R) User Group Meeting 2
... Microarrays designed for genome-wide microRNA expression ... and powerful Paraflo microfluidic on-chip synthesis ... part of our comprehensive microRNA Expression ... The Arabidopsis microRNA Microarray contains ...
... genome-wide microRNA expression profiling and built ... microfluidic on-chip synthesis platform. These microarrays ... comprehensive microRNA Expression Profiling Service. ... microRNA Microarray contains all known maize ...
...
... At the forefront of Agilent analytical ... Built-in local area networking (LAN) allows you ... sites--for fast and informed decision making. Just ... has all the flexibility and performance needed ...
Biology Products: