Navigation Links
Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients
Date:5/21/2013

ORLANDO, Fla., May 21, 2013 /PRNewswire/ -- Janssen R&D Ireland (Janssen) today announced primary efficacy and safety results from the global Phase 3 PROMISE study demonstrating that use of the investigational protease inhibitor simeprevir (TMC435) led to sustained virologic response 12 weeks after the end of treatment (SVR12) in 79 percent of treatment-experienced genotype 1 chronic hepatitis C adult patients with compensated liver disease, including all stages of liver fibrosis, when administered once daily with pegylated interferon and ribavirin.

In the study, 37 percent of patients receiving placebo plus pegylated interferon and ribavirin achieved SVR12. In the simeprevir arm, on-treatment failure rates were 3 percent and relapse rates were 19 percent, compared to 27 percent and 48 percent in the placebo arm. All patients had previously relapsed following pegylated interferon-based therapy. The data were presented today as a late breaker oral presentation at Digestive Disease Week 2013 in Orlando, Florida based on abstract number 869b, "Simeprevir (TMC435) With Peginterferon/Ribavirin for Treatment of Chronic HCV Genotype 1 Infection in Patients Who Relapsed After Previous Interferon-Based Therapy: Results From PROMISE, a Phase III Trial."

"Hepatitis C is a complex disease and physicians need multiple treatment options to provide their patients the best possible chance at successful therapy," said Eric Lawitz , M.D., professor of medicine at University of Texas Health Science Center, Vice President, scientific and research development, The Texas Liver Institute and principal investigator of the PROMISE trial. "I'm pleased that the primary efficacy and safety results from the PROMISE study of simeprevir show sustained virologic response in patients who had relapsed following previous treatment with interferon-based regimens."

In PROMISE, patients we
'/>"/>

SOURCE Janssen R&D Ireland
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. PharmacyGPO Buying Group Selects H. D. Smith as Primary National Distributor
2. Phase 3 MISSION trial of Nexavar (sorafenib) in Patients with Non-Small Cell Lung Cancer Did Not Meet Primary Endpoint of Improving Overall Survival
3. Healthscope to commercially launch Circadians Cancers of Unknown Primary Diagnostic Test
4. Medical Oncology Association of Southern California Purchasing Network (MPN) Names Cardinal Health Specialty Solutions as its Primary Healthcare Solutions Partner
5. Lilly Announces Pomaglumetad Methionil Did Not Meet Primary Endpoint of Clinical Study
6. Jeffrey Modell Foundation Opens Diagnostic Center for Primary Immunodeficiencies at Midwest Immunology Clinic
7. MultiCell Technologies Updates Preclinical Results for MCT-465 and MCT-485 in Primary Liver Cancer in vitro Models
8. GeneTex, Inc. to Launch a New Primary Antibody against HIF1a
9. Albireo Has Been Granted Orphan Drug Designation for A4250 from the US FDA for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) and for Primary Biliary Cirrhosis (PBC)
10. AcelRx Announces Achievement of the Primary End-Point in Phase 3 Comparative Study Involving the Sufentanil NanoTab PCA System and Plans to Hold a Conference Call and Webcast Tomorrow to Discuss Top-Line Results
11. Phase II Trial of Sanofi JAK2 Inhibitor in Myelofibrosis Met Primary Endpoint
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/26/2015)... GLEN BURNIE, Md. , Feb. 26, 2015 ... patient recruitment solutions for the clinical research industry, ... Karen Welch as a Project Manager, ... Team. Photo - http://photos.prnewswire.com/prnh/20150225/177750 ... Project Manager with a demonstrated ability to successfully ...
(Date:2/26/2015)... VIEW, Calif. , Feb. 26, 2015 ... sector, giving birth to effective, inexpensive and ... encouraged researchers to build small-scale, potent devices, ... Logo - http://photos.prnewswire.com/prnh/20150225/177944LOGO ... & Sullivan, Innovations in Nanomanufacturing, finds that ...
(Date:2/26/2015)... , Feb. 26, 2015   Coverall North ... franchised businesses, today celebrates 30 Years of Clean, a ... anniversary. Coverall started in 1985 as a ... and is now a leading global brand ... Coverall,s passion and mission have remained consistent: To promote ...
Breaking Medicine Technology:CSSi's Continued Growth Brings Talented New Hire - Karen Welch Welcomed as Project Manager 2Revolutionary Nanomanufacturing Technology to Approach Commercialization by 2020 2Revolutionary Nanomanufacturing Technology to Approach Commercialization by 2020 3Revolutionary Nanomanufacturing Technology to Approach Commercialization by 2020 4Coverall Celebrates 30 Years of Clean 2Coverall Celebrates 30 Years of Clean 3
(Date:2/26/2015)... Catalent Pharma Solutions, the ... and development solutions for drugs, biologics and ... expanded capabilities within its European Clinical Supply ... in response to increased customer demand for ... highly-potent or temperature-sensitive investigational medical products continues ...
(Date:2/26/2015)... February 26, 2015 A Beautiful Smile ... practice is offering the following 50 year celebration specials ... their choice of Sonic Care Diamond Clean or the ... respectively). The cost is $2895 for the Invisalign ... more than ten treatment procedures are priced accordingly). ...
(Date:2/26/2015)... 26, 2015 Software and Cybersecurity ... Position and Best Practices for Compliance, **Presented by ... MD, http://www.fdanews.com/SoftwareAndCybersecurity , This workshop — ... has been specifically designed to provide attendees with ... assure medical device software safety. , In fact, ...
(Date:2/26/2015)... Linda, CA (PRWEB) February 26, 2015 ... , “Diversity of extracellular vesicles and their cargo in ... extracellular vesicles and their relevance for cell-to-cell communication. The ... live March 4, 2015 at 8:00am PT. , Every ... extracellular vesicles (EVs) , often called “exosomes” or ...
(Date:2/26/2015)... Kantar Health UK, a leading global healthcare consulting ... Companies to Work For” list for 2015. This was the ... list, which measures employees’ levels of fulfilment, motivation and engagement. ... UK, and we are delighted to be included in this ... said. “The team is dedicated to putting clients first. We ...
Breaking Medicine News(10 mins):Health News:Catalent Expands European Clinical Packaging Capabilities, Highlighting Growing Industry Need for Specialty Handling 2Health News:Catalent Expands European Clinical Packaging Capabilities, Highlighting Growing Industry Need for Specialty Handling 3Health News:A Beautiful Smile Dentistry is Celebrating 50 Years in Practice! 2Health News:A Beautiful Smile Dentistry is Celebrating 50 Years in Practice! 3Health News:FDAnews New Workshop — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, April 14-15 2Health News:FDAnews New Workshop — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, April 14-15 3Health News:FDAnews New Workshop — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, April 14-15 4Health News:Beckman Coulter Webinar Series Presents Diversity of Extracellular Vesicles and Their Cargo in Cell-to-cell Communication 2Health News:Beckman Coulter Webinar Series Presents Diversity of Extracellular Vesicles and Their Cargo in Cell-to-cell Communication 3Health News:Kantar Health UK Named One of The Sunday Times 100 Best Small Companies to Work For 2
... Jan. 7 Insulet Corporation (Nasdaq: PODD ... OmniPod(R) Insulin Management System, today announced the company will ... Management is scheduled to present an overview of the ... at The Westin St. Francis in San Francisco, CA.During ...
... Beneficiaries Introduced on the First Day of 111th ... Physical therapy services for Medicare beneficiaries would ... under legislation introduced Tuesday in the Senate and ... Therapy Association (APTA). The Medicare Access to Rehabilitation ...
... a statement by Lois Aronstein, AARP NY State Director:Governor ... recommendations on a number of issues that are essential ... Yorkers of all ages.AARP commends the Governor for proposing ... percent of the federal poverty level, making more than ...
... have identified mutations in a gene that predict a ... leukemia (ALL). Although the researchers caution that further research ... called IKZF1 or IKAROS, lead to leukemia relapse, the ... diagnostic tests to assess the risk of treatment failure. ...
... SYK ) announced today that it will participate in the following ... January 14, 2009 -- 10:00 a.m. Pacific Time, ... San Francisco, ... will be available on,Stryker,s website at www.stryker.com via the For Investors ...
... WESTCHESTER, Ill., Jan. 7 BrainLAB, Inc., ... medical treatments,announces a new, customer-focused sales and ... growth and an expanding product,portfolio. , ... and support structures, customers will benefit,from a ...
Cached Medicine News:Health News:Senate and House Introduce Legislation to Repeal Therapy Caps 2Health News:Senate and House Introduce Legislation to Repeal Therapy Caps 3Health News:Gene abnormality found to predict childhood leukemia relapse 2Health News:Gene abnormality found to predict childhood leukemia relapse 3Health News:Gene abnormality found to predict childhood leukemia relapse 4Health News:Stryker To Present at Investor Conference 2Health News:BrainLAB, Inc. Announces New, Streamlined Surgery Business Division 2
... first wavefront aberrometer specifically designed to meet ... Practitioner. Utilizing a proprietary, non Hartmann-Shack technology ... accurately measures high order aberrations (3rd-6th order), ... to arrive at a fully optimized prescription ...
... Heidelberg Multi Color (HMC) ... a microprocessor-controlled precision assessment ... the red/green range (Rayleigh ... (Moreland equation) with integrated ...
... Alcons new Infiniti Vision System is ... surgical instrument. This single instrument now ... methods to remove a cataract. The ... and unique tri-modal energy delivery options ...
... MDoffice seamlessly integrates practice management ... and simplify office and clinical ... charting, billing, accounting and reporting ... facilities and specialties. MDoffice immediately ...
Medicine Products: