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:9/30/2014)... , Sept. 30, 2014  Decision Resources Group ... in Brazil , Russia ... China (BRIC) will see robust expansion ... increasingly favored over surgical procedures. Although revenues will be ... reimbursement challenges, prolonged device approval times and demand for ...
(Date:9/30/2014)... According to the ... Product [Enzymes (Glycosyltransferase, Neuraminidase, Glycosidase), Instruments (HPLC, ... (Immunology, Oncology) & by End User - ... provides a detailed overview of the major ... and strategies impacting the global glycomics enzymes, ...
(Date:9/30/2014)... Ky. , Sept. 30, 2014 A ... tomography (OCT), offered a new look at the composition ... alter how physicians understand and treat the disease, a ... conducted at Baptist Health Lexington between September 2010 and ... of the Journal of the American College of ...
Breaking Medicine Technology:Brazilian, Russian, Indian and Chinese Markets for Peripheral Vascular Devices Will See Strong Expansion Through 2023 2Brazilian, Russian, Indian and Chinese Markets for Peripheral Vascular Devices Will See Strong Expansion Through 2023 3Glycobiology / Glycomics Market Worth $928.11 Million by 2019 2Glycobiology / Glycomics Market Worth $928.11 Million by 2019 3Glycobiology / Glycomics Market Worth $928.11 Million by 2019 4New Imaging Tool May Allow Tailoring of Stroke Prevention to Each Patient 2
... UCB) and U.S. based partner Immunomedics Inc. (Nasdaq: ... IIb study, EMBLEM™, showed that certain doses of epratuzumab ... in disease activity in adult patients with moderate to ... designed to evaluate the efficacy and safety of epratuzumab ...
... innovator of Packaging Execution Systems (PES) for the pharmaceutical ... engineering, automation and manufacturing optimization services company, today announced ... Service Provider (SSP). VCG will now sell, install and ... United States. The SSP program is ...
Cached Medicine Technology:Epratuzumab Phase IIb Data Presented at ACR Show Pipeline Drug had Positive Effect in Patients Suffering From Moderate to Severe Systemic Lupus Erythematosus 2Epratuzumab Phase IIb Data Presented at ACR Show Pipeline Drug had Positive Effect in Patients Suffering From Moderate to Severe Systemic Lupus Erythematosus 3Epratuzumab Phase IIb Data Presented at ACR Show Pipeline Drug had Positive Effect in Patients Suffering From Moderate to Severe Systemic Lupus Erythematosus 4Epratuzumab Phase IIb Data Presented at ACR Show Pipeline Drug had Positive Effect in Patients Suffering From Moderate to Severe Systemic Lupus Erythematosus 5Epratuzumab Phase IIb Data Presented at ACR Show Pipeline Drug had Positive Effect in Patients Suffering From Moderate to Severe Systemic Lupus Erythematosus 6Epratuzumab Phase IIb Data Presented at ACR Show Pipeline Drug had Positive Effect in Patients Suffering From Moderate to Severe Systemic Lupus Erythematosus 7Systech International and Vantage Consulting Group Partner to Address Emerging U.S. Pharmaceutical Regulatory Requirements 2Systech International and Vantage Consulting Group Partner to Address Emerging U.S. Pharmaceutical Regulatory Requirements 3
(Date:9/30/2014)... September 30, 2014 Dynamic health ... hampered growth in the Bread Production industry over ... consumers to moderate their consumption of a variety ... premium varieties shrunk the market for white loaf ... proactively responded by introducing more nutritious products to ...
(Date:9/30/2014)... Federally Qualified Health Centers (FQHCs) granted new patient ... higher rates than other primary care practices (non-FQHCs), ... to results of a new 10-state University of ... Care . , Using data from a previous ... the investigators found that FQHCs community health ...
(Date:9/30/2014)... of allergy-related sudden deaths in the U.S., according to ... conducted by researchers at Montefiore Medical Center ... Yeshiva University . The study, published online today in ... also found that the risk of fatal drug-induced allergic ... and that such deaths increased significantly in the U.S. ...
(Date:9/30/2014)... NV (PRWEB) September 30, 2014 ... Blue Star Nutraceuticals designed to help maximize lean, strong ... optimizes the body’s absorption of glucose has caught the ... , “The main purpose behind Glycodrive is to help ... lean muscle,” reports Michaels. “Carbs are essential in the ...
(Date:9/30/2014)... (PRWEB) September 30, 2014 Fat Burning ... specialist and best-selling author Mike Geary that is helping people ... their body into a fat-burning machine in less than 24 ... investigative review. , “In our culture that is becoming ... hard to decipher what is really fact and fiction when ...
Breaking Medicine News(10 mins):Health News:Bread Production in the US Industry Market Research Report from IBISWorld Has Been Updated 2Health News:Bread Production in the US Industry Market Research Report from IBISWorld Has Been Updated 3Health News:Medicaid and Uninsured patients obtain new patient appointments most easily at FQHCs 2Health News:Comprehensive Study of allergic deaths in US finds medications are main culprit 2Health News:Glycodrive Review Exposes Blue Star Nutraceutical’s Supplement for Leaner, Stronger Muscles 2Health News:Fat Burning Kitchen: Review Exposes Mike Geary’s 24-Hour Diet Transformation for Helping the Body Burn Fat Through a Natural Diet 2Health News:Fat Burning Kitchen: Review Exposes Mike Geary’s 24-Hour Diet Transformation for Helping the Body Burn Fat Through a Natural Diet 3
... Hammer toes, curly toes, crossover toes and bunions are not only ... a new report warns. According to a review published in ... of Orthopaedic Surgeons , deformities of the lesser toes, which includes ... as early as possible by an orthopaedic surgeon to avoid other ...
... of men undergoing surgery for prostate cancer expect better recovery ... attain one year after the operation, a University of Michigan ... to surgery, a small proportion of men had expected to ... the surgery than they had before it the exact ...
... a recent issue of Cancer Research, Daniel J. Powell, ... Laboratory Medicine and Obstetrics and Gynecology at the Perelman ... for the first time that engineered human T cells ... Ovarian cancer is the most lethal reproductive cancer ...
... In an innovative collaboration designed to speed the process ... California, San Diego Health Sciences announced today that UC ... life science research institutions across the country as part ... collaborative partnerships formed through the Centers for Therapeutic Innovation ...
... -- Smokers who light up right after they wake up in ... neck cancers than those who wait longer before having their first ... was released online Aug. 8 in advance of publication in an ... smokers have higher levels of nicotine and possibly other tobacco toxins ...
... Alexandria, VA Dale Browne, MD, of Winston Salem, ... and Neck Surgery (AAO-HNS) Distinguished Service Award at the ... OTO EXPO, in San Francisco, CA, September 11-14, 2011. ... professionals in recognition of extensive meritorious service through the ...
Cached Medicine News:Health News:Toe Deformities Should Be Treated Early: Experts 2Health News:Men have overly optimistic expectations about recovery from prostate cancer surgery, U-M study finds 2Health News:Penn study finds more effective approach against 'Achilles' heel' of ovarian cancer 2Health News:UCSD Health Sciences partners with Pfizer to speed drug delivery 2Health News:UCSD Health Sciences partners with Pfizer to speed drug delivery 3Health News: Early Morning Smoking Riskier For Cancer 2
... Comfort Pick one of our pipettors up ... trigger and ejector positionsright where they should beeven ... ergonomically designed to help avoid repetitive stress injuries ... In The Palm Of Your Hand Start ...
... Ergonomic Design for Unparalleled Comfort Pick one ... the balance. Notice the trigger and ejector positionsright ... because our pipettors are ergonomically designed to help ... of pipetting. Productivity In The Palm Of ...
... Ergonomic Design for Unparalleled Comfort ... it. Notice the balance. Notice the trigger and ... left-handed. Thats because our pipettors are ergonomically designed ... long hours of pipetting. Productivity In The ...
... The total ergonomic solution and best value ... feather touch action and ultra lightweight design ... tip ejection with long, lever tip ejector ... , Accepts universal tips or for greater ...
Medicine Products: