|By PR Newswire||
|November 10, 2012 09:01 AM EST||
BOSTON, Nov. 10, 2012 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. (Janssen) today announced that the use of one once-daily pill of the investigational protease inhibitor simeprevir (TMC435) administered with pegylated interferon and ribavirin led to higher rates of sustained viral response at 24 weeks (SVR24) compared to placebo in patients with Metavir scores of F3 and F4 who were treatment naive and treatment experienced with genotype 1 hepatitis C. Simeprevir was also generally well tolerated and the overall incidence of serious adverse events (AEs) was similar across all treatment arms. The data from the Phase 2b PILLAR and ASPIRE trials were presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
In treatment-naive patients with a Metavir score of F3 (PILLAR), the primary endpoint of SVR24 was achieved in 79 percent of patients in the simeprevir group compared to 72 percent in the control group (pegylated interferon and ribavirin alone). In treatment-experienced patients with a Metavir score of F3 (ASPIRE), SVR24 was achieved in 48 percent of patients in the simeprevir group compared to 8 percent in the control group. In treatment-experienced patients with a Metavir score of F4 (ASPIRE), SVR was achieved in 62 percent of patients in the simeprevir group compared to 0 percent in the control group. In both the PILLAR and ASPIRE trials, serious AEs occurred in 7.6 percent of patients receiving simeprevir plus pegylated interferon and ribavirin compared to 9.8 percent of patients receiving pegylated interferon and ribavirin alone.
"Hepatitis C patients with Metavir scores of F3 and F4 have advanced fibrosis of the liver and are harder to cure than those with limited fibrosis," said Fred Poordad, M.D., chief medical officer of Alamo Medical Research Center and investigator in the ASPIRE and PILLAR studies. "The results presented at AASLD suggest that simeprevir could represent an important new treatment option for people living with advanced hepatitis C if proven in advanced trials."
Simeprevir, an investigational NS3/4A protease inhibitor jointly developed by Janssen and Medivir, is currently in Phase 3 studies as a once-daily treatment taken in combination with pegylated interferon and ribavirin for the treatment of genotypes 1 and 4 chronic hepatitis C. It is also being studied in separate Phase 2 trials with other direct-acting antiviral agents as part of interferon-free regimens, with and without ribavirin. This includes a recently initiated Phase 2a trial of an interferon-free regimen with simeprevir and TMC647055, Janssen's non-nucleoside polymerase inhibitor (NNI) currently in development for hepatitis C.
"We are encouraged by these data, which show sustained viral response and tolerability in both treatment-naive and more challenging-to-cure patients," said Maria Beumont, M.D., Medical Leader for simeprevir, Janssen Research & Development. "We look forward to further evaluating the utility of simeprevir in combination with other agents for the treatment of hepatitis C."
About the PILLAR & ASPIRE Trials
In the two international, Phase 2b, randomized, double-blind, placebo-controlled studies, patients were either treatment naive (PILLAR) or treatment experienced (ASPIRE), and received pegylated interferon and ribavirin alone or in combination with once-daily simeprevir. In PILLAR, 309 treatment-naive hepatitis C patients received either 75 or 150 mg of once-daily simeprevir for 12 or 24 weeks plus pegylated interferon and ribavirin for 24 or 48 weeks depending on their response to treatment. In ASPIRE, 396 treatment-experienced patients received either 100 or 150 mg of once-daily simeprevir for 12, 24 or 48 weeks plus pegylated interferon and ribavirin for 48 weeks.
The post hoc analyses of PILLAR and ASPIRE presented at AASLD (abstracts 83 and 769) evaluated only patients receiving 150 mg of simeprevir and reporting a Metavir score of F3 (PILLAR), or F3 and F4 (ASPIRE). The Metavir score is used to quantify the degree of inflammation and fibrosis of the liver and patients are scored on a four-point scale. An F3 score means the patient has numerous septa (fibrous tissue bands that can decrease the flow of blood through the liver) without cirrhosis, while an F4 score means the patient has cirrhosis.
Simeprevir (TMC435) is a NS3/4A protease inhibitor jointly developed by Janssen and Medivir AB to treat chronic hepatitis C (HCV). Simeprevir is being studied in combination with pegylated interferon and ribavirin, and in combination with direct-acting antiviral agents in all-oral interferon-free regimens, with and without ribavirin.
Global Phase 3 studies of simeprevir include QUEST-1 and QUEST-2 in treatment-naive patients, PROMISE in patients who have relapsed after prior interferon-based treatment and ATTAIN in null-responder patients. In parallel to these trials, Phase 3 studies for simeprevir are ongoing in both treatment-naive and treatment-experienced HIV-HCV co-infected patients, HCV genotype 4 patients and in Japanese HCV genotype 1 patients.
Simeprevir is also being studied in Phase 2 interferon-free trials with and without ribavirin in combination with:
- Janssen's TMC647055 and ritonavir in treatment-naive, relapser or null-responder HCV genotype 1 patients;
- Gilead Sciences, Inc.'s sofosbuvir (GS-7977) in null-responder HCV genotype 1 patients; and
- Bristol-Myers Squibb's daclatasvir (BMS-790052) in treatment-naive or previous null-responder HCV genotype 1 patients.
In addition, Janssen recently announced that it has entered into a non-exclusive collaboration with Vertex Pharmaceuticals Incorporated to evaluate in a Phase 2 study the safety and efficacy of an all-oral regimen of simeprevir and Vertex's investigational nucleotide analogue polymerase inhibitor VX-135 for the treatment of HCV. As a first step, Janssen will conduct a drug-drug interaction (DDI) study with simeprevir and VX-135.
For additional information about simeprevir, please visit www.clinicaltrials.gov.
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease and liver transplants, is a rapidly evolving treatment area with a clear need for innovative treatments. Approximately 170 to 210 million people are infected with hepatitis C worldwide, with three to four million people newly infected each year.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in infectious diseases and vaccines, oncology, immunology, neuroscience, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Pharmaceuticals, Inc. is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents or other intellectual property rights; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen Pharmaceuticals, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
SOURCE Janssen Pharmaceuticals, Inc.
SYS-CON Events announced today that Logz.io has been named a "Bronze Sponsor" of SYS-CON's @DevOpsSummit Silicon Valley, which will take place November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Logz.io provides open-source software ELK turned into a log analytics platform that is simple, infinitely- scalable, highly available, and secure.
Oct. 5, 2015 07:30 AM EDT Reads: 764
DevOps is gaining traction in the federal government – and for good reasons. Heightened user expectations are pushing IT organizations to accelerate application development and support more innovation. At the same time, budgetary constraints require that agencies find ways to decrease the cost of developing, maintaining, and running applications. IT now faces a daunting task: do more and react faster than ever before – all with fewer resources.
Oct. 5, 2015 07:00 AM EDT Reads: 273
Today, we are in the middle of a paradigm shift as we move from managing applications on VMs and containers to embracing everything that the cloud and XaaS (Everything as a Service) has to offer. In his session at 17th Cloud Expo, Kevin Hoffman, Advisory Solutions Architect at Pivotal Cloud Foundry, will provide an overview of 12-factor apps and migrating enterprise apps to the cloud. Kevin Hoffman is an Advisory Solutions Architect for Pivotal Cloud Foundry, and has spent the past 20 years b...
Oct. 5, 2015 06:45 AM EDT Reads: 643
SYS-CON Events announced today that MobiDev, a software development company, will exhibit at the 17th International Cloud Expo®, which will take place November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software development company with representative offices in Atlanta (US), Sheffield (UK) and Würzburg (Germany); and development centers in Ukraine. Since 2009 it has grown from a small group of passionate engineers and business managers to a full-scale mobi...
Oct. 5, 2015 05:00 AM EDT Reads: 679
According to Forrester, public cloud platforms are evolving, blurring the lines between Software as a Service (SaaS), Infrastructure as a Service (IaaS), and Platform as a Service (PaaS) in order to satisfy the needs of enterprises and widen their appeal to developers. In The Forrester Wave™: Enterprise Public Cloud Platforms, Q4 2014, Forrester evaluates the 16 most significant Enterprise Public Cloud Platforms and details how each vendor fulfills the 19 evaluation criteria points.
Oct. 5, 2015 05:00 AM EDT Reads: 766
Data loss happens, even in the cloud. In fact, if your company has adopted a cloud application in the past three years, data loss has probably happened, whether you know it or not. In his session at 17th Cloud Expo, Bryan Forrester, Senior Vice President of Sales at eFolder, will present how common and costly cloud application data loss is and what measures you can take to protect your organization from data loss.
Oct. 5, 2015 04:00 AM EDT Reads: 455
The broad selection of hardware, the rapid evolution of operating systems and the time-to-market for mobile apps has been so rapid that new challenges for developers and engineers arise every day. Security, testing, hosting, and other metrics have to be considered through the process. In his session at Big Data Expo, Walter Maguire, Chief Field Technologist, HP Big Data Group, at Hewlett-Packard, will discuss the challenges faced by developers and a composite Big Data applications builder, foc...
Oct. 5, 2015 04:00 AM EDT Reads: 346
The cloud has reached mainstream IT. Those 18.7 million data centers out there (server closets to corporate data centers to colocation deployments) are moving to the cloud. In his session at 17th Cloud Expo, Achim Weiss, CEO & co-founder of ProfitBricks, will share how two companies – one in the U.S. and one in Germany – are achieving their goals with cloud infrastructure. More than a case study, he will share the details of how they prioritized their cloud computing infrastructure deployments ...
Oct. 5, 2015 03:00 AM EDT Reads: 652
DevOps delivers remarkable results. But does it help all of IT? Can traditional ‘mode 1’ IT benefit as much as innovative ‘mode 2’? How about the rest of your business? Or have you just shifted your bottleneck? And if so, what can you do about it? Improving dev and ops is necessary, but not sufficient. It often just shifts the burden sideways (e.g., to PMs, SQA, InfoSec, DBAs, NOC, etc.), upstream (to the PMO, Controller, Business Liaison, etc.), or downstream (to TechPubs, Service Desk, Traini...
Oct. 5, 2015 02:45 AM EDT Reads: 669
Decisions about budgets and resources are often made without IT even having a seat at the table. As technologist we understand the value of DevOps - but do your business counterparts? If they don't, your DevOps initiatives could lose funding before they start. In her session at DevOps Summit, Jeanne Morain, Strategist / Author at iSpeak Cloud, LLC, will provide insights on how to bridge the gap between business and technology leaders. Attendees will learn prescriptive guidance on balancing wor...
Oct. 5, 2015 02:00 AM EDT Reads: 541
Interested in leveraging automation technologies and a cloud architecture to make developers more productive? Learn how PaaS can benefit your organization to help you streamline your application development, allow you to use existing infrastructure and improve operational efficiencies. Begin charting your path to PaaS with OpenShift Enterprise.
Oct. 5, 2015 02:00 AM EDT Reads: 375
The modern software development landscape consists of best practices and tools that allow teams to deliver software in a near-continuous manner. By adopting a culture of automation, measurement and sharing, the time to ship code has been greatly reduced, allowing for shorter release cycles and quicker feedback from customers and users. Still, with all of these tools and methods, how can teams stay on top of what is taking place across their infrastructure and codebase? Hopping between services a...
Oct. 5, 2015 01:00 AM EDT Reads: 302
SYS-CON Events announced today that Machkey International Company will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Machkey provides advanced connectivity solutions for just about everyone. Businesses or individuals, Machkey is dedicated to provide high-quality and cost-effective products to meet all your needs.
Oct. 4, 2015 11:45 PM EDT Reads: 287
Clutch is now a Docker Authorized Consulting Partner, having completed Docker's certification course on the "Docker Accelerator for CI Engagements." More info about Clutch's success implementing Docker can be found here. Docker is an open platform for developers and system administrators to build, ship and run distributed applications. With Docker, IT organizations shrink application delivery from months to minutes, frictionlessly move workloads between data centers and the cloud and achieve 2...
Oct. 4, 2015 10:45 PM EDT Reads: 391
SYS-CON Events announced today that Interface Masters Technologies, provider of leading network visibility and monitoring solutions, will exhibit at the 17th International CloudExpo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Interface Masters Technologies is a leading provider of high speed networking solutions focused on Gigabit, 10 Gigabit, 40 Gigabit and 100 Gigabit Ethernet network access and connectivity products. For over 20 ye...
Oct. 4, 2015 10:15 PM EDT Reads: 641