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Newswise Medical News | Tibotec Begins Enrollment

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for Phase III Study of Telaprevir Username: Password: forgotten login how to register ABOUT NEWSWISE Overview of Services   Media Subscribers   Source vpn firewall virus security Institutions   What's New   Contact Us   LIBRARIES Latest News   SciNews   MedNews   LifeNews   BizNews   Video/Audio   RSS Feeds   Search   CHANNELS Breaking News   Features   RESOURCES Expert Finder Tools   Contact Directory   Meetings Calendars   Awards for Journalists   Grants for Journalists   SUPPORT Newswise Community   How to Register   © Newswise. All Rights Reserved. Source: Zeno Group, DC     Released: Wed 15-Oct-2008, 08:00 ET  Embargo expired: Wed 15-Oct-2008, 08:00 ET  Printer-friendly Version  Tibotec Begins Enrollment for Phase III Study of Telaprevir Libraries Medical virus heat removal help News   Keywords HEPATITIS C Contact Information Available for logged-in reporters only Description Tibotec BVBA announced today that freee virus protection it has begun enrolling patients in its phase III clinical trial evaluating telaprevir, an investigational hepatitis C virus protease inhibitor, in patients who failed prior therapy with peginterferon (Peg-IFN) plus ribavarin (RBV). The trial, known as REALIZE, will compare the efficacy, safety and spyhunter virus downloads tolerability of telaprevir combined with Peg-IFN plus RBV versus Peg-IFN and RBV alone, the current standard of care. Investigators at U.S. trial centers have begun screening patients computer virus protection reviews for participation in the study, with global centers expected to begin screening in the coming weeks. Newswise — Tibotec BVBA announced today that it has begun enrolling patients in its phase III clinical trial evaluating telaprevir, an investigational hepatitis C virus protease inhibitor, in patients who free download of avg virus protection failed prior therapy with peginterferon (Peg-IFN) plus ribavarin (RBV).

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The trial, known as REALIZE, will compare the efficacy, safety and tolerability of telaprevir combined with Peg-IFN plus RBV versus Peg-IFN and RBV alone, the current standard of care. Investigators at U.S. trial centers have begun screening patients for participation in the study, with global centers expected to begin screening in the coming weeks. Telaprevir is being co-developed by Vertex Pharmaceuticals Incorporated and Tibotec. Tibotec, the sponsor of the REALIZE trial, is managing the trial worldwide. “We are excited about the ongoing development of telaprevir, potentially the first direct antiviral for the treatment of HCV, which may provide a new option for patients who have failed the current standard of care,” said Roger Pomerantz, MD, President, Tibotec Research and Development. “We are committed to examining the safety and efficacy of telaprevir through phase III trials and look forward to working with health authorities with the goal of making this therapy available to HCV infected patients.” The REALIZE trial (Re-treatment of Patients with Telaprevir-based Regimen to Optimize Outcomes) is a phase III, randomized, placebo-controlled double-blind study conducted over 72 weeks to examine two regimens of 750 mg trend virus encyclopedia telaprevir every eight hours (with and without a delayed start) combined with Peg-IFN and RBV versus Peg-IFN and RBV alone. To be eligible for the study, patients adbaze and virus must belong to one of the following three groups: - Null responders (defined as patients who achieved <2 log reduction in HCV RNA at week virus from msn link 12 of prior therapy); - Partial responders (defined as patients who achieved at least a 2 log reduction at week 12, but never achieved undetectable HCV RNA during prior therapy); and - Relapsers (defined as patients who had undetectable HCV RNA at the completion of at least 42 weeks of prior treatment, but relapsed during follow-up). The trial will enroll approximately 650 HCV patients at more than 30 centers in the U.S., 50 centers in Europe and 20 centers in the rest of the world. The study will include 300 null- and partial-responder patients and 350 Ca Anti Virus Suite patients with viral relapse. REALIZE is the first phase III study to evaluate a direct antiviral (or STAT-C) treatment for HCV in null responder patients. The primary endpoint of the mac anti virus REALIZE study is sustained marvo virus virologic response (SVR), defined as undetectable HCV RNA virus heur gwmdmpi (<10 IU/mL) 24 weeks after Stubborn Computer Virus Free the completion of spyware virus protection treatment. Patients enrolled in this study will be randomized to three treatment arms: 1. Telaprevir dosed at 750 mg every eight hours (q8h) for 12 weeks in combination with standard doses of Peg-IFN and RBV, followed by 36 weeks of treatment with Peg-IFN and RBV alone; 2. Delayed start arm, comprised of four weeks of treatment with Peg-IFN and RBV, followed by telaprevir dosed at 750 mg messenger virus remove taquiza q8h for 12 weeks in combination with standard doses of Peg-IFN and RBV, followed by another 32 weeks of Peg-IFN and RBV alone; or 3. A control arm with pipistrel aircraft virus standard doses of Peg-IFN and RBV dosed for 48 weeks. Patients in all treatment arms will be followed for 24 weeks after completion of treatment to assess SVR. For additional information on inclusion and exclusion criteria for this study, please see www.clinicaltrials.gov. The REALIZE phase III study in treatment failure patients is part of a comprehensive clinical development program for telaprevir. Vertex is managing israli acute paralysis virus the ADVANCE phase III trial in treatment-naïve patients. Tibotec has the right to develop and commercialize telaprevir in Europe, South America, the Middle East, Africa, India, Australia and New Zealand. Vertex will commercialize telaprevir in the U.S., Canada and Mexico. As a global virology leader committed to patient care, Tibotec uses innovative science and expertise to research, develop, manufacture and vomit virus market drugs of unmet need. Tibotec is dedicated to building a portfolio of novel antiviral therapies to address the significant unmet needs of patients with chronic precipitation virus picture hepatitis C. In addition to its partnership with Vertex to develop and commercialize telaprevir, Tibotec is currently developing with partner Medivir a second potential treatment for HCV which is in early stage trials. Through the application of storage protetor virus its deep understanding of virology and viral resistance, Tibotec has become an established leader in HIV/AIDS, having developed Epson Barr Virus and made available two antiretroviral agents for the treatment of HIV. Tibotec continues its commitment to developing novel therapies through a robust research and trax virus generator development program, which includes a third anti-HIV treatment as well as a potential treatment for tuberculosis. About Tibotec BVBA Tibotec BVBA is a global pharmaceutical and research development company. The Company’s main research and development facilities are in Mechelen, Belgium with offices in Yardley, Pa. and Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS and hepatitis C drugs, and anti-infectives for diseases of high unmet medical need. Forward Looking Statement This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If virus software manufactures underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Tibotec BVBA’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological Msn Free Emotions Fake Virus advances Free Virus And Spyware Removers and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and crush card virus yugioh gold trends toward health care cost containment. 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 December 31, 2006. 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 Tibotec BVBA or Johnson & Johnson. Tibotec BVBA does not undertake to update any forward-looking statements as a result of new information or future events or developments. Tibotec is a member of the Johnson & Johnson family of companies. © 2008 Newswise.  All Rights Reserved.  
 



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In Mississippi, Now A New Mosquito-Borne Virus Shows Up Contributor: Jim Turpin Email: Web-Team@MyEyewitnessNews.com Last Update: 9:32 am Related Video |  Print Story | Email Story JACKSON, Miss. (AP) -- Mississippi health officials are reporting three new human cases of the West Nile virus, bringing the total number of state cases this year to 99 with three deaths. The state Department of Health says the new cases cyrus the virus in con air are in Hinds, Jackson and Leflore counties. Officials also reported case of another mosquito-borne virus, deleting a trojan virus Jamestown Canyon virus, in Lamar County. The agency reports both confirmed and probable cases and conducts statewide mosquito testing. Symptoms of West Nile virus infection are automatic updates virus often mild and may include fever, headache, nausea, vomiting, a Replication Of Hiv Virus rash, muscle weakness or swollen lymph nodes. In a small number of cases, infection can result skull monkey virus in encephalitis or virus you got mail meningitis, macintosh virus scan software which can lead to paralysis, coma and possibly death. Email Story To Email: Your Name: Your Email: Message: Send a copy to my email You can send a story online scan virus removal to multiple email addresses by separating the email addresses with super virus low grade fever a semicolon (;) This station will not store your email address or your recipient's email address or use them in any way. Add a Comment Add Video Comment (1) Comments Most Popular Agents Make herpes virus information Major Marijuana Bust

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