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Newswise Medical News \| Tibotec Begins Enrollment for Phase III Study of Telaprevir Username: Password: forgotten login how to register ABOUT NEWSWISE Overview of Services Media Subscribers Source 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 size of varicella virus 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 News Keywords HEPATITIS C Contact Information Available for logged-in reporters only Description 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 failed prior therapy with peginterferon (Peg-IFN) plus ribavarin (RBV). 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. 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 failed prior therapy with peginterferon (Peg-IFN) plus ribavarin (RBV). 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 new virus mozilla the hemagglutinating virus of japan treatment of HCV, which may provide delete virus heat 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 treatment for stomach virus Optimize Outcomes) is a phase III, randomized, placebo-controlled double-blind study conducted over 72 weeks to examine two regimens of 750 mg telaprevir every eight hours all windows virus error (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 must belong to one of the following three groups: - Null responders (defined as patients who achieved <2 log reduction in HCV RNA at week 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 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 REALIZE study is sustained virologic response (SVR), defined as undetectable HCV RNA (<10 IU/mL) 24 weeks after the completion of 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 you are an idiot virus combination with standard doses of Peg-IFN and RBV, followed Virus Models by 36 weeks of treatment with Peg-IFN and RBV alone; 2. Delayed start arm, comprised of four weeks of Ypolio Virus Family And Shape treatment with Peg-IFN and RBV, followed by telaprevir dosed at 750 mg 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 standard doses of Peg-IFN and RBV dosed for 48 weeks. Patients free virus free 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 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 Free Virus Scan Windows committed to patient care, Tibotec uses innovative science and expertise to research, develop, manufacture and market drugs of unmet reviews of anti virus software need. Tibotec is dedicated to building a portfolio of novel antiviral therapies to address the significant unmet needs of patients with chronic hepatitis Online Virus Sacn C. In addition to its partnership with Vertex to develop and epstein barr virus and syndrome commercialize telaprevir, Tibotec is currently developing with partner Medivir a second potential treatment for HCV trend anti virus which is in early stage trials. Through the application of its deep understanding of virology and viral resistance, Tibotec has become an established leader in HIV/AIDS, having developed and made available two antiretroviral agents for the Disadvantages Of The Worm Virus treatment of HIV. Tibotec continues its commitment to developing novel therapies through a robust research and development program, which includes a third anti-HIV treatment as well as a potential treatment noro virus 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 free norton virus protection anti-infectives for diseases of high unmet Mobile Virus Threat 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 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 advances and patents attained by free virus heat removal competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic tobacco mosaic virus and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and storage protector virus 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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Newswise Medical News | Tibotec Begins Enrollment for Phase III Study of Telaprevir Username: Password: forgotten login how to register ABOUT NEWSWISE Overview of Services Media Subscribers Source 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 size of varicella virus 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 News Keywords HEPATITIS C Contact Information Available for logged-in reporters only Description 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 failed prior therapy with peginterferon (Peg-IFN) plus ribavarin (RBV). 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. 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 failed prior therapy with peginterferon (Peg-IFN) plus ribavarin (RBV). 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 new virus mozilla the hemagglutinating virus of japan treatment of HCV, which may provide delete virus heat 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 treatment for stomach virus Optimize Outcomes) is a phase III, randomized, placebo-controlled double-blind study conducted over 72 weeks to examine two regimens of 750 mg telaprevir every eight hours all windows virus error (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 must belong to one of the following three groups: - Null responders (defined as patients who achieved <2 log reduction in HCV RNA at week 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 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 REALIZE study is sustained virologic response (SVR), defined as undetectable HCV RNA (<10 IU/mL) 24 weeks after the completion of 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 you are an idiot virus combination with standard doses of Peg-IFN and RBV, followed Virus Models by 36 weeks of treatment with Peg-IFN and RBV alone; 2. Delayed start arm, comprised of four weeks of Ypolio Virus Family And Shape treatment with Peg-IFN and RBV, followed by telaprevir dosed at 750 mg 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 standard doses of Peg-IFN and RBV dosed for 48 weeks. Patients free virus free 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 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 Free Virus Scan Windows committed to patient care, Tibotec uses innovative science and expertise to research, develop, manufacture and market drugs of unmet reviews of anti virus software need. Tibotec is dedicated to building a portfolio of novel antiviral therapies to address the significant unmet needs of patients with chronic hepatitis Online Virus Sacn C. In addition to its partnership with Vertex to develop and epstein barr virus and syndrome commercialize telaprevir, Tibotec is currently developing with partner Medivir a second potential treatment for HCV trend anti virus which is in early stage trials. Through the application of its deep understanding of virology and viral resistance, Tibotec has become an established leader in HIV/AIDS, having developed and made available two antiretroviral agents for the Disadvantages Of The Worm Virus treatment of HIV. Tibotec continues its commitment to developing novel therapies through a robust research and development program, which includes a third anti-HIV treatment as well as a potential treatment noro virus 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 free norton virus protection anti-infectives for diseases of high unmet Mobile Virus Threat 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 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 advances and patents attained by free virus heat removal competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic tobacco mosaic virus and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and storage protector virus 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.

RNC: west nile virus in illinois Spreading the Virus - Yahoo! News Try the new Yahoo! solaris virus scanning News » Primary Navigation Home U.S. Business World Entertainment Sports Tech Politics Elections Science Health Most Popular Secondary Navigation Politics Video Elections White House Congress U.S. Government World Supreme Court Press Releases Search: All News Yahoo! News Only News Photos Video/Audio Advanced RNC: Spreading the Virus Tue Oct 14, 12:36 PM ET To: POLITICAL EDITORS Contact: Republican National Committee, +1-202-863-8614 WASHINGTON, Oct. 14 /PRNewswire-USNewswire/ -- The following OP-ED is an excerpt from an article by Stanley Kurtz Detect Boot Sector Virus from The New York Post, and is being released today by the Republican National Committee: (LOGO: http://www.newscom.com/cgi-bin/prnh/20080519/RNCLOGO ) To discover the roots of today's economic crisis, consider a tale from 1995. That March, House Speaker Newt Gingrich was scheduled to address a meeting of county commissioners at the Washington Hilton. But, first, some 500 protesters from the Association of Community Organizations for Reform Now (ACORN) poured into the ballroom first virus from both the kitchen and the main entrance. ... The demonstrators' target, Gingrich, hadn't yet arrived -- and his speech was cancelled. When the cancellation flu virus and neurological disorders was announced, ACORN's foot soldiers cheered. ... Yet ACORN had only just begun. Two days later, 50 to how to write a virus 100 of the same protesters hit their main target -- vario anti virus a House Banking subcommittee considering changes to the ntfs virus Community Reinvestment Act, a law that allows groups like ACORN to force banks into making high-risk loans to low-credit customers. The CRA's ostensible purpose is to prevent banks from discriminating against minorities. But Rep. Marge Roukema (R-NJ), who chaired the subcommittee, was worried that charges of discrimination had become an excuse for lowering credit standards. She warned that new, Democrat-proposed CRA regulations could amount to an illegal quota system. ... When the role of ACORN and congressional Democrats in the mortgage crisis is pointed out, Democrats reply that banks subject to the CRA represent only about a quarter of the loans that led to our current troubles. In fact, the problem goes way beyond the CRA. As ACORN ran its campaigns against local banks, it quickly hit a roadblock. Banks would tell ACORN they could afford to reduce their credit standards by only a little -- since Fannie Mae and Freddie Mac, the federal mortgage giants, refused to buy up those risky loans for sale on the "secondary market." ... So ACORN's Democratic friends in Congress moved to force Fannie Mae and Freddie Mac to dispense with normal credit standards. Throughout the early '90s, they imposed ever-increasing subprime-lending quotas on Fannie and Freddie. But then the Republicans won control of Congress -- and Rep. Roukema scheduled her hearing. ACORN went into action to protect its golden goose. ... This little slice of political life from 1995 had a variety of ripple effects. Above all, ACORN's intimidation tactics, and its alliance with Democrats in Congress, triumphed. Despite their 1994 takeover of Congress, Republicans' attempts to pare back the CRA were stymied. ... How does Barack Obama fit into all of this? Obama has been a key ally of Chicago ACORN going back to his days as a community organizer. Later, as a young lawyer, he offered leadership training to the activists who were forcing Chicago banks into high-risk lafee virus subprime loans. And when he made it on to the boards of Chicago's Woods Fund and the Chicago Annenberg Challenge, he channeled money ACORN's way. Obama was perfectly aware of ACORN's intimidation tactics -- indeed, he oversaw a Woods Fund report that boasted of managing to fund the radical group despite its shocking behavior. And as a lawmaker, in Illinois and in Washington, he has continued to back ACORN's legislative agenda. ACORN's high-pressure tactics live on. And congressional Democrats are still covering for ACORN, funneling it money and doing its legislative bidding. ACORN also continues its shady ways, using a vast network of technically separate but

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in fact quite interconnected organizations to evade federal laws on the politicized use of government money. Perhaps most disturbing trend micro free virus scan of all, the Obama campaign appears better business bureau virus to have little more regard for freedom of speech than Reps. Kennedy or Waters did when they backed up ACORN's thugs in 1995. The campaign actually practices ACORN-style tactics, sending out "action wires" that call on supporters to block Obama critics from radio appearances (a tactic once applied to me) and demanding legal actions against unfriendly political advertisers. As a presidential candidate, Obama promises a massive national-service program closely allied with the nonprofit sector. He wants to remove "barriers for smaller nonprofits to participate in government programs." In other words, he plans a massive effort to funnel America's youth into volunteer work alongside the likes of ACORN. So Obama's favorite community organizers may soon be training your child. ACORN's alliance with the Democratic Party is at the root of the current financial meltdown. And Barack Obama has stayed true to ACORN's ways. ... To View The Entire Article, Please Visit: http://www.nypost.com/seven/10132008/postopinion/opedcolumnists/spreading_the_virus_133375.htm A Product Of The RNC Research Department Paid for by the Republican National Committee. Not authorized by any candidate or candidate's committee. SOURCE Republican National Committee -0- Email Story IM Story Printable View Politics News McCain seeks to recharge candidacy at final debate AP RNC pulls ads from Wisconsin, Maine to smv virus focus on red states AP Republicans pull ads in key Senate and House races AP Murtha: Western Pa. 'racist' but fake virus Obama should win AP Palin not going negative 'at all' Politico Most Viewed - Politics Pre-debate talking points: Raising expectations Politico Murtha: Western Pa. 'racist' but Obama should win AP RNC out of Wisconsin, Maine; focuses on red states AP About 200K Ohio voters have records discrepancies AP McCain seeks to recharge candidacy at final debate AP Politics Video Is free virus control This McCain's Last Chance? ABC News - Wed Oct 15, 9:29 AM ET Irregular Heartbeat Troubles Cheney ABC News - Wed Oct 15, 2:01 PM ET 106-Year-Old Nun Votes From Rome ABC News - Wed Oct 15, 10:00 AM ET Politics in No Time Yahoo! TV - Wed Oct 15, 7:18 AM ET Politics Video Is This McCain's Last Chance? ABC News Irregular Heartbeat Troubles Cheney ABC News » All news video News Search Related Searches: ACORN RNC Stanley Kurtz financial meltdown Elsewhere on the Web McClatchy Newspapers: Acorn may be victim, not perpetrator, in windows cannot open exe virus registration cases Politico: McCain, advisers divided over Wright ABC News: Debate mcafee free virus scan D-Day: McCain Needs Knockout Good Morning Yahoo! 1 man, 1 day, 100 skydives Play Speed-jumping feat is all for a good cause See today's talked-about videos Yahoo! Games New Games Take a break and play some hot, new games now! NEWS ALERTS Get an alert when there are new stories about: SOURCE Republican National Committee ACORN RNC Stanley Kurtz financial meltdown » More alerts Yahoo! - My Yahoo! - Mail Search: All News Yahoo! News Only News Photos Video/Audio Advanced Primary Navigation Home U.S Business World Entertainment Sports Tech Politics Science Health Travel Most Popular Odd News Opinion

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