Hepatitis C Update Phase III Trial of TMC435 Now Recruiting/Link

[Guest guest]

Hepatitis C Update Phase III Trial of TMC435 Now Recruiting/Link

Click Here For Trial Information; TMC435HPC3007 - Phase III Trial of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous TherapyThis study is currently recruiting participants. LocationsUnited States, California Recruiting Bakersfield, California, United States Not yet recruiting Los Angeles, California, United States United States, Colorado Recruiting Aurora, Colorado, United States United States, Florida Recruiting ville, Florida, United States Recruiting Orlando, Florida, United States United States, Georgia Recruiting Atlanta, Georgia, United States United States, Kentucky

Recruiting Florence, Kentucky, United States United States, Minnesota Recruiting Saint , Minnesota, United States United States, Mississippi Recruiting , Mississippi, United States United States, Tennessee Recruiting Germantown, Tennessee, United States United States, Texas Recruiting Houston, Texas, United States Recruiting San , Texas, United States Australia Not yet recruiting Adelaide, Australia Not yet recruiting Kingswood, Australia Not yet recruiting Melbourne, Australia Not yet recruiting Sydney, Australia Not yet recruiting Woolloongabba N/A, Australia Austria Recruiting Wien, Austria Not yet recruiting Wien, Austria Belgium Recruiting Antwerpen,

Belgium Recruiting Brugge, Belgium Not yet recruiting Brussel, Belgium Recruiting Brussels, Belgium Not yet recruiting Gent, Belgium Not yet recruiting Leuven, Belgium Canada, British Columbia Recruiting Vancouver, British Columbia, Canada Canada, Ontario Not yet recruiting Ottawa, Ontario, Canada Not yet recruiting Toronto, Ontario, Canada Canada, Quebec Not yet recruiting Montreal, Quebec, Canada France Not yet recruiting Creteil N/A, France Recruiting Grenoble, France Not yet recruiting Lyon, France Recruiting Nice N/A, France Not yet recruiting Paris, France Not yet recruiting Paris Cedex 12, France Not yet recruiting Rennes Cedex, France Not yet recruiting

Vandoeuvre Les , France Germany Recruiting Berlin, Germany Recruiting Düsseldorf, Germany Not yet recruiting furt, Germany Recruiting Freiburg, Germany Not yet recruiting Halle (Saale), Germany Recruiting Hamburg, Germany Recruiting Kiel, Germany Recruiting Leipzig, Germany Recruiting Munchen, Germany Recruiting Würzburg, Germany Israel Not yet recruiting Haifa, Israel Not yet recruiting Hedera, Israel Not yet recruiting Nazareth, Israel Not yet recruiting Petah Tikva, Israel Not yet recruiting Zefat, Israel New Zealand Not yet recruiting Auckland, New Zealand Not yet recruiting Christchurch, New Zealand Not yet recruiting

Hamilton, New Zealand Poland Recruiting Bialystok, Poland Recruiting Bydgoszcz, Poland Recruiting Czeladz, Poland Recruiting Kielce, Poland Recruiting Krakow, Poland Recruiting Warszawa, Poland Puerto Rico Not yet recruiting Ponce Pr, Puerto Rico Recruiting San , Puerto Rico Russian Federation Not yet recruiting Ekaterinbourg, Russian Federation Not yet recruiting Moscow, Russian Federation Not yet recruiting Saint-sburg, Russian Federation Not yet recruiting Samara, Russian Federation Not yet recruiting Smolensk, Russian Federation Not yet recruiting St sburg, Russian Federation Not yet recruiting Stavropol, Russian Federation Spain Recruiting

Barcelona, Spain Recruiting Madrid, Spain Recruiting Sevilla N/A, Spain Recruiting Valencia, Spain United Kingdom Recruiting Birmingham, United Kingdom Not yet recruiting Derby, United Kingdom Recruiting Glasgow, United Kingdom Not yet recruiting London, United Kingdom Recruiting London, United Kingdom Recruiting Plymouth, United Kingdom Sponsors and CollaboratorsTibotec Pharmaceuticals, IrelandInvestigatorsStudy Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited Press Release; Medivir - The Phase 3 Program for TMC435 in Treatment-Naive Patients and Patients who Have Relapsed After Prior Interferon-Based Treatment HUDDINGE, Sweden, February 18, 2011/PRNewswire-FirstCall/ --Medivir AB (OMX:

MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, notes that its development partner, Tibotec Pharmaceuticals, announced today that the global phase 3 studies with TMC435 in treatment-naive patients and patients who have relapsed after prior SOC treatment have started.Phase 3 Program in brief:- TMC435-C208 or QUEST-1 includes approximately 375 treatment-naivepatients- TMC435-C216 or QUEST-2 includes approximately 375 treatment-naivepatients- TMC435-C3007 or PROMISE includes approximately 375 who haverelapsed after prior interferon-based treatmentMedivir's CEO, Ron Long,"This is a momentous and important step for both the project and for Medivir as a company. It is impressive to see Tibotec's diligence and enterprise in developing TMC435 in a time-effective and thorough fashion."The phase 3 milestone of Euro 5 million flagged

in February 2010 will now be recognized as income in the first quarter 2011.Tibotec released today the following statement:Cork, Ireland, February 17, 2011 - Tibotec Pharmaceuticals announced today that two global, registrational phase 3 trials are recruiting patients to examine TMC435, its investigational hepatitis C protease inhibitor, in treatment-naive adults with chronic genotype 1 hepatitis C virus (HCV). A third global phase 3 trial is being conducted in genotype 1 HCV patients who have experienced a viral relapse after prior interferon-based treatment.Approximately 3.2 million people in the U.S. live with chronic hepatitis C disease and more than 170 million people have the disease globally.,[ii] The response-guided trials will compare the efficacy, safety and tolerability of TMC435 given as a single 150 mg oral tablet once daily for 12 weeks versus placebo; each patient also will be treated with a background regimen

of peginterferon and ribavirin for 24 or 48 weeks."TMC435 is an important component of our growing HCV pipeline said Woodfall M.D., Vice President of Global Clinical Development at Tibotec." "The initiation of the TMC435 phase 3 clinical trial program reinforces our commitment to develop innovative new treatment options that may decrease the duration of treatment for patients with chronic hepatitis C infection."Three global studiesThe first global, phase 3, double-blind, randomized study, known as TMC435-C208 or QUEST-1 (QD dosing of TMC435 of previoUsly untreated GEnotype 1 patienTs-1), will evaluate a single TMC435 once-daily oral tablet (150 mg) versus placebo in treatment-naive HCV patients. Both groups will also receive peginterferon alfa-2a (Pegasys®) and ribavirin (Copegus®) as part of their treatment.The second global, phase 3, double-blind, randomized study, known as TMC435-C216 or QUEST-2 (QD dosing of

TMC435 of previoUsly untreated GEnotype 1 patienTs-2), also will evaluate a single TMC435 once-daily oral tablet (150 mg) versus placebo in treatment-naive HCV patients. However, patients in this trial will either receive peginterferon alfa-2a (Pegasys®) and ribavirin (Copegus®) or peginterferon alfa-2b (PegIntron®) and ribavirin (Rebetol®) as part of their treatment.A third global, phase 3, double-blind randomized study, known as TMC435-C3007 or PROMISE (PROtease inhibitor TMC435 In PatientS who have previously rElapsed on IFN/RBV), will evaluate a single TMC435 once-daily oral tablet (150 mg) verses placebo in HCV patients who experienced viral relapse after previous interferon-based therapy. Both groups will receive peginterferon alfa-2a (Pegasys®) and ribavirin (Copegus®). The complete treatment duration for all three trials will be 24 or 48 weeks, depending on patient response.In parallel to these trials phase 3 studies

for TMC435 have also recently been launched in Japan. ...Centers and inclusion criteria'sThe studies will be conducted at more than 160 sites in 24 countries, including the U.S. and countries throughout Europe, and together seek to enroll approximately 1,125 HCV genotype 1 infected patients who are treatment-naive or have experienced a relapse after previous interferon-based HCV therapy. To be eligible, patients must have chronic hepatitis C infection, and must have had a liver biopsy within three years of the screening visit. For those patients who have not had a liver biopsy in the three years prior to the study, one will be performed before the baseline visit. In addition, eligible patients need to have completed a recent ultrasound with no findings suspicious of hepatocellular carcinoma (HCC). Patients with signs of hepatic decompensation, liver disease of any non-HCV etiology, co-infection with hepatitis B or HIV-1 and 2 or a

history of malignancy within 5 years of the screening visits are ineligible for the study.Patients in QUEST-1 and QUEST-2 trials must not have received any prior treatment for hepatitis C, and patients in the PROMISE trial must have previously received at least 24 weeks of (peg)interferon-based therapy, along with documented negative HCV RNA at last on-treatment measurement, and have relapsed (detectable HCV RNA) within one year of last taking medication.The primary endpoint of the studies is to assess whether TMC435 is superior to placebo in achieving sustained virologic reponse (SVR), defined as HCV RNA less then 25 IU/ml undetectable, 24 weeks after the planned end of treatment (SVR 24), with the final analysis being performed after the last patient reaches week 72 of the study. Secondary endpoints include superiority of TMC435 versus placebo at 12 weeks (SVR 12), after planned end of treatment and at week 72 of the study.

Evaluations of viral breakthroughs, relapse rates in treatment groups, safety and tolerability also will be assessed. About TMC435 in other clinical studiesTMC435 is a once-daily (q.d.) protease inhibitor drug jointly developed by Medivir and Tibotec Pharmaceuticals, to treat chronic hepatitis C virus infections. In parallel to the recent start of the global phase 3-studies, TMC435 is currently in a follow up phase in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1 patients that failed previous IFN-based treatment. More safety and efficacy data from the phase 2b trials will be presented at scientific meetings later in 2011.For additional information for these studies, please see http://www.clinicaltrials.gov/ About Hepatitis CHepatitis C is a blood-borne infectious disease

of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.For additional information, please contact Medivir (http://www.medivir.com/ / ) Rein Piir, CFO & VP Investor Relations Mobile: +46-708-537-292 M:Communications Medivir@... Europe: -Jane Elliott/ Amber Bielecka /Nick Francis +44(0)20-7920-2330 USA: Roland Tomforde +1-212-897-5497Source: Medivir

http://Hepatitis Cnewdrugs.blogspot.com/2011/04/hepatitis-c-update-phase-iii-trial-of.html