Navigation Links
Tibotec presents interim findings for TMC435, an investigational genotype 1 hepatitis C treatment
Date:11/3/2008

SAN FRANCISCO (November 3, 2008) New clinical data show antiviral activity of TMC435, an investigational protease inhibitor (PI) being developed by Tibotec BVBA for the treatment of chronic hepatitis C virus (HCV) infection. Tibotec will present findings from three TMC435 studies, including a late-breaker poster on the proof-of-principle phase IIa trial, OPERA-1 (TMC435-C201), at the American Association for the Study of Liver Disease's (AASLD) Liver Meeting 2008 in San Francisco.

The current standard of care treatment for HCV infection, pegylated interferon (Peg-IFN) combined with ribavirin (RBV), is effective in 30 to 50 percent of patients infected with chronic genotype 1 HCV infection, the most common type in the United States. The development of new therapies and strategies for treating HCV, particularly the introduction of direct antivirals, may offer patients a new option with shorter treatment duration.

TMC435 Phase IIa Study Results

In interim findings from the first 28 days of treatment for the first cohort of fifty (50) treatment nave HCV+, genotype 1, patients (once daily dose of 25 mg or 75 mg TMC435 versus placebo), both doses showed dose-dependent antiviral activity. TMC435 was administered in combination with PegIFNα-2a/RBV (triple therapy) for 28 days or as monotherapy for seven days and, thereafter, in combination with PegIFNα-2a/RBV (triple therapy) for three weeks. There were neither serious adverse events, nor grade 3 or 4 adverse events, related to TMC435 or any safety-related treatment discontinuations during this 28 day treatment period.

The most common adverse events associated with TMC435 were nausea, diarrhea, and headache. There were no clinically relevant changes in laboratory parameters, ECGs, or vital signs. Steady-state plasma trough levels of TMC435 25 mg and 75 mg represented ~10 and >30-fold excess above the HCV replicon EC50 value, respectively.

Mean reductions of HCV RNA from baseline to day seven with TMC435 alone and in triple therapy were 2.63 and 3.47 log10 IU/mL, respectively, in the 25 mg arm, and 3.43 and 4.55 log10 IU/mL in the 75 mg arm. In the 75 mg four-week triple therapy arm, no viral breakthrough was observed; 9/9 patients achieved HCV RNA below lower limit of quantification (<25 IU/mL) and 8/9 patients achieved undetectable HCV RNA (<10 IU/mL) at day 28 (RVR=89 percent).

"These data provide important information about an emerging new approach to treating HCV," said Professor and Chairman Michael Manns, Hannover Medical School, Germany. "The discovery and development of new treatments is critical to improving the standard of care for the millions of people living with this disease."

As a global virology leader committed to patient care, Tibotec uses innovative science and expertise to research, develop, and manufacture, drugs for medical conditions with an unmet need. The company has successfully launched two antiviral medications for the treatment of HIV and is now building a portfolio of novel antiviral therapies for HCV with the goal of becoming a prominent leader in the treatment of this infectious disease.

TMC435 was discovered through a drug discovery collaboration between Medivir and Tibotec. Tibotec has the right to develop and commercialize the compound throughout the world, excluding the Nordic countries. In addition to TMC435, Tibotec has another PI in phase III development for the treatment of chronic HCV infection.

"Tibotec is committed to evaluating the safety and efficacy of TMC435 in clinical studies to determine its potential use in people with HCV," said Roger Pomerantz, M.D., president of Tibotec Research and Development. "This is an important step in our mission of addressing treatment challenges of infectious diseases, including HCV, HIV and tuberculosis."


'/>"/>

Contact: Julian Teixeira
julian.teixeira@zenogroup.com
202-965-7808
Zeno Group
Source:Eurekalert

Related medicine news :

1. Tibotec Pharmaceuticals a Respectful Partner to HIV Community in Pricing of Novel New HIV NNRTI, INTELENCE
2. Updated GOLD report presents new understandings in diagnosis, treatment and prevention of COPD
3. The Art Of Maternity(TM) at Destination Maternity(R) Presents A Sacred Passage Into Motherhood; the Art of Belly Masking to Belly Casting
4. Presentation Time Correction: Keryx Biopharmaceuticals Presents at 12:00pm, ET Tomorrow (Oct. 3) at William Blair & Company Small-Cap Growth Stock Conference
5. VNUS Medical Technologies Presents at William Blair Small-Cap Growth Stock Conference
6. NARSAD - Worlds Leading Mental Health Research Charity - Presents 19th Annual New York Mental Health Symposium, Oct. 19th & 20th
7. Retirement Living TV Presents Sex, Drugs and Rock N Roll
8. AviaraDx Presents at 2007 BIOCOM Investor Conference
9. NARSAD - the Worlds Leading Mental Health Research Charity - Presents 2007 Prizes for Outstanding Psychiatric Research at New York Gala, October 19th
10. California Science Center Science Matters Speakers Program Presents The Science and Ethics of Fear
11. Borgata Heart & Soul Foundation Presents Third Annual Women in Wine Event
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now ... of Final Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. ... Final Cut Pro X users can now reveal the media of their split ...
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution is ... emergency ambulance transport experience for the millions of people who require these medical ... the taxi industry through the use of technology. Now, SmartEMS has put forth ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A ... 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, where the ... history as home to some of the world’s leading providers of cereal and other ...
(Date:6/26/2016)... ... , ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop a ... fitness app plans to fix the two major problems leading the fitness industry today:, ... type program , They don’t eliminate all the reasons people quit their exercise ...
(Date:6/25/2016)... ... , ... Austin residents seeking Mohs surgery services, can now turn to Dr. ... Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to include ... in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 2016   Bay Area Lyme Foundation , ... Center for Tick Borne Illness , Harvard Medical ... Hacking Medicine, University of California, Berkeley, and the ... five finalists of Lyme Innovation , the ... 100 scientists, clinicians, researchers, entrepreneurs, and investors from ...
(Date:6/24/2016)... June 24, 2016 The Academy of Managed ... recommendations that would allow biopharmaceutical companies to more ... that make formulary and coverage decisions, a move that ... new medicines. The recommendations address restrictions in ... on the drug label, a prohibition that hinders decision ...
(Date:6/24/2016)... 24, 2016 Research and Markets has ... Companion Diagnostic Tests" report to their offering. ... Diagnostics The World Market for Companion Diagnostics ... diagnostics. Market analysis in the report includes the following: ... Vitro Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
Breaking Medicine Technology: