First Clinical Trial With Investigational Agent Telaprevir Phase II Open Label Study In Treatment-Naïve Chronic Hepatitis C Patients

Main Category: Liver Disease / Hepatitis
Also Included In: Clinical Trials / Drug Trials
Article Date: 11 Nov 2007 - 8:00 PDT

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Tibotec BVBA announced that it has opened 5 trial sites in Belgium and Germany in its first clinical study of telaprevir (VX-950) an investigational protease inhibitor (PI) for the treatment of chronic hepatitis C (HCV) infection. The phase II study will open shortly in France, Italy, the Netherlands and Spain, subject to the necessary approvals.

VX-950-C208 is a randomized, open-label, exploratory phase II study in treatment-naïve patients with chronic genotype-1 HCV infection to investigate the efficacy, safety, viral kinetics and pharmacokinetic/pharmacodynamic relationship of different treatment combinations of telaprevir. Patients will be randomized to one of four treatment arms and will receive either 1125 mg telaprevir every 12 hours or 750 mg telaprevir every 8 hours for 12 weeks in combination with standard therapy, either Pegasys® + Copegus® (peg interferon alfa-2a + ribavirin) or Pegintron™ + Rebetol® (peginterferon alfa-2b + ribavirin), which will be given for at least 24 weeks and up to 48 weeks depending on individual virologic response. The total daily dose of telaprevir will be the same in all treatment arms. A total of 160 patients will be enrolled. Telaprevir is an investigational oral inhibitor of HCV protease, an enzyme essential for viral replication, and is one of the most advanced investigational agents in development that specifically targets HCV.

For more about information on the study, visit http://www.clinicaltrials.gov.

"Despite treatment advancements in the last 10 years, there is still an urgent need for new therapeutic options for chronic hepatitis C - especially those compounds that prevent viral replication," said Roger Pomerantz, M.D., President of Tibotec Research and Development.

Tibotec is jointly developing telaprevir with Vertex and has the exclusive rights to telaprevir in Europe, South America, Middle East, Africa and Australia. Vertex is conducting a global Phase 2b clinical development program for telaprevir consisting of three large clinical trials, PROVE 1, 2 and 3, that have enrolled approximately 1,000 patients with genotype-1 HCV at clinical centers in the United States, Canada and Europe.

6 abstracts submitted by Vertex on telaprevir were presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), November 2-6, 2007 in Boston, including presentations of interim data from PROVE 1 and PROVE 2.

About Tibotec

Tibotec BVBA, is a pharmaceutical research and 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 drugs and anti-infectives for diseases of high unmet medical need.

Pegasys® and Copegus® are registered trademarks of Hoffman-La Roche

Pegintron™ and Rebetol® are registered trademarks of Schering Corporation

http://www.tibotec.com