Tibotec Advances Global Clinical Research Program for TMC435 in HCV; Will Present Four Abstracts Evaluating Safety and Efficacy at EASL

-Company Recently Launched Phase III Studies of TMC435 in Treatment-Naive HCV Patients in 12 Countries-

CORK, Ireland, March 29, 2011 /PRNewswire/ -- Tibotec Pharmaceuticals announced today that four abstracts reporting research findings with TMC435, the company's investigational hepatitis C protease inhibitor, have been accepted for presentation at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany, March 30 to April 3, 2011.  

The four abstracts for TMC435 support Tibotec's continued efforts to advance its research and development program for the treatment of HCV.  TMC435 highlights at the meeting include one oral presentation and one late-breaker poster presentation:

  • Analysis of the predictive nature of IL28B genotype and pretreatment serum IP-10 in treatment-naive HCV patients from phase IIb PILLAR study on TMC435 administered with pegIFN/ribavirin
  • Results from interim 24 week data of the international phase IIb randomized, double-blind, placebo-controlled ASPIRE study on efficacy, tolerability, safety, and pharmacokinetics of TMC435 administered with pegIFN/ribavirin in treatment-experienced HCV patients

"Tibotec is committed to developing innovative new treatment options that may offer better treatment outcomes and that may decrease the duration of treatment for patients with chronic hepatitis C infection," said Brian Woodfall M.D., Vice President of Global Clinical Development at Tibotec. "The company's presence at this year's EASL meeting and the recent launch of the phase 3 clinical trial program for TMC435 reinforce the value of this investigational agent in our growing HCV pipeline."

The titles of the abstracts and times for Tibotec's presentations on TMC435 appear below – full abstracts can also be accessed at www.easl.eu.

Oral Presentation:

  • "Impact of IL28B genotype and pretreatment serum IP-10 in treatment-naive genotype-1 HCV patients treated with TMC435 in combination with peginterferon alpha-2a and ribavirin in PILLAR study" – Thursday, March 31, 2011 from 17:00 to 19:00

Poster Presentations:

  • Late-breaker "The ASPIRE trial: TMC435 in treatment-experienced patients with genotype-1 HCV infection who have failed previous PEG/RBV treatment" – Thursday, March 31, 2011 to Saturday, April 2, 2011
  • "Pharmacokinetics of TMC435 in subjects with moderate hepatic impairment" – Thursday, March 31, 2011 from 09:00 to 18:00
  • "Treatment outcome and resistance analysis in HCV genotype-1 patients previously exposed to TMC435 monotherapy and re-treated with TMC435 in combination with pegIFNalpha-2a/ribavirin" – Saturday, April 2, 2011 from 09:00 to 18:00

About HCV

HCV is a blood-borne infectious disease that affects the liver. With an estimated 170 million people infected worldwide and three to four million people newly infected each year, HCV puts a significant burden on patients and society. Chronic infection with HCV can lead to liver cancer and other serious and fatal liver diseases, and is the most common cause of liver transplant worldwide.  The current standard of care for HCV, pegylated interferon combined with ribavirin, causes serious side effects and only cures 40 to 50 percent of genotype 1 patients. The development of new therapies, particularly direct antivirals with different modes of action, may allow HCV patients to undergo a shorter and more effective treatment regimen.

About Tibotec Pharmaceuticals

Tibotec Pharmaceuticals is a global pharmaceutical and research development company and one of the companies that compose the Janssen Pharmaceutical Companies of Johnson & Johnson. The Company's main research and development facilities are in Beerse, Belgium with offices in Titusville, NJ 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.

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SOURCE Tibotec Pharmaceuticals

 

Posted: March 2011

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