Tibotec Begins Enrollment for Phase III Study of Telaprevir

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http://www.therapeuticsdaily.com/news/summary.cfm?id=577726 & channelID=31

Tibotec Begins Enrollment for Phase III Study of Telaprevir, an Investigati..

PharmaLive News Archive - 14-Oct-2008

REALIZE is the first phase III study to evaluate a direct antiviral (or STAT-C)

treatment for HCV in null responder patients. The REALIZE phase III study in

treatment failure patients is part of a comprehensive clinical development

program for telaprevir. 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 for tuberculosis.

Summary

• 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 the treatment of HCV, which may provide a new option

for patients who have failed the current standard of care, " said

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 trial (Re-treatment of Patients with Telaprevir-based Regimen to 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 (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:

[Guest guest]

http://www.therapeuticsdaily.com/news/summary.cfm?id=577726 & channelID=31

Tibotec Begins Enrollment for Phase III Study of Telaprevir, an Investigati..

PharmaLive News Archive - 14-Oct-2008

REALIZE is the first phase III study to evaluate a direct antiviral (or STAT-C)

treatment for HCV in null responder patients. The REALIZE phase III study in

treatment failure patients is part of a comprehensive clinical development

program for telaprevir. 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 for tuberculosis.

Summary

• 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 the treatment of HCV, which may provide a new option

for patients who have failed the current standard of care, " said

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 trial (Re-treatment of Patients with Telaprevir-based Regimen to 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 (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: