Vertex Pharmaceuticals to Start Phase 3 'REALIZE' Trial with Telaprevir in Hepatitis C

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Article Summary

Vertex Pharmaceuticals to Start Phase 3 'REALIZE' Trial with Telaprevir in ..

PharmaLive News Archive - 18-Aug-2008

Vertex is on track to complete enrollment of the ADVANCE trial during the fourth

quarter of 2008 and expects to have sustained viral response (SVR) data from the

trial in the first half of 2010. Vertex Pharmaceuticals Incorporated is a global

biotechnology company committed to the discovery and development of breakthrough

small molecule drugs for serious diseases.

Summary

• The trial will be conducted in the U.S. and E.U. and will enroll approximately

650 genotype 1 HCV patients who failed prior treatment with pegylated-interferon

(peg-IFN) and ribavirin (RBV).

• The trial is designed to evaluate two 48-week telaprevir-based regimens in

comparison with a 48-week control arm.

• Telaprevir will be dosed for 12 weeks.

• The primary endpoint of the trial is SVR, defined as undetectable HCV RNA

(less than10 IU/mL) 24 weeks after the completion of treatment.

• " In Phase 2 clinical trials, telaprevir-based regimens have demonstrated the

potential to increase sustained viral response rates across a broad spectrum of

patients infected with the hepatitis C virus, including patients who failed to

achieve SVR with previous pegylated interferon and ribavirin therapy, many of

whom are at high risk for life-threatening HCV-related complications, " said Ira

son, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill

Medical College of Cornell

• University. "

• The REALIZE trial of telaprevir is a landmark Phase 3 trial of an

investigational HCV protease inhibitor in null responder and other patients who

failed prior treatment and will seek to generate additional data to demonstrate

the benefit of telaprevir in this difficult to treat patient population. "

• " Approximately 6 million patients are chronically infected with hepatitis C in

the U.S. and E.U. today, and approximately 650,000 of these patients have failed

previous treatments of pegylated interferon and ribavirin therapy and are in

need of a new therapeutic option to treat their disease, " said Kurt C. Graves,

Vertex's Executive Vice President, Chief Commercial Officer and Head, Strategic

Development.