Vertex plans to enroll 1,000 hepatitis C patients in VX-950 trials by 2007

By Jennifer Lanning Drey

Eugene, Ore., June 15 - Vertex Pharmaceuticals Inc. plans to have more than 1,000 hepatitis C virus patients enrolled in its VX-950 clinical trials by the first quarter of 2007, according to Lynne Brum, vice president of strategic communications for the company.

"We look at our clinical trial program gaining momentum over the next few months," Brum said during a presentation Thursday at the Needham & Co. Biotechnology and Medical Technology Conference.

Vertex began enrolling patients this week in Prove-1, its U.S. study of investigational oral hepatitis C protease inhibitor, VX-950, she said. The study is expected to involve 260 patients.

Prove-2, a complimentary trial that will study 320 hepatitis C patients on VX-950 in Europe is planned to begin before the end of the quarter. Clinical testing of the drug on an additional 400 patients who have previously failed hepatitis C treatment will begin in the fourth quarter, Brum said Thursday.

The company expects to have its first clinical data from the studies in the fall and its first post-treatment results in 2007.

Vertex is on track to begin phase 3 trials in 2007 and file a New Drug Application by 2008, Brum said.

"Our goal is to transform the treatment of HCV [hepatitis C]," she said.

The company believes the current hepatitis C market in the United States, Japan and the five major markets in Europe to be $8 million.

"HCV is a significant market before we even turn to developing countries or go to estimates that are more aggressive than these," Brum said.

Vertex is currently scaling up manufacturing of the drug and plans to have approximately two tons of the substance available by the end of the year.

The company's ultimate goal is to reach a three-month course of therapy with VX-950.

"We want to give people a better hope of coming up with effective therapy and a short-course therapy," Brum said.

Vertex is a biotechnology company located in Cambridge, Mass., specializing in small molecule drugs.

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