Vertex expects to achieve first milestones in Prove trials in Q4

By Jennifer Lanning Drey

Eugene, Ore., Sept. 21 - Vertex Pharmaceuticals Inc. will begin reaching milestones in the fourth quarter related to the phase 2 Prove clinical trials of VX-950 for treatment of the hepatitis C virus, Ian Smith, Vertex's chief financial officer, said Thursday at the Merrill Lynch global pharmaceutical, biotech & medtech conference.

The first of the milestones is expected late in the fourth quarter when the company believes it will have end-of-treatment data for 80 patients who participated in the first cohort of the Prove 1 trial.

Prove 1 is a four-arm, 260-patient study of VX-950, which is an investigational oral hepatitis C virus protease inhibitor. The company believes the drug will demonstrate reduced treatment times and improved viral cure rates over the current standard of care for the virus.

"We have a tremendous opportunity with VX-950 - the opportunity to reduce the current standard of care from 12 months to potentially as short as three months. VX-950, based on the data we've seen so far provides that opportunity," Smith said.

In the first quarter of 2007, the company also expects to have sustained biochemical response (SBR) data for a three-month arm of patients in the Prove 1 trial. That data will be followed by data from a six-month arm in the second quarter, Smith said.

Also in the fourth quarter, the company expects to complete enrollment in the Prove 2 trial, which is similar to Prove 1 and being conducted with 320 patients in Europe.

Prove 3, a study of VX-950 in more than 400 treatment-failure patients, is also expected to begin in the fourth quarter, he said.

As the studies progress, Vertex is on track to begin phase 3 clinical trials of VX-950 in 2007. Data dependent, the company plans to file a New Drug Application in 2008. However, particularly strong data could advance the process more quickly, Smith said.

"If we have tremendous data in the Prove studies, we would have the opportunity to go and discuss with the FDA if there is an alternative path," he said.

Vertex is also planning label expansions for VX-950 and plans to study different genotypes and patients co-infected with the hepatitis C virus and other diseases such as HIV.

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

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