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Wednesday, December 22, 2010

Vertex halts part of HCV trial

By Michelle Lang

Vertex Pharmaceuticals Inc. is discontinuing part of a Phase 2 clinical trial of its hepatitis C virus (HCV) drug candidate, the company announced in a press release today. The Cambridge biotech halted the second two-drug treatment, which consisted of telaprevir, its investigational HCV protease inhibitor, and VX-222, its investigational HCV polymerase inhibitor, VX-222.

The trial is continuing with three-drug and four-drug treatment regimens.

The discontinued arm of the trial was intended as a 12-week test of a twice-daily combination treatment with telaprevir and VX-222. It was ended due to “meeting a pre-defined stopping rule related to viral breakthrough.”

Vertex ended another two-drug combination trial in October.

In November, Vertex announced it had finished submitting telaprevir for approval by the U.S. Food and Drug Administration. The company’s studies of telaprevir alone showed that up to 75 percent of hepatitis C patients who had never received treatment achieved a viral cure, compared with 44 percent of those treated with existing therapies.

Hepatitis C affects up to 3.9 million people in the United States and can lead to cirrhosis of the liver, liver cancer and the need for liver transplantation.


 

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