An experimental hepatitis C drug from Vertex Pharmaceuticals (VRTX Quote) can knock back the virus even in the most difficult-to-treat patients, according to results from a clinical trial announced Monday.
The news sent Vertex shares up 63 cents, or 2%, to $32.87 in recent trading Monday morning. The Vertex drug, telaprevir, was able to reduce levels of the hepatitis C virus down to undetectable levels in 52% of so called non-responder or relapse patients. These are patients considered the hardest to treat because they either did not respond to current drugs like interferon and ribavirin, or their virus returned after treatment. Based on previous studies, roughly 10% of treatment-resistant hepatitis C patients who are then retreated with interferon and ribavirin are successfully cured of their disease. The new data on telaprevir come from the PROVE 3 study, a phase II clinical trial that enrolled 453 hepatitis C patients who failed to respond to prior treatment. This is an interim analysis, which means that, to date, telaprevir patients have only been followed for 12 weeks post-treatment. A hepatitis C patient is not considered "cured" of the disease until they have undetectable viral levels 24 weeks, or six months, after treatment.A Race for Market Share
Based on these results, Vertex and partner Johnson & Johnson (JNJ Quote) said Monday that they will start a pivotal phase III study in treatment-failure patients during the third quarter. There has been great market speculation whether Vertex might be able to seek regulatory approval for telaprevir based on PROVE 3 data alone, however.- Loading Comments...
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