Monday, October 25, 2010

Vertex Update: The Is Busily "Spinning" A Small Phase IIb Study Anomaly

Adam Feurestein, writing for, is working himself into a lather tonight -- over a very small Phase IIb study's Hep C viral rebound in one very low dose arm of a Vertex Telaprevir® study.

"Methinks the lady doth protest too greatly. . . ." In any event, here is a snippet from his report -- do go read it all:

. . . .A phase IIb study combining two of the company's experimental hepatitis C drugs -- VX-222 and telaprevir -- had to be modified after viral loads in some patients rebounded during the first four weeks of treatment. The adversely affected patients were being treated with a low-dose of VX-222 plus telaprevir. . . .

The future of hepatitis C treatment is in the combination of new drugs that act powerfully and directly against the virus, eliminating the need for. . . older, established drugs like [legacy Schering-Plough's, now New Merck's] long-acting interferons and ribavirin which work in less than half of patients. . . .

Vertex said on a conference call that viral breakthrough in the low-dose VX-222/telaprevir arm of the study was not accompanied by any safety issues. Patients continue to be treated with a high-dose VX-222-telaprevir combination, also without safety issues. None of the patients in the remaining three arms of the 100-patient study have experienced viral breakthrough, the company said. . . .

As I say, I suspect this will amount to. . . a whole lot of nuthin'. The now-replicated results of multiple Vertex clincial trials point to a better than 75 percent Hep C cure rate in people on these higher doses of Telaprevir.

But I will keep you informed -- either way.

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