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Published on 5/22/2006 in the Prospect News Biotech Daily.

Vertex: Studies show VX-950 reduces hepatitis C virus to undetectable levels

By E. Janene Geiss

Philadelphia, May 22 - Vertex Pharmaceuticals Inc. said Monday that data show that plasma hepatitis C RNA was reduced to undetectable levels in 100% of the 12 patients with genotype 1 hepatitis C infection that were treated with VX-950, an investigational oral hepatitis C virus protease inhibitor used in combination with pegylated interferon alfa-2a (Pegasys; peg-IFN) and ribavirin for 28 days.

No viral breakthrough was observed in any patient during 28 days of VX-950 dosing, according to a company news release.

All patients completed dosing with no serious adverse events. Adverse events reported are considered typical of pegylated interferon and ribavirin combination therapy, officials said.

All patients enrolled in the 28-day study subsequently received follow-on treatment with pegylated interferon and ribavirin.

Researchers reported Sunday at the Digestive Disease Week meeting that 11 of these patients, or 92%, continue to have no detectable virus in their blood at the end of 12 additional weeks of follow-on pegylated interferon and ribavirin dosing.

The 12th patient was found to have detectable hepatitis C RNA in the week 12, post-VX-950 follow-up sample, with continuing evidence of detectable hepatitis C RNA in subsequent samples. All 12 patients are continuing to receive the treatment.

"These results are highly encouraging for the initiation of future VX-950 studies that seek to evaluate the potential for viral eradication with short duration therapy," Eric Lawitz of Alamo Medical Research in San Antonio, said in the release.

VX-950 is an investigational oral inhibitor of hepatitis C virus protease, an enzyme essential for viral replication, and is one of the most advanced investigational agents that specifically targets hepatitis C.

Vertex is a Cambridge, Mass., biotechnology company that develops small molecule drugs.


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