- Vertex begins phase Ib hepatitis C trial Messenger

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Tuesday November 9, 04:50 PM

Vertex begins phase Ib hepatitis C trial

Global biotech firm Vertex Pharmaceuticals (NASDAQ: VRTX - news) , a

small-molecule drugs developer, has initiated a phase Ib clinical trial for its

investigational oral protease inhibitor for the treatment of hepatitis C

infection.

Global biotech firm Vertex Pharmaceuticals, a small-molecule drugs

developer, has initiated a phase Ib clinical trial for its investigational oral

protease inhibitor for the treatment of hepatitis C infection.

The double-blind, placebo-controlled study will evaluate the tolerability,

pharmacokinetics and viral kinetics of multiple, ascending doses of VX-950 over

a period of up to 14 days and will enroll approximately 60 subjects. This is the

first reported initiation of a study that involves 14 days of administration of

a hepatitis C virus (HCV) protease inhibitor in patients with chronic hepatitis

C infection.

The clinical study will first assess healthy volunteers receiving multiple

doses of VX-950 for a five-day period. Following this initial assessment, the

study will evaluate three different doses of VX-950 in HCV patients, over 14

days of treatment in serially configured dose groups.

Pre-clinical studies have shown that VX-950 significantly reduces levels

of HCV RNA in both an in vitro replicon system and infectious virus assays. In

the phase Ia clinical study, VX-950 was well-tolerated and demonstrated oral

bioavailability.

Furthermore, combined clinical and pre-clinical pharmacokinetic results

indicate that VX-950 can be administered in a dose regimen that may achieve

liver concentrations substantially greater than target concentrations (IC50 and

IC90 in non-clinical studies).

" The phase Ib study is expected to provide us with important information

on the ability of VX-950 to reduce viral load, which we expect will help to

define the potential clinical impact of this new class of drugs, " said Dr

Alam, senior vice president of drug evaluation and approval at Vertex.

Vertex anticipates that the phase Ib study will be completed in the first

half of 2005.

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