InterMune Initiates Phase 1a Clinical Trial Evaluating Hepatitis C Protease Inhi

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InterMune Initiates Phase 1a Clinical Trial Evaluating Hepatitis C

Protease Inhibitor ITMN-191 in Collaboration with Roche

December 20, 2006 - 1:21 PM

http://www.drugnewswire.com

BRISBANE, Calif., Dec. 19 /PRNewswire-FirstCall/ -- InterMune, Inc.

(NASDAQ:ITMN) announced today that the company and its partner Roche

have received approval of the European Clinical Trial Authorization

(CTA) for ITMN-191, the NS3/4A protease inhibitor, and have initiated

a Phase 1a clinical trial evaluating ITMN-191 for the treatment of

chronic hepatitis C virus (HCV) infection. The Phase 1a trial will

assess safety, tolerability, pharmacokinetics and food affect in a

double-blind, placebo-controlled single ascending dose study. The

study is being conducted at one clinical trial site in Europe and

will enroll approximately 74 healthy volunteers. InterMune expects to

dose the first patient with ITMN-191 sometime in early January 2007.

" Our preclinical research indicates ITMN-191 has the potential to be

an important addition to therapy for HCV patients because of its

favorable cross resistance and potency profiles, as well as

pharmacokinetic results that support the exploration of twice-daily

oral dosing in future clinical trials, " said Lawrence M. Blatt,

Ph.D., Chief Scientific Officer of InterMune. " The initiation of the

Phase 1a human trial for ITMN-191 moves our HCV protease inhibitor

program one step closer to the proof-of-concept Phase 1b clinical

study in patients infected with HCV. We look forward to providing

updates as we advance the program with our partner Roche. "

About HCV and HCV Protease Inhibitors

According to the Centers for Disease Control and Prevention (CDC), an

estimated 3.9 million Americans (1.8%) have been infected with HCV,

of whom 2.7 million are chronically infected. According to the World

Health Organization (WHO), it is estimated that there are 170 million

people worldwide afflicted with this disease. Currently available

therapies are insufficient, creating a need for the development of

novel therapeutic approaches. The HCV NS3/4A protease is an

attractive drug target because of its potential involvement in viral

replication and suppressive effects on host response to viral

infection. Inhibitors of the HCV protease, such as ITMN-191,

represent a promising new class of drugs for HCV.