InterMune, Inc. Initiates Phase 1a Clinical Trial Evaluating Hepatitis C Protease Inhibitor ITMN-191 In Collaboration With Roche
Published: Dec 19, 2006
BRISBANE, Calif., Dec. 19 /PRNewswire-FirstCall/ -- InterMune, Inc. 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.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes two Phase III programs evaluating possible therapeutic candidates for treatment of patients with IPF. The INSPIRE trial is evaluating Actimmune(R) (interferon gamma-1b) and the CAPACITY program is evaluating pirfenidone. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 in Phase 1a, a second-generation HCV protease inhibitor program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to the progress, future patient enrollment in and timing of InterMune's clinical trials and announcements of results thereof. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading 'Risk Factors' in InterMune's annual report on Form 10-K filed with the SEC on March 13, 2006 (the "Form 10-K") and updates included in the most recent Form 10-Q filed with the SEC on November 7, 2006 (the "Form 10-Q"), and other periodic reports filed with the SEC, including the following: (i) risks related to the development of our product and product candidates; (ii) risks related to timely patient enrollment and retention in clinical trials, including the use of third parties to conduct such clinical trials; (iii) risks related to achieving positive clinical trial results; (iv) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues; (v) risks related to our collaboration agreement with Roche; and (vi) risks related to our intellectual property rights. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC.InterMune, Inc.
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