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BRISBANE, Calif. -- InterMune, Inc. announced today that it has initiated a Phase I clinical study to evaluate PEG-Alfacon, the PEGylated version of Infergen (Interferon alfacon-1), as a potential new treatment for chronic hepatitis C virus (HCV). InterMune currently markets Infergen, a bio-engineered type I interferon alpha, for the treatment of patients with chronic hepatitis C infections. PEGylation is a technology designed to chemically modify drugs to decrease dosing frequency and possibly improve drug efficacy and safety.
The Phase I, open-label, dose-ascending study of PEG-Alfacon will enroll approximately 40 healthy volunteers. The study is designed to: i) evaluate the pharmacokinetic and pharmacodynamic characteristics of PEG-Alfacon; ii) determine the maximum tolerated dose of this new chemical entity; and iii) evaluate its safety. The study is being conducted at a center specializing in pharmacokinetic analyses.
"We anticipate that the introduction of PEG-Alfacon will mark the beginning of a new era of HCV therapeutics where more potent bioengineered compounds are used to combat this disease," said Scott Harkonen, president and CEO of InterMune. "We look forward to completing this study and plan to initiate a Phase II dose-ranging study by the end of 2003 to further evaluate PEG-Alfacon in patients."
"We believe that the clinical potential of PEG-Alfacon is extremely promising given that Infergen -- the only bioengineered interferon in the hepatitis C market -- has been shown to have greater interferon receptor binding, and better immune activating and viral inhibition capabilities compared to other alpha interferons," said Dr. Curtis Ruegg, vice president of pre-clinical and process development at InterMune. "We believe the advantages of Infergen and pegylation, when coupled, could result in higher response rates with PEG-Alfacon and ultimately a promising new treatment for the more than four million patients suffering from chronic hepatitis C infections."
Infergen is currently approved for treatment of adult patients with chronic hepatitis C infections, including therapy for patients who have never been treated with interferons and for patients following relapse or non-response to treatment with certain previous treatments. Please visit www.infergen.com for full prescribing information including the black box warning.
PEG-Alfacon is the result of chemical engineering using PEGylation technology to attach a polyethylene glycol (PEG) moiety to the active Infergen molecule. The expected effect of PEGylation is to increase drug circulation time in the bloodstream, decrease the rate of proteolysis by circulating enzymes, and reduce immunogenicity.
InterMune is a commercially driven biopharmaceutical company focused on the marketing, development and applied research of life-saving therapies for pulmonary disease, infectious disease and hepatology.
Source: InterMune, Inc.