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Clinical Update - Debio 025 in Hepatitis C
Date:1/26/2009

LAUSANNE, Switzerland, January 26 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, announced today the randomisation of its first patient in a phase IIb clinical study with Debio 025, a selective cyclophilin (Cyp) inhibitor with a potent anti-hepatitis C (HCV) effect. This multinational, double blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of three different treatment regimens combining Debio 025 with Peg interferon alpha 2a (peg-IFNalpha2a) and ribavirin in treatment-naive chronic HCV genotype 1 patients.

During this 72 week trial, on top of the Standard of Care (SOC) treatment consisting of peg-IFNalpha2a 180 microgram once weekly and ribavirin 1000 or 1200 mg/day, patients will receive an oral dose of 600 mg of Debio 025. Three different triple combination regimens will be compared to the SOC treatment. The Company aims to evaluate whether there is an increase in the proportion of patients who achieve a sustained viral response (HCV RNA < 10 U/mL 24 weeks after treatment end) with Debio 025, compared to the SOC treatment. The trial will include 272 treatment-naive chronic HCV genotype 1 patients. Results of the study are expected in Q1 2011.

"We believe that the future of chronic HCV treatment lies in the combination of drugs with different mechanisms of action and potential additive or synergistic antiviral effects. For this reason we are investigating the use of Debio 025 combined with the current peg-IFNalpha2a/ribavirin dual therapy. We are optimistic that this combination will reduce the risk of treatment failure for HCV patients and maximise their chances of sustained viral response," said Rolland-Yves Mauvernay, President and Founder of Debiopharm Group.

"With over 170 million people infected with HCV worldwide, there i
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SOURCE Debiopharm Group
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