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Clinical Update - Debio 025 Cyclophilin Inhibitor for the Treatment,of HCV

A Unique Viral Kinetics Profile

LAUSANNE, Switzerland, April 19, 2007 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global independent biopharmaceutical development specialist in oncology and serious medical conditions, presented additional results of a previous phase Ib, 15 day study with cyclophilin (Cyp) inhibitor Debio 025 in HIV/HCV (hepatitis C virus) co-infected patients. The data were presented at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain. Mathematical modelling of the viral decay shows that Debio 025 has a unique viral kinetics profile without signs of emerging resistance during short term treatment.

Other data from the same study showed that during treatment, Cyp-B levels decreased significantly in peripheral blood mononuclear cells (PBMCs) after treatment with Debio 025. The drop in Cyp-B levels paralleled the 3.6 log10 decrease reported earlier in this study. These human data confirm previous in vitro results that have shown that Cyp-B inhibition leads to the depletion of intracellular Cyp-B levels in the HCV replicon, as well as in other cell culture models. These are the first preliminary human data that support the hypothesis that intracellular CypB depletion is associated with significant anti-HCV activity and that CypB inhibition is a valid new target for the development of anti-HCV drugs.

"We are very excited about these results. To date, we have finalised the first two cohorts of our phase IIa study in treatment-naive mono-infected HCV patients, where we examined the effect of increasing doses of Debio 025 in combination with pegylated interferon. The Data Management Committee has analysed all safety and efficacy data and authorised the initiation of the cohort with the highest dose in the protocol," said Kamel Besseghir, CEO of Debiopharm S.A.

About Debio 025

Debio 025 is a synthetic first-in-class
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TAG: Clinical Update Debio Cyclophilin Inhibitor for the Treatment HCV
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