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Clinical Update - Debio 025 in Hepatitis C
Date:4/28/2009

LAUSANNE, Switzerland, April 28 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions, particularly in the field of oncology, presented results from a phase IIa study with Debio 025, a selective cyclophilin (Cyp) inhibitor with a potent anti-hepatitis C (HCV) effect. Revealed at the 44th Annual Meeting of the European Association for the Study of the Liver, in Copenhagen, these findings showed potent antiviral activity.

The phase IIa study investigated the efficacy and safety of Debio 025 in combination with Peg interferon alpha 2a (peg-IFNÿ±2a) and ribavirin in previously null-responder genotype 1 HCV patients. Results demonstrated that Debio 025 at doses of 400 mg (with initial loading) and 800 mg daily for 29 days shows a statistically significant reduction of HCV RNA of respectively -1.96 log (-98.9%) and -2.38 log (-99.5%) when co-administered with Peg-IFN alpha-2a and ribavirin in previous null responders.

"These results in patients who are highly unlikely to respond to re-treatment with an interferon-based regimen, are very important to us, as they confirm that Debio 025 is a potent anti-HCV agent," said Rolland-Yves Mauvernay, President and Founder of Debiopharm Group. "We are making it our mission to find a cure for this widely spread and life threatening disease and these findings bring us one step closer to our goal."

About the phase IIa triple therapy study

Debiopharm investigated different dosing regimens of Debio 025 in combination with peg-IFNÿ±2a at 180 micrograms/week and ribavirin at 1000/1200 mg/day in genotype 1 chronic HCV patients that were previously null responders (< 2 log10 HCV-RNA reduction after 12 weeks with peg-IFN(alpha) 2a and ribavirin). Fifty patients were randomised in an open phase IIa study to receive one of five treatment regimens for 29 days. Afterw
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SOURCE Debiopharm Group
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