tag:blogger.com,1999:blog-5538539029544017314.post-1869403313688674002008-05-03T08:56:00.000-07:002008-05-03T08:58:24.620-07:00<span class="zemanta-img" style="margin: 1em; display: block; float: right;"><a href="http://en.wikipedia.org/wiki/Image:HCV_genome.png" target="_blank"><img src="http://upload.wikimedia.org/wikipedia/en/thumb/c/c0/HCV_genome.png/202px-HCV_genome.png" alt="Genome organisation of Hepatitis C virus" style="border: medium none ; display: block;"></a><span style="margin: 1em 0pt 0pt; display: block;">Image via <a href="http://en.wikipedia.org/wiki/Image:HCV_genome.png" target="_blank">Wikipedia</a></span></span>Debiopharm Group (Debiopharm), a global independent biopharmaceutical development specialist focusing on serious medical conditions, particularly oncology, presented positive efficacy results of a phase IIa study with Debio 025, a selective cyclophilin (Cyp) inhibitor with a potent in-vitro and in-vivo anti-hepatitis C (<a href="http://en.wikipedia.org/wiki/Hepatitis_C_virus" title="Hepatitis C virus" rel="wikipedia" target="_blank" class="zem_slink">HCV</a>) effect. Data indicates that Debio 025 shows an important additive anti-HCV effect when co-administered with pegylated Interferon (Peg-IFN) alpha-2a to treatment- naive HCV patients.<br /><span id="fullpost"><br /><div id="lw_context_ads"><br />Debiopharm presented these findings at the 43rd Annual Meeting of the European Association for the Study of the Liver, in Milan, Italy.<br /><br />The double-blind, placebo-controlled study investigated different dose regimens of Debio 025 in combination with alpha-2a Peg-IFN 180 Mug/week in treatment naive chronic HCV mono-infected patients. Ninety patients were randomised to receive either of the following treatment regimens during 29 days: Peg-IFN with placebo; Peg-IFN with Debio 025 200 mg/day; Peg-IFN with Debio 025 600 mg/day; Peg-IFN with Debio 025 1000 mg/day; and Debio 025 1000 mg/day.<br /><br />In patients with genotypes 1 and 4, at day 29, the HCV-RNA reduction was -4.6 log10 IU/mL in the Peg-IFN with Debio 025 600 mg/day arm, and -4.8 log10 IU/mL in the Debio 025 1000 mg/day arm. This was significantly different (p&lt; 0.05) from the Peg-IFN with placebo, as well as the Debio 025 1000 mg/day monotherapy arms, in which the reduction in viral load was respectively -2.49 and -2.20. In these two arms, at day 29, the proportion of subjects with undetectable viral load was 25%. This number increased to 66% in the Peg-IFN with Debio 025 1000 mg/day group.<br /><br />"To obtain these exciting results after an administration period of only one month is promising and demonstrates that Debio 025 will be a breakthrough in the treatment of HCV infections," said Kamel Besseghir, CEO of Debiopharm S.A. "This unique mechanism of action is the first alternative treatment to classic HCV therapies."<br /><br />Debio 025<br /><br />Debio 025 is a synthetic first-in-class Cyp inhibitor, being tested in humans as a potential anti-HCV drug. Debio 025 binds strongly to Cyp, host cell proteins thought to confer a replication advantage to HCV. Its potent inhibitory activity on the HCV replication was shown in preclinical studies.<br /><br />Previous results of a phase Ib study demonstrate that Debio 025 monotherapy for 15 days induced a strong anti-HCV effect (3.6 log10 reduction) in HIV-1/HCV co-infected patients. (Hepatology, Vol. 47, No 3, 2008, Flisiak et al. "The Cyclophilin Inhibitor Debio-025 Shows Potent Anti-Hepatitis C Effect in Patients Coinfected with Hepatitis C and Human Immunodeficiency Virus)."<br /></div><br /></span><div id="zemanta-pixie" style="margin: 5px 0pt; width: 100%;"><a id="zemanta-pixie-a" href="http://www.zemanta.com/" title="Zemified by Zemanta"><img id="zemanta-pixie-img" src="http://img.zemanta.com/pixie.png?x-id=d4a8b875-1fde-4b26-b2bd-c327fd310ba4" style="border: medium none ; float: right;"></a></div><div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/5538539029544017314-186940331368867400?l=clinicaltrialsweb.blogspot.com' alt='' /></div>RickyFannoreply@blogger.com0