Medivir AB (MVRBF.PK) said that a phase II combination study with the investigational compound TMC435 and Bristol-Myers Squibb's (BMY: Quote) investigational compound daclatasvir will start in July. This study is part of the clinical collaboration agreement between Janssen R&D Ireland and Bristol-Myers Squibb announced on December 2, 2011 and on April 18, 2012.
The purpose of the study is to assess the efficacy and safety of TMC435 and daclatasvir in combination with or without Ribavirin in chronic genotype-1 hepatitis C infected patients who are treatment-naive or null responders to previous Peginterferon alfa/Ribavirin therapy.
In this open label phase II study the potential to achieve sustained viral response, or SVR, 12 (SVR12) and 24 (SVR24) weeks post treatment in treatment-naïve and null responder patients infected with HCV genotype 1a and 1b will be evaluated. Patients with advanced liver disease will be allowed up to about 35% of the total treated population.
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by RTT Staff Writer
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