VANCOUVER and SAN DIEGO, Jan. 31 /PRNewswire-FirstCall/ - MIGENIX Inc. (TSX: MGI, OTC: MGIFF), a clinical-stage developer of drugs for infectious diseases, will add a 600mg celgosivir combination therapy arm to its currently enrolling Phase II viral kinetics study in hepatitis C virus ("HCV") treatment-naive patients. The protocol amendment to this study has received Health Canada and Institutional Review Board (IRB) approvals. The purpose of this new treatment arm is to assess 600mg celgosivir (an oral alpha glucosidase I inhibitor) for tolerability, pharmacokinetics and viral kinetics when combined with the standard of care drugs, pegylated interferon plus ribavirin, as compared to the standard of care drugs alone and to 400mg celgosivir plus the standard of care for up to 12 weeks of therapy.
AnnKatrin Petersen, M.D., VP Clinical Development for MIGENIX commented, "The favorable tolerability experienced to date with 400mg per day of celgosivir in triple combination with pegylated interferon plus ribavirin, along with the clinically significant benefit demonstrated in our previous non-responder study, gives us confidence that increasing the dose to 600mg per day in combination therapy is an important development step for the optimization and advancement of celgosivir."
The currently enrolling Phase II viral kinetics study is a 12-week
randomized, active-controlled study initially planned to enroll up to 20
patients in two treatment arms: (i) celgosivir (400mg once daily) plus
peginterferon alfa-2b plus ribavirin ("PRC"); and (ii) peginterferon
alfa-2b plus ribavirin ("PR"). Tolerability, pharmacokinetics and viral
kinetics are being evaluated in the trial. The approved protocol amendment
allows for the addition of a 600mg once daily dosing arm and the
flexibility to increase the total number of patients in the study up to 50.
With 15 patients enrolled to date, it is planned that approximately six
additional patients will be enrolled, all in th
|SOURCE MIGENIX Inc.|
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