MIGENIX Reports Second Quarter Fiscal Year 2008 Financi...(ion with the Phase II non-responder stud...)

Date:12/13/2007

ion with the Phase II non-responder study described above, a protocol was designed and approved by Health Canada to provide participants in the 12-week study with access to continued treatment for up to an additional 36 weeks (for up to a total of 48 weeks of therapy). In consultation with their physicians, patients could elect to continue on with their original treatment or, if on the double combination or the control treatments, could switch to the triple combination treatment. Of the 50 patients completing 12 weeks of treatment, 31 elected to continue treatment beyond 16 weeks, with 30 of these either continuing with, or switching to, the triple combination and one patient remaining on double combination. Of the 30 patients receiving triple combination treatment: 11 patients completed 48 weeks of treatment with 5 of these patients achieving undetectable virus levels. Three of these patients (all partial responders to prior therapy) relapsed subsequently, and two of the patients (both non-responders to prior therapy) achieved a sustained virologic response (SVR). The safety profile for patients exposed to celgosivir for up to 48 weeks did not differ from those in the initial 12-weeks of treatment. There was no increase in reported diarrhea with long term treatment, nor an increase in incidence and severity of Creatine Kinase (CK) elevations (two side effects seen in previous studies). No new, previously unknown adverse events were reported.

Interim 4-week results on the first 10 patients in an ongoing Phase II viral kinetics combination study of celgosivir in patients with chronic HCV (genotype 1) infection who have not received prior treatment for their infection were announced December 3, 2007. The results indicate that celgosivir has no negative effects on the 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. The viral kine
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SOURCE MIGENIX Inc. Copyright©2007 PR Newswire. All rights reserved

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