VANCOUVER, and SAN DIEGO, Dec. 3 /PRNewswire-FirstCall/ - MIGENIX Inc. (TSX: MGI, OTC: MGIFF), a clinical-stage developer of drugs for infectious diseases, has received preliminary four-week interim results from a Phase II viral kinetics study in hepatitis C virus ("HCV") treatment-naive patients which indicate that celgosivir (an oral alpha glucosidase I inhibitor) 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 interim results include 10 patients who had completed 4-weeks of
treatment equally divided between: (i) pegylated interferon (alfa-2b) plus
ribavirin ("PR"); and (ii) celgosivir 400mg QD plus PR ("PRC"). The results
are interim as the study is designed as a 20-patient, 12-week study. The
following is a summary of the preliminary interim four-week results:
- viral kinetics in both treatment groups are similar with a median
reduction in HCV RNA at 4 weeks of 3.5 log(10) vs 3.8 log(10) in the
PRC and PR groups, respectively. The variability of response is wide
with reductions of 5.4 log(10) to 0.8 log(10) and 4.5 log(10) to
2.5 log(10) for the PRC and PR groups, respectively. Virus was
undetectable in one patient who was in the PRC group (none in the PR
- PRC treatment was well tolerated, with both the PRC and PR groups
demonstrating similar tolerability, which is consistent with
observations from prior studies. Gastrointestinal tolerability of the
PRC treatment was slightly better in this study compared to prior
studies. No serious adverse events were reported.
Due to the small number of patients and the high response rate with
standard of care alone, any conclusion about differences in efficacy
between the groups is speculative at this point.
|SOURCE MIGENIX Inc.|
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