MIGENIX Reports Preliminary Celgosivir Viral Kine...( VANCOUVER and SAN DIEGO Dec. 3 / ...),Health

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

group).

- 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.
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