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VANCOUVER and SAN DIEGO, CA, April 11, 2007 /PRNewswire-FirstCall/ - MIGENIX Inc. , a clinical-stage developer of drugs for infectious diseases, has received new top-line results confirming the previously announced clinical results (November 6, 2006) indicating evidence of clinical benefit, safety and tolerability in a Phase II study using the oral alpha-glucosidase inhibitor, celgosivir (MX-3253), in combination with pegylated interferon and ribavirin.
In addition to confirming the overall conclusions of the original study analysis, retesting resulted in a larger percentage of patients achieving an Early Virologic Response(x) ("EVR") rate with celgosivir plus peginterferon alfa-2b and ribavirin (the "triple combination") as compared to treatment with peginterferon alfa-2b and ribavirin alone (the "control treatment") in patients with chronic hepatitis C virus genotype 1 infections who were characterized as non-responders to prior therapy with optimized pegylated interferon plus ribavirin, achieving:
- 42% (5/12) EVR with the celgosivir triple combination arm compared to
10% (1/10) EVR in the control treatment arm. This compares with 33%
(4/12) EVR (triple combination) vs 10% (1/10) (control treatment) in
the original study results. (x) EVR = 2 log(10) or greater
HCV viral load reduction at 12 weeks.
- 1.63 log(10) (triple combination) mean HCV viral load reduction
("VLR") compared to a 0.92 log(10) VLR (control treatment). This
compares with a 1.2 log(10) VLR (triple combination) vs a 0.4 log(10)
VLR (control treatment) in the original study results.
- a more rapid onset of treatment effect as measured by VLR within the
first 2 weeks of therapy in the triple combination as compared to the
control treatment.
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