Oral interferon-alpha lozenges: Phase II data

Vita's CytoPharm Inc. subsidiary and Amarillo reported data from a double-blind, Taiwanese Phase II trial in 169 patients with HCV genotype 1b infection showing that there were no differences in virologic relapse rates, the primary endpoint, at week 48 between the 500 or 1,500 IU/day dose groups of oral interferon-alpha lozenges for 24 weeks followed by 24 weeks of untreated observation and placebo. However, in patients with mild liver fibrosis at baseline (n=about 40%), low-dose lozenges reduced the rate of virologic relapse at week 48 by 63% vs. placebo (12% vs. 32%). In the overall population, low-dose lozenges significantly increased mean platelet counts from baseline to weeks 24, 36 and 48 vs. placebo. High-dose lozenges did not significantly improve platelet counts vs. placebo. Additionally, 81% of patients with a low baseline platelet count who received low-dose lozenges achieved a normalized platelet count at week 48 vs. 42% for placebo. All patients in the trial were in viral remission after completing >=24 weeks of peginterferon alfa-2a and ribavirin. The data were submitted for presentation at the American Association for the Study of Liver Diseases meeting in Boston in November. The partners said the data will need to be verified in Phase III trials, but did not disclose details. ...