Update on Thymalfasin

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From the Projects In Knowledge Editorial Department:

Despite earlier trials that seemed to point in an encouraging direction, final results of a phase 3 trial indicated that thymalfasin in combination with peginterferon alfa-2a is not effective for the treatment of hepatitis C virus (HCV) infection in patients who were prior nonresponders to interferon-based therapy. In this US study, 535 HCV-infected nonresponders received 48 weeks of peginterferon alfa in combination with either thymalfasin or placebo. Four percent (10/269) of patients receiving thymalfasin plus peginterferon achieved sustained virologic response (SVR) compared with 2% (5/265) of patients receiving peginterferon alone, a difference that was not statistically significant. In addition, no statistically significant difference in histologic improvement was observed between the two treatment groups. Although SciClone Pharmaceuticals Inc., the manufacturer of thymalfasin, was ³disappointed that this trial did not achieve statistical significance,² they and their European partner, Sigma-Tau Pharmaceuticals, Inc., will further study these findings as well as those from other ongoing European HCV trials, including a phase 3 triple-therapy study (thymalfasin/peginterferon/ribavirin) in prior peginterferon/ribavirin nonresponders.

For further information, go to:

http://www.sciclone.com/media/archives.php?yr=2005 & date=dec_14

and

http://www.hivandhepatitis.com/hep_c/news/2005/ad/121605_a.html.