SciClone Pharmaceuticals Announces Positive Preliminary Data From Phase 3 Hepatitis B Trial in Japan
SAN MATEO, Calif., Mar 5, 2002 /PRNewswire-FirstCall via COMTEX/ -- SciClone Pharmaceuticals (Nasdaq: SCLN chart, msgs) today announced positive preliminary data from its phase 3 clinical trial in Japan using ZADAXIN as a monotherapy treatment for hepatitis B. Preliminary data on approximately one-third of the 319 patients indicate that, after 6 months of therapy and 12 months of follow up, 24% demonstrated a successful interruption of viral replication, as measured by sustained seroconversion of hepatitis B e-antigen (loss of HBeAg and the development of antibody to HBeAg). By comparison, published data on lamivudine, the drug most widely used for treatment of hepatitis B worldwide, indicate that lamivudine is capable of inducing sustained HBeAg seroconversion in 16% of Asian patients that took the drug for one year.
"We are very pleased by this preliminary data from our phase 3 hepatitis B clinical trial in Japan and expect the remaining patients to complete therapy and follow up by the end of this year," said Eduardo Martins, Medical Director of SciClone. "We continue to make progress towards our goal of bringing ZADAXIN to the major pharmaceutical markets of the U.S., Europe and Japan. We are on target to start enrollment for our U.S. phase 3 hepatitis C clinical trials next month."
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BTW - the testing is being performed with Intron-A, the new PEGintron has not been tested with this drug yet. |
