>>SAN MATEO, Calif., Aug. 22 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq: SCLN - news) today announced that the Company has completed enrollment for its phase 3 monotherapy hepatitis B trial in Japan, the second largest pharmaceutical market in the world, with ZADAXIN®, the Company's lead immune system enhancer (ISE) drug.
The study involves over 300 patients with chronic hepatitis B infection. The Company believes the study is currently one of the largest randomized, double-blind clinical trial using ZADAXIN to date. This trial is designed with a six month treatment period followed by a 12 month long evaluation to specifically address the issue of patient relapse which has been seen in other chronic hepatitis B treatments after therapy is stopped. Measuring the endpoints of HBV DNA negativity and improvement in ALT levels following this 12 month evaluation period allows us to rigorously assess whether response to six month ZADAXIN therapy is sustained and durable. The final patients are now receiving the six month therapy. The majority of patients have already completed therapy and follow-up. This phase 3 clinical trial is sponsored by the Company's wholly owned subsidiary, SciClone Japan K.K.
``Based on a study design that resulted in ZADAXIN approvals in 24 countries and reflecting the dosage regimen currently used in commercial sales around the world, this 300 plus patient study is expected to significantly add to the utility and viability of our existing ZADAXIN hepatitis B data base,'' said Donald R. Sellers, SciClone's President and Chief Executive Officer. ``I am proud that SciClone is demonstrating real progress in Japan as well as managing our U.S. hepatitis C ZADAXIN phase 3 program. We anticipate that a ZADAXIN European phase 3 program will commence in the near future.''
Chronic hepatitis B is one of the most common chronic infectious diseases in the world. According to the American Liver Foundation the hepatitis B virus (HBV) is much more infectious than HIV, the virus that causes AIDS. The World Health Organization estimates that there are approximately 350 million chronic carriers of the hepatitis B virus. As stated in a Datamonitor report, there are an estimated 31.5 million carriers of HBV in Japan, of which approximately 10% are chronically infected. Carriers of the hepatitis B virus have a 200-fold increased chance of developing primary liver cancer, the most common cancer in the world, and a significant number develop cirrhosis of the liver.
We have initiated a phase 3 clinical program in the U.S. for the treatment of hepatitis C using ZADAXIN as part of a combination therapy with Pegasys®, pegylated interferon alfa-2a, a proprietary product of F. Hoffmann-La Roche Ltd. In addition, ZADAXIN is in two phase 2 clinical trials in the U.S. for the treatment of liver cancer and in a phase 2 clinical program in combination with lamivudine for the treatment of hepatitis B. A ZADAXIN phase 3 clinical program for European marketing registration currently is being planned for one or more indications that complement the Company's U.S. clinical program. ZADAXIN is also in clinical trials in Japan and in Australia.<<
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