OK, guys, take those call writing opportunities when you get 'em. Here's today's:
>>SAN MATEO, Calif., May 21 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq: SCLN - news) announced that a new study presented today at the American Association for the Study of Liver Disease (AASLD) session at the Digestive Disease Week (DDW) meeting in Atlanta showed significantly greater sustained response rates in patients treated with the combination of ZADAXIN®, SciClone's lead immune system enhancer (ISE), and alpha interferon than those in patients treated with alpha interferon alone.
The study was conducted in Turkey in patients with chronic hepatitis B that is anti-HBe-positive, a very difficult to treat patient population infected with the precore mutant of the hepatitis B virus, for which no consistently effective therapy is yet available. This is a highly prevalent type of hepatitis B in Turkey, Italy and other Mediterranean countries.
Twenty-one patients received the combination therapy for 26 weeks, followed by 26 weeks of alpha interferon monotherapy. Ten patients received 52 weeks of alpha interferon monotherapy alone. All patients were observed for an additional 26 weeks without medication to establish clear evidence of a sustained response as opposed to patient relapse which often occurs when anti-viral medication alone is stopped. The trial endpoints were negative HBV DNA and normalization of biochemical markers at weeks 52 and 78. The results demonstrated that the response rate at the end of treatment (week 52) was higher in the combination ZADAXIN plus alpha interferon arm (88 percent) compared to 70 percent in the monotherapy arm. More importantly, the sustained response rate at week 78, which reflects disappearance of the hepatitis B virus from the blood, was statistically significantly higher in the combination group (76 percent) compared to only 40 percent for interferon alpha monotherapy patients. Furthermore, Zadaxin did not add any toxicity to that already known to be associated with alpha interferon.
Investigators concluded, `` ... combining ZADAXIN with alpha interferon may decrease the high relapse rate seen with interferon monotherapy, which is the most important problem in the treatment of anti-HBe-positive chronic hepatitis B.''
``The AASLD at DDW provides an international forum and studies like this can be particularly important for our current ZADAXIN markets,'' said Eduardo Martins, MD, PhD., SciClone's Medical Director. ``In countries where ZADAXIN is approved for hepatitis B, it is positioned as a safer alternative monotherapy to alpha interferon because it produces no serious side effects. However, with data like this, combination regimens using ZADAXIN together with other agents may become more widely used.''
The hepatitis B virus (HBV) is 100 times more infectious than HIV, the virus that causes AIDS. The World Health Organization estimates that approximately 350 million people worldwide are long-term carriers of HBV, including 1,200,000 Americans. The American Liver Foundation estimates that there are 140,000 new HBV infections in the U.S. each year and that one of every 20 people in the U.S. will be infected with HBV in their lifetime. Up to 40% of people with acute HBV infection show no symptoms. Many people chronically infected with HBV will progress to liver cirrhosis and liver failure, from which they will eventually die. People with chronic HBV infection have a 100 times greater chance of developing hepatocellular carcinoma than those not infected. Hepatocellular carcinoma is one of the most prevalent malignant diseases in the world.
ZADAXIN, a synthetic preparation of thymosin alpha 1, a peptide that occurs naturally in humans and is an immune system enhancer (``ISE'') that helps stimulate, maintain and direct the body's antiviral or anticancer responses, has been administered to over 3,000 subjects in over 70 clinical trials covering a broad range of diseases and to many thousands of patients commercially around the world with virtually no serious drug related adverse events or toxicities. ZADAXIN is approved for sale in 24 countries, principally for the treatment of hepatitis B and hepatitis C and as a vaccine adjuvant for patients with weakened immune systems. ZADAXIN is currently in a phase 3 program in the U.S. in combination with Pegasys®, pegylated interferon alfa-2a, for the treatment of hepatitis C, in a phase 2 program in combination with lamivudine for the treatment of hepatitis B and in two phase 2 trials for the treatment of liver cancer. In Europe, a phase 3 ZADAXIN program will be undertaken which would complement the Company's U.S. clinical program. ZADAXIN is also in clinical trials in Japan and Australia.<<
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Cheers, Tuck |
