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发表于 2004-4-15 23:09
SciClone Pharmaceuticals (SCLN) Explores New Combination Therapy In Hepatitis B Clinical Trial
Trial Uses High Dose of ZADAXIN in Combination with Lamivudine
SAN MATEO, Calif.--(BUSINESS WIRE)--April 14, 2004--SciClone Pharmaceuticals (Nasdaq:SCLN - News) today announced an ongoing randomized placebo-controlled clinical trial in Taiwan using a high dose of ZADAXIN?in combination with lamivudine, the most widely used treatment for chronic hepatitis B, to explore the possibility of increasing the efficacy of current treatment for chronic hepatitis B patients. This SciClone sponsored study is designed to build on both the immunomodulator effects of ZADAXIN and the potent anti-viral capabilities of nucleoside analog drugs such as lamivudine. SciClone holds a granted U.S. patent for the treatment of hepatitis B using ZADAXIN in combination with lamivudine that does not expire until 2018. The primary objective of this study is to demonstrate that patients receiving the ZADAXIN lamivudine combination therapy could achieve a significantly higher sustained response rate than patients receiving lamivudine monotherapy, while limiting the use of lamivudine to one year. Lamivudine has been shown to be very effective in suppressing the hepatitis B virus. However, long-term use of lamivudine has been shown to lead to serious HBV mutations. Viral mutations are seen after one year of lamivudine therapy and the incidence of mutation continues to increase with time reaching approximately 55% after three years. Associated with these mutations is the development of viral resistance to lamivudine making therapy more difficult. In addition, lamivudine's overall efficacy is limited. Data show that lamivudine therapy produces a sustained seroconversion (the disappearance of HBV e-antigen and the detection of the antibody to the HBV e-antigen) in only 16% of Asian patients. A separate study using the latest approved HBV therapy, adefovir dipivoxil, a nucleotide analog with a similar mechanism of action as lamivudine, produced a sustained seroconversion in only 12% of patients. In comparison to these studies, ZADAXIN as a monotherapy in a completed phase 3 clinical trial in Japan has demonstrated a sustained seroconversion in 19% of patients receiving low dose (0.8 mg, twice weekly) ZADAXIN and in 22% of patients receiving standard dose (1.6 mg, twice weekly) ZADAXIN. Patients who achieve a sustained seroconversion are widely considered to be cured of chronic hepatitis B.
In this new combination study one group of patients is receiving a high dose of ZADAXIN (3.2 mg, twice weekly) for six months plus a standard dose of lamivudine (100 mg, once a day) for 12 months. The other group of patients is receiving the same dose of lamivudine (100 mg, once a day) for 12 months plus a placebo. Upon completing the 12 months of therapy, each patient will be followed for a six month observation period. Endpoints of the study are the disappearance of HBV DNA and the achievement of sustained seroconversion. The study is being led by Dr. Yun-Fan Liaw at Chang Gung Memorial Hospital in Taiwan, who plans to enroll by the end of 2004 a total of approximately 120 patients suffering from chronic hepatitis B.
Dr. Yun-Fan Liaw, Professor of Medicine at the Liver Research Unit, Chang Gung University and Memorial Hospital commented, "In this study, we intend to explore the theory that the immunomodulatory effects of ZADAXIN could enhance the immune response of HBV patients thereby achieving higher seroconversion rates for those patients using lamivudine to suppress the hepatitis B virus. We expect to observe a higher response rate from the two drugs combined than from the separate response rates of each drug alone, therefore demonstrating a more effective treatment option for patients suffering from chronic hepatitis B." The hepatitis B virus is one of the world's most prevalent blood borne chronic infectious diseases. The World Health Organization estimates that more than 350 million people worldwide, predominantly in Asia, are chronically infected with the hepatitis B virus.
Combination therapy using ZADAXIN is also being studied in clinical trials with pegylated interferon for the treatment of hepatitis C as well as with the chemotherapy drug decarbazine (DTIC) for the treatment of malignant melanoma. Similar to Dr. Liaw's study, these clinical trials are using ZADAXIN in combination with approved drugs with the objective of achieving higher response rates compared to current therapy. ZADAXIN is a pure synthetic preparation of thymosin alpha 1, a natural substance that circulates in the body and is instrumental in the immune response to fight viral infections and certain cancers. In over six years of commercial use and over a decade of clinical development, ZADAXIN, either used alone or in combination with anti-viral and anticancer drugs, has not produced any reported significant side effects or toxicities. ZADAXIN has been approved for sale by the ministries of health in over 30 countries and is marketed in China and selected other countries outside the U.S. SciClone is targeting to file a New Drug Application in Japan for ZADAXIN as a monotherapy for the treatment of chronic hepatitis B by the end of 2004.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone is currently evaluating its lead product ZADAXIN in several late stage clinical trials, including two phase 3 hepatitis C clinical trials in the U.S., a completed phase 3 hepatitis B clinical trial in Japan, a phase 2 malignant melanoma clinical trial in Europe, two phase 2 liver cancer pilot studies in the U.S., and a hepatitis C triple therapy pilot clinical trial in Mexico. The Company's other principal drug development candidate is SCV-07, a potentially orally available therapeutic to treat viral and infectious diseases. For more information about SciClone, visit www.sciclone.com.
The information in this press release contains forward-looking statements including expectations and beliefs regarding the outcome of the hepatitis B study in Taiwan; the timing, number of patients enrolled and completion of enrollment for the study; the timing of filing of SciClone's Japanese New Drug Application and the fact that the experimental or clinical data described or compared may imply certain actual results in larger patient populations. Words such as "expects," "plans," "believe," "may," "will," "anticipated," "intended" and variations of these words or similar expressions are intended to identify forward-looking statements. In addition, any statements that refer to expectations, goals, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including the progress or failure of the hepatitis B study in Taiwan, the statistical significance of data obtained from the study, unexpected results from the interaction of ZADAXIN in combination with lamivudine, the potential for receipt of data that is inconclusive or contradictory, the speed with which patients are enrolled in the study, competition for enrollment of patients meeting a particular patient profile, ability to enroll a sufficient number of eligible patients to yield statistically significant results, maintenance of the sufficiency and eligibility of the enrolled patient population, unexpected delays in preparation of the Japanese New Drug Application, delays in analyzing and synthesizing data obtained from SciClone's phase 3 hepatitis B clinical trial in Japan, the fact that experimental data and clinical results derived from studies with a limited group of patients may not be predictive of the results of larger studies and the fact that comparisons between clinical trials or studies conducted under varying conditions cannot be relied upon as conclusive evidence as to relative therapeutic benefit, as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission.
Contact:
SciClone Pharmaceuticals Richard A. Waldron, 650-358-3437
Source: SciClone Pharmaceuticals
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