To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: AASLD: Zadaxin (Thymalfasin) Activates T-Cells In Hepatitis B Treatment URL: http://www.pslgroup.com/dg/1E8EAA.htm Doctor's Guide October 31, 2000
SAN MATEO, CA -- October 31, 2000 -- SciClone Pharmaceuticals announced that a new study presented at the 51st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Dallas further confirms Zadaxin's® (thymalfasin) powerful ability to activate T-cells (disease fighting white blood cells) and helps explain the fundamental role the Company's Zadaxin immunotherapy plays in the successful treatment of chronic hepatitis B. In the study, conducted by leading researchers at National University Hospital in Singapore, specific T-cell subsets were analyzed among both responders and non-responders to therapy with Zadaxin and alpha interferon. Responders were defined by hepatitis B e-antigen seroconversion and clearance of viral DNA. T-cell analyses were conducted both before and after a six-month treatment regimen. Healthy volunteers were used as controls. Prior to treatment, the only difference in T-cell subsets between controls and hepatitis B patients was a decreased level of activated T-cells in the infected patients. Among responders to treatment, there was a significant increase in T-cell activation and in both CD4 and CD8 T-cell levels compared to pre-treatment levels. Absolute cytotoxic T-cell levels also increased. No such differences were seen in non-responders to therapy. The investigators concluded that increased T-cell activation and specific T-cell subsets are discriminators between successful and unsuccessful therapy in chronic hepatitis B, and that Zadaxin significantly contributed to this increase in the immune response. Preliminary data from this study in Asian patients, a population known to be difficult-to-treat, suggest that sustained responses will be seen in more than 60 percent of patients. Investigators also noted that while seroconversion is considered one of the hallmarks of successful chronic hepatitis B therapy, it has been poorly understood immunologically. "Previous studies have shown that an important biological function of Zadaxin is to enhance the maturation and differentiation of stem cells into T- cells and now we can directly correlate that activity with a measurable therapeutic discriminator in hepatitis," said Alfred R. Rudolph, SciClone's Chief Operating Officer. "We know from clinical and commercial experience in thousands of patients that Zadaxin works as an immune system enhancer and antiviral agent for hepatitis B; this study helps us better understand precisely how and why it works." Zadaxin, a synthetic protein that enhances the immune system, has been administered to over 3,000 subjects in over 70 clinical trials covering a broad range of diseases, and an estimated 7,000 patients commercially, with virtually no serious drug related side effects or toxicities. Zadaxin is approved for sale in 20 countries, principally for the treatment of hepatitis B and hepatitis C and as a vaccine adjuvant for patients with weakened immune systems. In the U.S., where SciClone retains all Zadaxin rights, a pivotal phase 3 Zadaxin hepatitis C program and two phase 2 Zadaxin cancer programs (liver cancer and malignant melanoma) are scheduled to start by the end of the year. Zadaxin is currently in a phase 2 program in the U.S. in combination with lamivudine for the treatment of hepatitis B. In Europe, where SciClone has exclusively partnered with Sigma-Tau S.p.A., a pivotal phase 3 Zadaxin hepatitis C program is scheduled to start by year-end and will complement the Company's U.S. hepatitis C program. In Japan, where SciClone has exclusively partnered with Schering-Plough, K.K., Zadaxin is in a pivotal phase 3 program for hepatitis B and a phase 2 program for hepatitis C. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.