To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: The Philippines Approves Zadaxin (Thymalfasin) As Cancer Treatment URL: http://www.pslgroup.com/dg/2019B6.htm Doctor's Guide July 23, 2001
SAN MATEO, CA -- July 23, 2001 -- SciClone Pharmaceuticals today announced that Zadaxin® (Thymalfasin), the Company's lead immune system enhancer (ISE) drug, has been approved in the Philippines as an adjuvant to chemotherapy for the treatment of various cancers. Zadaxin previously was approved in the Philippines for the treatment of both hepatitis C and hepatitis B. This marks the first time Zadaxin has been approved specifically for cancer treatment, although in some countries Zadaxin has been approved for use as an immune system enhancer (ISE) drug without limitation to specific indications. The cancer approval was based on previously reported clinical studies conducted by investigators both in the United States and in Italy. "Clearly, our U.S. hepatitis C phase III program is currently the lead corporate imperative, but it is gratifying to receive the first specific regulatory recognition of the ongoing clinical and scientific work that is focused on using Zadaxin to treat certain cancers," said Donald R. Sellers, SciClone's President and Chief Executive Officer. "The development of Zadaxin's cancer therapy related clinical experience data and safety base is a growing effort." Mr. Sellers also noted that Zadaxin is currently being used in two company-sponsored phase II U.S. trials for liver cancer, one in combination with transarterial chemoembolization (TACE) and one using radio frequency ablation (RFA), the most widely used procedures for liver tumors that are no longer amenable to surgical resection or liver transplantation. A trial is also underway in Australia using Zadaxin in a pure immunotherapy combination regimen for the treatment of advanced malignant melanoma. Zadaxin is 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. It 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 also in certain countries as a vaccine adjuvant for patients with weakened immune systems and as an adjuvant to chemotherapy for the treatment of various cancers. Zadaxin currently is in a phase III program in the U.S. in combination with Pegasys® (pegylated interferon alfa-2a) for the treatment of hepatitis C; a phase II program in combination with lamivudine for the treatment of hepatitis B; and in two phase II trials for the treatment of liver cancer. A phase III Zadaxin 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 Australia. SOURCE: SciClone Pharmaceuticals Related Link: SciClone Pharmaceuticals. --------------------------------------------------------------------------------------------- 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.