Zandaxin Announcement December 2005
September 28, 2005
SciClone to Report Top-Line Data From First U.S. Hepatitis C Phase 3 Trial by Mid-December 2005
SAN MATEO, CA — (MARKET WIRE) — 09/27/2005 — SciClone Pharmaceuticals (NASDAQ: SCLN) today announced that it expects to unblind and report top-line data by mid-December 2005 from the first of its two U.S. phase 3 hepatitis C virus (HCV) clinical trials evaluating its lead compound, ZADAXIN®, as a novel adjunctive treatment for hepatitis C patients who have failed prior therapy. Previously, SciClone planned to unblind the data from both trials together and report these data in the early part of 2006.
“Earlier access to the results from the first trial will provide us with valuable information for the design, prioritization and implementation of additional product development programs, ZADAXIN regulatory plans, marketing strategy and resource allocations,” commented Dr. Ira Lawrence, President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. “SciClone is at a very important point in its history, with final data from this first phase 3 trial available to us by mid-December of this year, as well as preliminary data from a phase 2 malignant melanoma trial run by Sigma-Tau by year-end and final data from the second HCV phase 3 trial released in the early part of 2006.”
SciClone’s two phase 3 hepatitis C trials are designed to determine the benefit of adding ZADAXIN to pegylated interferon alpha to treat hepatitis C non-responder patients. Complementary in design, the first trial enrolled over 500 HCV non-responder patients without liver cirrhosis, while the second trial enrolled over 500 HCV non-responder patients with early liver cirrhosis. Patients in the second trial have completed therapy and will finish their observation period in December 2005. Biopsies for the last patients enrolled in this second trial will be performed by the end of February 2006 and the data from this trial will be reported in the early part of 2006.
“Of course, at this time we cannot predict whether the results from either trial will be favorable or unfavorable,” cautioned Dr. Lawrence. “In general, favorable results from both trials would be needed to proceed with the filing of an NDA.”
SciClone’s two U.S. phase 3 clinical trials are multi-center, randomized and double-blinded studies. All patients in each trial are assigned to a 48-week course of treatment of either ZADAXIN and pegylated interferon alpha or placebo and pegylated interferon alpha. After completing treatment, the patients are followed for a 24-week observation period. The primary endpoints of both trials are the achievement of a sustained virologic response (SVR), defined as the lack of detectable HCV RNA in the bloodstream measured by PCR test 24 weeks after the completion of 48 weeks of therapy, and improvement in liver histology.
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone’s lead product ZADAXIN® is currently being evaluated in two phase 3 hepatitis C clinical trials in the United States and one hepatitis C triple therapy clinical trial in Europe. ZADAXIN also is being evaluated in other late-stage clinical trials for the treatment of hepatitis B and certain cancers. The company’s other principal drug development candidate is SCV-07, currently in phase 1 development, which is being evaluated for the treatment of viral and other infectious diseases. For more information about SciClone, visit www.sciclone.com.
The information in this press release contains forward-looking statements including our expectations regarding the timing of availability of clinical trial data. 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. Actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including unexpected difficulties in compiling or analyzing data, and the availability of information from third parties. as well as other risks and uncertainties described in SciClone’s filings with the Securities and Exchange Commission. The availability of phase 3 trial data, even positive data, by itself, does not ensure that the company can successfully file an NDA or ultimately attain regulatory approval.