|
SciClone Pharmaceuticals and Sigma-Tau today announced that all 553 enrolled patients successfully completed a Phase 3 trial
FOSTER CITY, CA, USA | JunE 26, 2008 | SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) and Sigma-Tau S.p.A. today announced that all 553 enrolled patients successfully completed a Phase 3 trial. After 48 weeks of therapy, all patients responding to treatment have now completed their 24-week follow-up. The unblinded data from the trial are expected to be available in the fourth quarter of 2008. The Phase 3 trial is evaluating ZADAXIN(R) (thymalfasin) in combination with pegylated interferon alpha and ribavirin as a treatment for patients with hepatitis C virus (HCV) who have not responded to prior therapy with pegylated interferon alpha and ribavirin. In February 2008, SciClone and Sigma-Tau S.p.A. announced promising blinded interim data from this trial.
The completion of the study is an important step toward unblinding the data. Previously reported data from this Phase 3 hepatitis C trial have been promising, said Mario Rizzetto, M.D., Professor of Gastroenterology, San Giovanni Battista Hospital, University of Torino, Italy, and lead investigator of the trial. The standard data review and analysis is underway with an unblinding of the data expected in late 2008.
We continue to believe that thymalfasin could represent an important advance in the treatment of non-responder hepatitis C patients and address a growing and acute need, said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc.
The treatment approach for HCV using a combination of thymalfasin together with pegylated interferon plus ribavirin is patent protected by SciClone in most major markets including the United States and Europe until 2021. Details of the thymalfasin triple therapy for HCV, the hepatitis C virus, and thymalfasin may be found in the press release from SciClone Pharmaceuticals dated February 11, 2008, at www.sciclone.com.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN(R) is currently being evaluated in a late-stage clinical trial for the treatment of hepatitis C, and successfully completed a phase 2 clinical trial in malignant melanoma. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. A key part of SciClone's strategy is to leverage its advantage and broaden its portfolio in the rapidly growing Chinese market by in-licensing or acquiring the marketing rights to other products, such as DC Bead(TM). For the U.S. market, SciClone's other clinical-stage drug development candidates are RP101 for the treatment of pancreatic cancer and SCV-07 for the treatment of hepatitis C. For more information about SciClone, visit www.sciclone.com.
About sigma-tau Group
Sigma-tau Group is a leading research-based Italian pharmaceutical company with a consolidated 2007 turnover of approximately EUR 665 million (US$ 920 million) and over 2500 employees worldwide. The therapeutic areas in which sigma-tau Group focuses its Research and Development include cardiovascular disease, metabolism, neurology, oncology and immunology, totalling 48 projects. Over 30 indications are explored in clinical trials with 24 molecules of which 17 are proprietary and the majority of them (14) are NCEs. Sigma-tau Group has operating subsidiaries throughout Europe and the U.S. and is active in every major pharmaceutical market. For additional information about sigma-tau Group, please visit www.sigma-tau.it.
SOURCE: SciClone Pharmaceuticals & Sigma-Tau Group |
