Healthcare Industry News: pegylated interferon
News Release - December 28, 2006
SciClone and Sigma-Tau Complete Enrollment in Phase 3 Triple Therapy Hepatitis C Clinical TrialSAN MATEO, CA--(Healthcare Sales & Marketing Network)--Dec 28, 2006 -- SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN ) and its European partner Sigma-Tau S.p.A. today announced that full patient enrollment is complete for its phase 3 clinical trial evaluating the use of ZADAXIN® (thymalfasin or thymosin alpha 1) in combination with pegylated interferon alpha and ribavirin to treat patients infected with the hepatitis C virus (HCV). This trial is being conducted by Sigma-Tau in Europe and has enrolled a total of 553 patients.
"We believe that ZADAXIN could increase the therapeutic efficacy of standard HCV treatment without additional side effects, particularly for non-responder HCV patients infected with a high viral load of the genotype 1 strain of the virus," said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "Having met our 2006 milestones with interim survival data from the phase 2 ZADAXIN melanoma trial announced last week and a regulatory submission in China for the DC Bead(TM) filing announced today, we believe that our management team continues to execute on our primary strategic objectives of building a leading pharmaceutical business in China and developing ZADAXIN for the U.S. and European markets."
"In the U.S. and Europe, there are more than seven million people chronically infected with the hepatitis C virus, and current therapy is insufficient for close to half of all patients," added Roberto Camerini, M.D., Research and Development for Sigma-Tau S.p.A. "Patients need new therapeutic alternatives, whether novel agents or additive compounds like ZADAXIN, which address the large and growing group of patients who have failed to respond to the current standard of care."
The phase 3, multi-center, double-blinded, randomized study enrolled 553 predominately genotype 1 HCV patients who have not responded to previous treatment with pegylated interferon alpha and ribavirin. Patients have been randomized to receive either ZADAXIN or a placebo, and all patients are receiving pegylated interferon alfa-2a and ribavirin. After completing 48 weeks of treatment, patients will be monitored for a 24-week observation period. The primary endpoint is sustained virological response (SVR), defined as the absence of HCV RNA measured at week 72, the end of the 24-week observation period. The secondary endpoints are normalization of ALT (an enzyme that when present in increased levels is an indicator of inflammation or damage of the liver) measured at the end of weeks 48 and 72, absence of HCV RNA measured at week 48, and an improvement in the liver biopsy. Data from this trial are expected to be publicly announced by year-end 2008.
ZADAXIN is SciClone's brand of a pure synthetic preparation of thymalfasin, a substance which circulates in the blood naturally. Thymalfasin has been shown to activate various arms of the immune system, leading to an increase in expression of MHC Class I receptors to allow the immune system to recognize virally infected cells, a decrease in apoptosis or cell death of white blood cells, and an enhancement of the T helper 1 (Th1) subset of T cells by increasing the production of the Th1 cytokines INF-gamma and IL-2. Because stimulation of Th1 cells is associated with a vigorous antiviral immune response, thymalfasin's effects on the immune system can explain its effectiveness in treatment of viral infections in animal models and previous clinical studies. Thymalfasin's multiple activities arise through activation of Toll-like receptor 9 and signaling through increases in the nuclear factor NFkB through Myd88 and IKKb. 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. and in combination with anti-viral and anticancer drugs, without any reported significant ZADAXIN-specific side effects or toxicities.
Sigma-Tau is a privately held, research focused pharmaceutical company headquartered in Pomezia (Rome), Italy. In 2005, Sigma-Tau had revenues of 674 million euros (US$ 900 million). Sigma-Tau has 2,400 employees, 400 of whom work in the research and development of products for therapeutic areas including cardiovascular, metabolism, central and peripheral nervous system, immunology and oncology.
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 late-stage clinical trials for the treatment of malignant melanoma and hepatitis C. 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 in China by in-licensing or acquiring the marketing rights to other products, such as the DC Bead, to broaden its portfolio in this rapidly growing pharmaceutical market. SciClone's other drug development candidate is SCV-07, currently in early clinical development in the U.S. for the treatment of viral infectious diseases. For more information about SciClone, visit www.sciclone.com.
The information in this press release contains forward-looking statements including our expectations and beliefs regarding future sales and financial results, and progress and results of our clinical trials. 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, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including changes in demand for ZADAXIN or DC Bead, the progress or failure of clinical trials, our actual experience in executing on our objectives, the performance of our partners, maintenance of the sufficiency and eligibility of the enrolled patient population, unanticipated delays or additional expenses incurred during our clinical trials, our future cash requirements, delays in analyzing and synthesizing data obtained from clinical trials, future actions of our strategic partners, unexpected delays in preparation for enrollment, future actions by the U.S. Food and Drug Administration or equivalent regulatory authorities in Europe and, with respect to DC Bead, in China, and 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, as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission.
Source: SciClone Pharmaceuticals
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