Healthcare Industry News: influenza
News Release - May 25, 2006
SciClone Reports Final Results From Second ZADAXIN U.S. Phase 3 Hepatitis C TrialSAN MATEO, CA--(Healthcare Sales & Marketing Network)--May 25, 2006 -- SciClone Pharmaceuticals, Inc. (NasdaqNM:SCLN ) today reported final results from its second U.S. phase 3 hepatitis C virus (HCV) trial evaluating the benefit of adding ZADAXIN® to pegylated interferon alpha treatment for HCV patients with early cirrhosis of the liver who have failed prior therapy. Final results indicate that treatment with ZADAXIN plus pegylated interferon alpha did not demonstrate a statistically significant improvement compared with treatment with pegylated interferon alpha alone in sustained virologic response (SVR), the trial's primary endpoint. ZADAXIN was generally well tolerated with no treatment-related toxicities or side effects. In December 2005, SciClone reported final results from its first U.S. phase 3 HCV trial, which were consistent with these results and not statistically significant.
"Given these results, our ZADAXIN development efforts will be focused on advanced-staged malignant melanoma in conjunction with our European development and marketing partner, Sigma-Tau," commented Ira D. Lawrence, M.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "Further development of ZADAXIN in HCV will be dependent on the results achieved from the ongoing triple therapy HCV trial being conducted by Sigma-Tau in Europe that are expected in 2008. In addition to developing ZADAXIN as a treatment for melanoma, our clinical development plans include our proprietary drug candidate SCV-07, which has demonstrated broad therapeutic applicability in a variety of viral and other infectious diseases. Currently, we are conducting an oral comparison study with SCV-07 to determine its availability when administered orally, and in the second half of this year we expect to initiate a proof-of-concept clinical trial to evaluate the potential benefit of SCV-07 in an influenza vaccine dose sparing setting. Our business strategy also includes the expansion of our operations and product portfolio in China, and we are focused on growing sales in this market by in-licensing or acquiring the rights to at least one new product for China this year."
HCV patients in this second U.S. phase 3 clinical trial received a 48-week course of therapy of either ZADAXIN (1.6 mg, twice a week) and pegylated interferon alpha (180 mcg, once a week) or placebo and pegylated interferon alpha followed by a 24-week observation period. The trial's primary endpoint was the achievement of SVR at week 72.
Sigma-Tau is conducting an HCV trial in Europe to evaluate the efficacy of a triple therapy combination of ZADAXIN, pegylated interferon alpha and ribavirin. Results from this trial are not expected until 2008. The Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) generally require two confirmatory phase 3 clinical trials to support a regulatory filing. Should the results of this European triple therapy trial be statistically significant, they will likely be insufficient for a regulatory filing, and statistically significant results from a second triple therapy trial would be needed.
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. SciClone's strategy is to leverage its advantage in China by in-licensing or acquiring the marketing rights to other products to market 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 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 and beliefs regarding 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. 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 the progress of ongoing and proposed trials and studies for ZADAXIN and SCV-07, future actions of our collaborative partner, unexpected adverse results to patients, future actions by the U.S. Food and Drug Administration or equivalent regulatory authorities in Europe, the fact that experimental data and clinical results derived from pre-clinical studies or from studies with a limited group of patients may not be predictive of the results of larger studies, our ability to expand our operations, product portfolio and sales and marketing in China, as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission.
Source: SciClone Pharmaceuticals
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.