Dr. Eduardo Martins, Vice President of Medical Affairs of SciClone Pharmaceuticals, commented, "This is the first triple therapy study to evaluate ZADAXIN in combination with pegylated interferon alpha and ribavirin. These positive 12-week data support our previous data showing ZADAXIN used in combination with standard therapies has improved response rates for non-responders. We intend to analyze subsequent data from this study as well as consider future additional triple therapy studies. However, our primary clinical focus continues to be our two U.S. phase 3 clinical trials targeting ZADAXIN in combination with pegylated interferon alpha to be the first FDA approved therapy to specifically address the needs of non-responders."
The 12-week interim results from this triple therapy study were presented at the largest meeting of liver specialists in the world, the annual meeting of the American Association of the Study of Liver Disease (AASLD) on Saturday, October 25, 2003. This ongoing study plans to enroll a total of 50 hepatitis C non-responder patients in 5 sites throughout Mexico. None of the patients in this study have shown a response to prior therapy of interferon in combination with ribavirin.
Of the 23 patients who had completed 12 weeks of therapy, 61% (14/23) reported an EVR (a 2 log or greater reduction in the level of HCV RNA) and 48% (11/23) tested negative for HCV RNA by PCR test (Roche Amplicor). Of the 20 patients infected with the difficult to treat HCV genotype 1, 60% (12/20) reported an EVR and 50% (10/20) tested negative for HCV RNA. As in all previous ZADAXIN studies, the safety profile was excellent without significant drug related side effects or toxicities.
During the course of this study, patients will receive 12 months of triple therapy (ZADAXIN 1.6 mg/bi-weekly plus pegylated interferon alfa-2a 180 mcg/week and ribavirin 1,000 mg/day) and will be observed for 6 months after completing therapy to measure sustained response. The primary endpoint of the study is negative HCV RNA by PCR test (Roche Amplicor) measured at weeks 48 and 72. The secondary endpoints are normalization of ALT (a liver enzyme) measured at weeks 48 and 72 and reduction in HCV load measured at weeks 12, 24, 48, and 72.
This multicenter study is being conducted by a team lead by Dr. Jorge L. Poo, Chief Scientific Officer of CIF-Biotech at the Medica Sur hospital in Mexico City (www.cifbiotec.org.mx). Dr. Poo concluded, "These data suggest that ZADAXIN adds to the efficacy of pegylated interferon alpha plus ribavirin to induce an early virologic response in patients with hepatitis C who are non-responders to previous combination therapy. ZADAXIN was well tolerated with no obvious side effects." The triple therapy study is being funded and conducted by Laboratorios Colombia in Mexico with ZADAXIN provided free of charge by SciClone and PEGASYS brand pegylated interferon alpha provided free of charge by F. Hoffman La-Roche. ZADAXIN, PEGASYS and ribavirin are approved in Mexico for the treatment of hepatitis C.
About SciClone's Phase 3 Hepatitis C Trials
ZADAXIN is currently the only non-interferon based new hepatitis C therapy in phase 3 clinical trials in the U.S. SciClone's phase 3 HCV clinical trials are designed to provide statistically significant results, and together represent one of the largest HCV clinical studies of patients being currently conducted in the U.S. to date. The two trials are multi-center, randomized and double-blinded studies. The first trial includes patients with no cirrhosis and the second trial includes patients with mild cirrhosis of the liver.
SciClone completed full enrollment of its first 500 patient phase 3 hepatitis C clinical trial in September and targets full enrollment of its second 500 patient trial during the first quarter of 2004. SciClone expects all 1,000 patients to have completed the trial by the second half of 2005.
In each of the clinical trials, patients are assigned to a 12-month course of ZADAXIN plus with pegylated interferon alpha or placebo plus pegylated interferon alpha. After completing treatment, the patients will be followed for a six-month observation period. Primary endpoints are a sustained virological response (clearance of the hepatitis C virus) and an improvement in the liver histological activity index measured at the end of the six-month observation period.
About ZADAXIN
ZADAXIN is a pure synthetic preparation of thymosin alpha 1, a substance which circulates in the blood naturally and is instrumental in the body's immune response to fight viral infections and certain cancers. ZADAXIN is easily and safely administered just under the skin twice a week. After administration, thymosin alpha 1 circulates at 50 to 100 times its normal level in the body. 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. SciClone estimates that over 10,000 patients have used ZADAXIN in both clinical and commercial use, alone and in combination with anti-viral and anticancer drugs, without any reported significant ZADAXIN-specific side effects or toxicities.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone is currently evaluating its lead product ZADAXIN in several late stage clinical trials, including two phase 3 hepatitis C clinical trials in the U.S., a recently completed phase 3 hepatitis B clinical trial in Japan, a phase 2 malignant melanoma clinical trial in Europe, two phase 2 liver cancer pilot studies in the U.S., and a phase 3 hepatitis C pilot study in Mexico. Other drug development candidates include SCV-07, a potentially orally available therapeutic to treat viral and infectious diseases, and other products to treat cystic fibrosis. For more information about SciClone, visit www.sciclone.com.
The information in this press release contains forward-looking statements including the prospective development, commercialization and regulatory approval of ZADAXIN in the U.S. 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, 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 the fact that results from studies with a limited group of patients may not be predictive of the results of larger studies, EVR is not always predictive of the achievement of a sustained viral response which is the endpoint of the hepatitis C clinical trial, the speed with which patients are enrolled in the hepatitis C clinical trial, maintenance of the sufficiency and eligibility of the enrolled patient population, unexpected adverse results to patients and other events that could prolong the clinical trial or result in unanticipated expense, we may not receive hepatitis C approval for ZADAXIN in the U.S., future actions that may be taken by regulatory agencies, as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission.
Corporate information contact:
Richard A. Waldron, CFO
650-358-3437